In Vitro Diagnostics (IVD) in United States Market

United States Market for In
Vitro Diagnostic Tests, 4th

Edition
October 2022
© Kalorama Information
United States Market for In Vitro Diagnostic Tests, 4th Edition
Table of Contents
CHAPTER 1: EXECUTIVE SUMMARY............................................................................................................ 1
U.S. IVD MARKET .............................................................................................................................................. 1

Table 1-1: U.S. IVD Market by Segment (Clinical Chemistry, Microbiology - ID/AST, Molecular,
Molecular Infectious Disease Molecular – non, Infectious Disease, POC Diabetes, POC – Other,
Immunoassay, Immunoassay Infectious Disease, Immunoassay non-Infectious, Coagulation,
Histology, Hematology, Blood Typing, and Others), 2022-2027 (in millions $) ..................................................... 3
Figure 1-1: U.S. IVD Market Segments (Clinical Chemistry, Microbiology - ID/AST, Molecular,
Histology, Hematology, Blood Grouping, and Others), by % of the total U.S. IVD Market, 2022 .......................... 4
TOP 12 U.S. IVD MARKET PARTICIPANTS AND RANKINGS .......................................................................................... 5
Table 1-2: U.S. IVD Market Rankings, by Estimated 2022 US Revenue – Top 12 Companies
(Abbott Diagnostics, Roche Diagnostics, Danaher Corporation, Siemens Healthcare Diagnostics,
Thermo Fisher Scientific, Becton, Dickinson & Co. (BD), Hologic, Illumina, Dexcom, bioMérieux,
Exact Sciences, and Ortho Clinical) ........................................................................................................................ 6
CONCLUSIONS .................................................................................................................................................... 7
CHAPTER 2: INTRODUCTION TO U.S. HEALTH CARE .................................................................................... 9
THE UNITED STATES AND IN VITRO DIAGNOSTICS...................................................................................................... 9

U.S. PATIENT POPULATION ................................................................................................................................ 11
Healthcare System Utilization ................................................................................................................. 11
Aging ....................................................................................................................................................... 12
Figure 2-1: U.S. Projects of Older Adult Population, 2016-2060 ............................................................... 12
Disease Prevalence and Incidence........................................................................................................... 13
Table 2-1: U.S. New Cancer Cases 2022 Estimates, by Type (Female Breast, Prostate, Lung
and Bronchus, Colon and Rectum, Corpus and Uterus, Melanomas of the Skin, Urinary Bladder,
Non-Hodgkin Lymphoma, Kidney and Renal Pelvis, Thyroid, and Pancreas) ...................................................... 15
Table 2-2 U.S. Estimated Cancer Deaths, by Cancer Type (Lung and Bronchus, Female Breast,
Prostate, Colon and Rectum, Pancreas, Ovary, Liver and Intrahepatic Bile Duct, Leukemias, Non-
Hodgkin Lymphoma, and Corpus and Uterus), 2022 ........................................................................................... 16
Table 2-3: Reported Cases of Selected Notifiable Diseases (Arboviral Diseases [incl. West
Nile], Babesiosis, Brucellosis, Chlamydia, Cholera, Coccidiodomycosis, Cryptosporidiosis, Dengue,
Ehrlichiosis/Anaplasmosis, Giardiasis, Gonorrhea, Hepatitis A, Hepatitis B, Hepatitis C, HIV/AIDS,
October 2022 © Kalorama Information i

Legionellosis, Listeriosis, Lyme Disease, Malaria, Meningococcal Disease, Pertussis, Q Fever,

Salmonellosis, Shiga toxin-producing E Coli, Shigellosis, Spotted Fever Rickettsiosis, Syphilis,
Tuberculosis, Vancomycin-intermediate Staphylococcus aureus, Vibriosis), U.S., 2016-2019, by
Case Count .......................................................................................................................................................... 19
U.S. Clinical Lab Expenditure ................................................................................................................... 21
Table 2-4: U.S. Clinical Lab Market by Channel (Hospital Labs/Acute Care Labs, Independent
Labs, and Physician Office Labs/Outpatient Labs), 2021-2026 (% of Market) ..................................................... 22
Preventive Health Care .............................................................................................................................. 22
Product Innovation from Value-Based Pricing ........................................................................................... 23
CLINICAL TESTING UNDER MEDICARE – REIMBURSEMENT CUTS AND MARKET-BASED PRICING ....................................... 24
Protecting Access to Medicare Act of 2014 (PAMA) ............................................................................... 26
Table 2-5: Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2025 .............................................. 26
Impact of CARES Act on PAMA .................................................................................................................. 27
PRECISION MEDICINE AND NGS .......................................................................................................................... 29
LABORATORY-DEVELOPED TESTS (LDTS) ............................................................................................................... 31
Changes Resulting from COVID-19 Pandemic ......................................................................................... 32
COVID-19 IMPACT .......................................................................................................................................... 35
U.S. HEALTHCARE INFRASTRUCTURE AND TESTING CHANNELS................................................................................... 36
Hospitals ................................................................................................................................................. 36
Independent Labs .................................................................................................................................... 37
Physician Office Laboratories .................................................................................................................. 38
At-Home Testing ..................................................................................................................................... 38
Home Collection Trend ............................................................................................................................ 38
Retail Clinics ............................................................................................................................................ 39
CONCLUSIONS .................................................................................................................................................. 40
CHAPTER 3: U.S. IVD MARKET ANALYSIS .................................................................................................. 41
CLINICAL CHEMISTRY ......................................................................................................................................... 42

Table 3-1: U.S. Clinical Chemistry Market (General Chemistry, Blood Gases, and Urinalysis)
2022-2027 (in millions $) est ............................................................................................................................... 42
Figure 3-1: U.S. Clinical Chemistry Market, 2022-2027 ($ millions) ........................................................... 43
MICROBIOLOGY AND VIROLOGY – ID/AST AND MOLECULAR .................................................................................... 44
Table 3-2: US ID/AST Microbiology ID/AST Market (ID/AST Auto, ID/AST Panels, Blood
Culture, Chromogenic Media, and Rapid Micro) 2022-2027 ($ millions) ............................................................ 45
Figure 3-2: U.S. ID/AST Microbiology Market (Auto ID/AST, Manual ID/AST, Blood Culture,
Chromogenic Media, Rapid, Micro) 2022-2027 ($ millions) ................................................................................ 45
Molecular Infectious Disease .................................................................................................................. 48
Table 3-3: U.S. Molecular Infectious Disease, Market Distribution Estimates by Segment
(HAI/Sepsis, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Molecular
including Parasitology, Mycology, Malaria, Chagas, Dengue, etc.), 2022-2027 (%) ............................................ 49
ii October 2022 © Kalorama Information

Figure 3-3: U.S. Molecular Microbiology / Virology Market Distribution Estimates by

Segment, (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Microbiology),
2022 (%) .............................................................................................................................................................. 50
POINT-OF-CARE TESTING ................................................................................................................................... 53
Table 3-4: U.S. Point-of-Care (POC) Diagnostics Markets (Glucose, Blood & Electrolytes,
Coagulation, Cardiac Markers, Drugs of Abuse, Pregnancy & Fertility, Fecal Occult Blood, Infectious
Disease, Lipid, Cancer Tumor Markers, Urine, Miscellaneous), 2022 and 2027 ($ millions) ............................... 54
Figure 3-4: U.S. POC Diabetes Market, 2022-2027 (in millions $) .............................................................. 55
Figure 3-5: U.S. POC Market without Diabetes, 2022-2027 (in millions $) ................................................ 55
IMMUNOASSAYS ............................................................................................................................................... 56
Non-Infectious Disease Immunoassay .................................................................................................... 56
Table 3-5: U.S. Immunoassays Market – Non Infectious (Cardiac Markers, Tumor Markers,
Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D, HbA1c,
others) 2022-2027 ($ millions) ............................................................................................................................ 57
Figure 3-6: U.S. Immunoassay-Non-infectious (Cardiac Markers, Tumor Markers,
Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D, HbA1c,
others), 2022-2027 (in millions) $) ...................................................................................................................... 58
Infectious Disease Immunoassay ............................................................................................................ 58
Table 3-6: U.S. Immunoassays Market – Infectious (Hepatitis, HIV, STDs, ToRCH, Respiratory,
HAIs/Sepsis, Others), 2022-2027 (in millions $) .................................................................................................. 59
Figure 3-7: U.S. Immunoassay Infectious Disease (Hepatitis, HIV, STDs, ToRCH, Respiratory,
HAI/Sepsis, Others), 2022-2027 (in millions $) .................................................................................................... 60
MOLECULAR NON-INFECTIOUS DISEASE DIAGNOSTICS ............................................................................................. 62
Figure 3-8: U.S. Molecular Non-Infectious Disease Diagnostics Market, 2022-2027 ($ millions) .............. 63
COAGULATION ................................................................................................................................................. 66
Table 3-7: U.S. Coagulation Diagnostics Market by Segment , PT/INR, Molecular-lab
Thrombophilia SNPs, D-Dimer, 2022-2027 (in millions $) ................................................................................... 67
Figure 3-9: U.S. Coagulation Diagnostics Market, 2022-2027 ($ millions) ................................................. 67
HISTOLOGY ...................................................................................................................................................... 68
Table 3-8: U.S. Histology/Cytology IVD Market by Segment (Pap Tests, in situ Hybridization,
Immunohistochemistry, Traditional non-Pap Stains, HPV Molecular) 2022-2027 ($ millions) ........................... 68
Figure 3-10: U.S. Histology and Cytology Diagnostics Market, 2022-2027 ($ millions).............................. 69
HEMATOLOGY .................................................................................................................................................. 70
Table 3-9: U.S. Lab-based Hematology Market by Analyte Segment (CBC, Hemoglobin, and
Other), 2022-2027 (in millions $) ........................................................................................................................ 71
Figure 3-11: U.S. Hematology Diagnostics Market, 2022-2027 ($ millions) ............................................... 71
BLOOD TESTING AND TYPING .............................................................................................................................. 74
Table 3-10: U.S. Blood Testing and Typing by Segment (ABO Grouping/Typing and Screening),
2022-2027 (in millions $) ..................................................................................................................................... 75
Figure 3-12: U.S. Blood Grouping and Typing Diagnostics Market, 2022-2027 ($ millions) ....................... 75
Figure 3-13: U.S. Blood Screening Diagnostics Market (Immunoassay Blood Screening and
NAT Blood Screening), 2022-2027 ($ millions) .................................................................................................... 76
TOTAL U.S. IVD MARKET .................................................................................................................................. 77
October 2022 © Kalorama Information iii

Table 3-11: U.S. IVD Market including COVID-19, by Segment (Clinical Chemistry,
Microbiology - ID/AST, Molecular, Molecular Infectious Disease Molecular – non, Infectious
Disease, POC Diabetes, POC – Other, Immunoassay, Immunoassay Infectious Disease,
Immunoassay non-Infectious, Coagulation, Histology, Hematology, Blood Typing, and Others),
2022-2027 (in millions $) .................................................................................................................................... 79
Figure 3-14: U.S. IVD Market Segments (Clinical Chemistry, Microbiology - ID/AST, Molecular,
Histology, Hematology, Blood Typing, and Others), 2022 (%)............................................................................. 80
CHAPTER 4: TOP TIER U.S. IVD MARKET PLAYERS ..................................................................................... 81
Table 4-1: 2021 U.S. IVD Competitor Revenues ($ millions) .................................................................... 81

ABBOTT DIAGNOSTICS ....................................................................................................................................... 82
Recent Revenue History .......................................................................................................................... 82
Table 4-2: Abbott Diagnostic Revenues 2017-2021 (millions $) ................................................................ 82
Figure 4-1: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated .......................... 82
Table 4-3: Global Abbott Diagnostic Revenues, 2017-2021 (millions $) ................................................... 83
Core Lab .................................................................................................................................................. 83
Hematology............................................................................................................................................. 84
Blood Banking ......................................................................................................................................... 85
Infectious Diseases - Molecular............................................................................................................... 85
Diabetes .................................................................................................................................................. 86
HIV Point of Care ..................................................................................................................................... 88
i-STAT Business........................................................................................................................................ 88
COVID-19................................................................................................................................................. 89
BECKMAN COULTER, INC. / DANAHER .................................................................................................................. 91
Recent Revenue History .......................................................................................................................... 91
Table 4-4: Beckman Coulter Diagnostic Revenues 2017-2021 (millions $) ................................................ 91
Figure 4-2: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated .......................... 91
Table 4-5: Global Beckman Coulter Revenues in Selected Test Segments 2019-2021 (millions
$) estimated ........................................................................................................................................................ 92
Hematology............................................................................................................................................. 92
Hematology IT ......................................................................................................................................... 95
Clinical Chemistry .................................................................................................................................... 96
Immunoassays ........................................................................................................................................ 97
Microbiology ........................................................................................................................................... 99
Molecular Tissue Analysis ..................................................................................................................... 100
Flow Cytometry ..................................................................................................................................... 100
Beckman Coulter Life Sciences .............................................................................................................. 102
COVID-19............................................................................................................................................... 102
BECTON, DICKINSON AND COMPANY (BD) .......................................................................................................... 104
iv October 2022 © Kalorama Information

Recent Revenue History ........................................................................................................................ 104

Table 4-6: BD Diagnostic Revenues 2017-2021 (millions $) ..................................................................... 104
Figure 4-3: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated ........................ 104
Table 4-7: Global BD Revenues in Flow Cytometry 2017- 2021 (millions $) ........................................... 105
Cytology ................................................................................................................................................ 106
Molecular Microbiology ........................................................................................................................ 106
Traditional Microbiology - ID/AST ......................................................................................................... 107
Blood Culture ........................................................................................................................................ 108
Hospital Acquired Infections .................................................................................................................... 109
Blood Collection .................................................................................................................................... 110
Mass Spectrometry ............................................................................................................................... 110
Flow Cytometry ..................................................................................................................................... 111
COVID-19............................................................................................................................................... 113
BIOMÉRIEUX .................................................................................................................................................. 115
Table 4-8: bioMérieux IVD Revenues, 2017-2021 (millions $) ................................................................ 115
Table 4-9: bioMérieux Revenues in Selected Test Segments, 2017-2021 (millions $) ............................ 116
Traditional Microbiology ....................................................................................................................... 116
Blood Culture ........................................................................................................................................ 117
Immunoassays ...................................................................................................................................... 117
BIOFIRE Diagnostics Business................................................................................................................ 118
COVID-19............................................................................................................................................... 119
BIO-RAD LABORATORIES, INC............................................................................................................................ 121
Table 4-10: Bio-Rad Diagnostics Revenues 2017-2021 (millions $)......................................................... 121
Table 4-11: Global Bio-Rad Revenues in Selected Test Segments 2017-2021 (millions $)....................... 122
Blood Bank ............................................................................................................................................ 123
Diabetes ................................................................................................................................................ 123
Immunoassays ...................................................................................................................................... 124
COVID-19............................................................................................................................................... 125
CEPHEID / DANAHER ....................................................................................................................................... 126
Table 4-12: Cepheid Revenues 2017-2021 (millions $) ........................................................................... 126
GeneXpert Xpress Line .......................................................................................................................... 127
Tuberculosis .......................................................................................................................................... 127
Microbiology ......................................................................................................................................... 128
POC Testing ........................................................................................................................................... 129
Cancer ................................................................................................................................................... 129
COVID-19............................................................................................................................................... 129
October 2022 © Kalorama Information v

DANAHER CORPORATION ................................................................................................................................. 131

Table 4-13: Danaher Diagnostics Revenues 2017-2021 (millions $) ....................................................... 131
Figure 4-6: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions)
estimated .......................................................................................................................................................... 132
DEXCOM ....................................................................................................................................................... 133
Table 4-14: 2017-2021 Dexcom Revenue History ($ million) .................................................................. 133
estimated .......................................................................................................................................................... 133
EXACT SCIENCES ............................................................................................................................................. 136
Table 4-15: Exact Sciences Revenue History, 2017-2021 (in $ millions) .................................................. 136
Figure 4-8: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in
millions)estimated............................................................................................................................................. 136
COVID-19............................................................................................................................................... 138
HOLOGIC, INC. ............................................................................................................................................... 139
Table 4-16: Hologic Revenues 2017-2021 (millions $) ............................................................................. 139
estimated .......................................................................................................................................................... 139
Table 4-17: Global Hologic Revenues in Selected Test Segments 2017-2021 (millions $) ...................... 140
PANTHER Molecular System ................................................................................................................. 141
Panther Fusion ...................................................................................................................................... 142
Infectious Diseases ................................................................................................................................ 143
Sexually Transmitted Infections ............................................................................................................ 144
Cytology ................................................................................................................................................ 145
COVID-19............................................................................................................................................... 145
ILLUMINA ...................................................................................................................................................... 148
Table 4-18: Illumina Revenue History ($ million – not all revenues are for clinical products
and services; estimated) ................................................................................................................................... 148
estimated .......................................................................................................................................................... 148
Table 4-19: Illumina Diagnostic Revenues by Segment ($ million) est..................................................... 149
COVID-19............................................................................................................................................... 155
ORTHO CLINICAL DIAGNOSTICS (QUIDELORTHO) .................................................................................................. 156
Table 4-20: Ortho Clinical Diagnostics Revenues 2017-2021 (millions $) ................................................ 156
estimated .......................................................................................................................................................... 157
Table 4-21: Global Ortho Clinical Diagnostics Revenues in Selected Test Segments 2021
(millions $) ......................................................................................................................................................... 157
Blood Bank ............................................................................................................................................ 158
Core Lab / Immunoassays ..................................................................................................................... 160
vi October 2022 © Kalorama Information

COVID-19............................................................................................................................................... 161
QIAGEN N.V. .............................................................................................................................................. 162
Table 4-22: QIAGEN N.V. IVD Revenues 2017-2021 (millions $) .............................................................. 162
Figure 4-12: 2021 QIAGEN IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in
millions) estimated ............................................................................................................................................ 163
Table 4-23: Global QIAGEN IVD Revenues by Type, 2017-2021 (million) ............................................... 163
Tuberculosis .......................................................................................................................................... 165
Lyme Disease......................................................................................................................................... 167
Molecular Expansion ............................................................................................................................. 167
Precision Medicine / Companion Diagnostics ....................................................................................... 168
Molecular Microbiology ........................................................................................................................ 170
Prenatal Testing .................................................................................................................................... 171
Next Generation Sequencing................................................................................................................. 172
Digital PCR ............................................................................................................................................ 173
Liquid Biopsy ......................................................................................................................................... 174
COVID-19............................................................................................................................................... 174
QUIDEL CORPORATION (QUIDELORTHO) ............................................................................................................. 177
Table 4-24: Quidel Revenue History ($ million) ....................................................................................... 177
Figure 4-13: 2021 QIAGEN IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in
Table 4-25: Quidel Diagnostic Revenues by Segment ($ million) est ....................................................... 178
Immunoassays ...................................................................................................................................... 179
Rapid Immunoassays ............................................................................................................................ 180
The Solana Business .............................................................................................................................. 181
Molecular – Savanna ............................................................................................................................ 182
COVID-19............................................................................................................................................... 182
PERKINELMER ................................................................................................................................................ 184
Table 4-26: PerkinElmer Revenue History, 2017-2021 ($ million, estimated) ........................................ 184
Figure 4-14: 2021 PerkinElmer IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in
Table 4-27: PerkinElmer Diagnostic Revenues by Segment, 2017-2021 ($ million) est ........................... 185
Diagnostics ............................................................................................................................................ 186
Sequencing /Genomics .......................................................................................................................... 187
Liquid Biopsy ......................................................................................................................................... 188
Histology ............................................................................................................................................... 189
Prenatal Business .................................................................................................................................. 189
Lab Services ........................................................................................................................................... 190
COVID-19............................................................................................................................................... 191
ROCHE DIAGNOSTICS....................................................................................................................................... 193
October 2022 © Kalorama Information vii


Table 4-28: Roche IVD Diagnostics Revenues 2017-2021 (millions $) ..................................................... 193
Figure 4-15: 2021 Roche IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in
Table 4-29: Global Roche IVD Diagnostics Revenues by Type, 2017-2021 (million) .............................. 194
Hematology........................................................................................................................................... 194
Immunoassays ...................................................................................................................................... 195
Core Molecular ...................................................................................................................................... 196
Digital PCR ............................................................................................................................................ 197
Diabetes Care ........................................................................................................................................ 197
cobas Liat System – POC ....................................................................................................................... 198
HPV ....................................................................................................................................................... 198
Blood Bank ............................................................................................................................................ 199
Cancer Companion Testing ................................................................................................................... 199
COVID-19............................................................................................................................................... 200
SIEMENS HEALTHINEERS (SIEMENS) ................................................................................................................... 202
Table 4-30: Siemens Healthineers IVD Revenues 2017-2021 (millions $) ................................................ 202
Figure 4-16: 2021 Siemens Healthineers IVD Diagnostic U.S. Revenues vs Non U.S. IVD
Revenues ($in millions) estimated .................................................................................................................... 202
Table 4-31: Global Siemens Healthineers IVD Revenues by Type, 2021 (million) .................................... 203
Core Lab ................................................................................................................................................ 204
Immunoassays ...................................................................................................................................... 204
Hematology........................................................................................................................................... 205
Molecular .............................................................................................................................................. 205
Acute Care – POC .................................................................................................................................. 206
COVID-19............................................................................................................................................... 206
SYSMEX CORPORATION .................................................................................................................................... 208
Table 4-32: Sysmex IVD Revenues 2017-2021 (millions $) ...................................................................... 208
Figure 4-17: 2021 Sysmex IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in
Table 4-33: Global Sysmex IVD Revenues by Type, 2017-2021 (million) ................................................ 209
Hematology........................................................................................................................................... 210
Coagulation ........................................................................................................................................... 211
Urinalysis............................................................................................................................................... 211
Flow Cytometry ..................................................................................................................................... 212
Precision Medicine / Companion Test Diagnostics................................................................................ 212
THERMO FISHER SCIENTIFIC INC......................................................................................................................... 213
Table 4-34: Thermo Fischer IVD Revenues 2017-2021 (millions $) ......................................................... 213
viii October 2022 © Kalorama Information

Figure 4-18: 2021 Thermo Fisher IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in
Table 4-35: Global Thermo Fisher IVD Revenues by Type, 2017-2021 (million) ..................................... 214
Immunoassays ...................................................................................................................................... 215
Microbiology ......................................................................................................................................... 216
Molecular Test Business ........................................................................................................................ 216
Next Generation Sequencing................................................................................................................. 217
qPCR ...................................................................................................................................................... 218
Oncology Companion Diagnostics ........................................................................................................ 218
COVID-19............................................................................................................................................... 219
October 2022 © Kalorama Information ix

Chapter 1: Executive Summary
U.S. IVD Market
The U.S. market dominates the IVD industry by region. In 2022, the U.S. occupies 42%
and about $54 billion of the global market for IVD products. This major IVD market is in a
state of flux, trying to manage a myriad of issues, all of which collide with a huge system
that costs more than any other in the world.
COVID-19 has had a profound effect on the IVD industry – some segments exploded, and
others languished. At this point in time, it is hard to predict how the Coronavirus will
impact the forecast years to 2027, but Kalorama has attempted to provide insight into the
industry by conversing with market participants and government entities. It is realistic to
assume the market for COVID-19 will remain a component of the IVD market as the
continued prevalence of the virus and the evolving variants are expected to remain. It
should be noted that the market can be uncertain and ongoing research will help determine
the long-term path of the segment in the coming months to years.
The POC diagnostics market represents the largest IVD segment in the United States;
consisting of both the POC diabetes segment ($8,617 million, 2022) and POC non-diabetes
segment ($11,996 million, 2022), which includes infectious disease (including COVID-19).
The large market segment reflects the diversity of diagnostic technologies that migrated to
near-patient settings and the importance of POC testing for preventative care; not to
mention the strong demand for COVID-19 POC tests over the past two years.
The third- and fourth-largest U.S. IVD segments, immunoassay infectious disease and
molecular microbiology, were certainly buoyed by the need for COVID-19 testing. The
majority of immunoassay testing volume in the United States is run on core lab
immunoassay analyzers or combined immunochemistry instruments.
More dynamic IVD segments in the U.S. market include microbiology, molecular
diagnostics, and histology. The leading growth rates for molecular diagnostics and
histology out of all segments in the U.S. IVD market are products of their roles in rapid and
sensitive pathogen detection, accurate viral load monitoring, and, in oncology, from risk
assessment through tumor monitoring. Cancer represents one of the most burdensome
October 2022 © Kalorama Information 1

diseases on the U.S. healthcare system. Demographic aging in the United States will
continue to increase nationwide cancer incidence.
Molecular diagnostics are uniquely responsive to infectious disease threats in the United
States. Market growth for molecular infectious disease tests in the United States exploded
in 2020 and has carried through to 2022 due to the pandemic.
Rising analytical speeds in sequencing allows for the rapid development of new probe and
primer reagents for use in molecular test kits. Future clinical molecular assays for infectious
disease may directly incorporate sequencing due to the technology’s ability to openly read
pathogenic genomes for new resistance genes and other traits significant in therapy
decisions.
Market performance between U.S. IVD segments has been inconsistent due to the
pandemic. Core lab market segments in the United States are projected to grow by a little
more than 1.1% through 2027.
In wider context, the United States remains the core geographical IVD market in the world
at over $54 billion in sales or approximately 42% of the global market. Market growth in
some segments in the United States has been accelerated due to the pandemic and the need
for testing for COVID-19. The U.S. IVD market is projected by Kalorama Information to
reach over $59 billion in 2027.
2 October 2022 © Kalorama Information

Table 1-1: U.S. IVD Market by Segment (Clinical Chemistry, Microbiology - ID/AST, Molecular, Molecular
Infectious Disease Molecular – non, Infectious Disease, POC Diabetes, POC – Other, Immunoassay,
Immunoassay Infectious Disease, Immunoassay non-Infectious, Coagulation, Histology, Hematology,
Blood Typing, and Others), 2022-2027 (in millions $)
Segment 2022 2027 CAGR
Clinical Chemistry $3,481 $3,671 1.1%
Microbiology - ID/AST 1,775 $2,089 3.3%
Molecular
$9,907 $10,074 0.3%
Molecular Infectious Disease
$8,081 $7,178 -2.3%
(with NAT & mass spec)
$1,826 $2,897 9.7%
Molecular - non-Infectious Disease
POC Diabetes (all) $8,617 $11,502 5.9%
POC - Other $11,996 $11,210 -1.3%
Immunoassay $12,891 $14,225 2.0%

Immunoassay Infectious Disease $8,315 $8,813 1.2%
Immunoassay non-Infectious $4,576 $5,412 3.4%
Coagulation $1,068 $1,266 3.5%
Histology $1,822 $2,254 6.2%
Hematology $1,895 $2,242 3.4%
Blood Typing $507 $539 1.3%
Others $74 $81 1.8%
Total $54,033 $59,154 1.8%
Source: Kalorama Information

Figure 1-1: U.S. IVD Market Segments (Clinical Chemistry, Microbiology - ID/AST, Molecular, Molecular
Blood Grouping, and Others), by % of the total U.S. IVD Market, 2022

Top 12 U.S. IVD Market Participants and Rankings
The total combined IVD sales of the top 12 companies profiled in this report are estimated
by Kalorama Information to represent nearly 71% of the total U.S. IVD market. Abbott
Diagnostics leads all market players in the United States with a comprehensive presence in
the core lab, molecular diagnostics, and a top-five presence in the global market for blood
glucose self-monitoring products. The top three IVD companies in the United States
(Abbott, Roche, and Danaher [Beckman Coulter]) are each leaders in core lab integrated
chemistry or workstation instruments that perform high-volume clinical chemistry and
immunodiagnostic testing.

Table 1-2: U.S. IVD Market Rankings, by Estimated 2022 US Revenue – Top 12 Companies (Abbott
Diagnostics, Roche Diagnostics, Danaher Corporation, Siemens Healthcare Diagnostics, Thermo Fisher
Scientific, Becton, Dickinson & Co. (BD), Hologic, Illumina, Dexcom, bioMérieux, Exact Sciences, and Ortho
Clinical)
Company Rank IVD Strengths
Core Lab Integrated Chemistry, Diabetes Self-Testing, Point-of-Care

Abbott Diagnostics 1
and Near Patient Testing, Hematology, Molecular Diagnostics
Core Lab Integrated Chemistry, Molecular Diagnostics, Diabetes Self-

Roche Diagnostics 2
Testing, Histology
Danaher Corporation
Hematology, Core Lab Integrated Chemistry, Flow Cytometry,
(Beckman Coulter, Leica Biosystems, 3
Histology, Urinalysis, Professional POC Diagnostics
Radiometer, Cepheid)
Core Lab Integrated Chemistry, Coagulation, Urinalysis, Hematology,

Siemens Healthcare Diagnostics 4
Microbiology
Thermo Fisher Scientific 5 Immunoassays, Microbiology, Molecular Diagnostics, Histology
Becton, Dickinson & Co. (BD) 6 Microbiology, Molecular Diagnostics, Flow Cytometry
Hologic 7 Histology, Molecular Diagnostics, Blood Banking
Illumina 8 Sequencing, microarray
Dexcom 9 CGM
bioMérieux 10 Microbiology, Immunoassays, Molecular Diagnostics
Exact Sciences 11 Molecular genome cancer diagnostic testing
Ortho Clinical 12 Core Lab Integrated Chemistry, Blood Banking

Conclusions
The following are among the main conclusions of this report:
• The U.S. IVD market is highly developed and, in some segments, dominated by a
handful of leading market players. In addition to molecular non-infectious disease
diagnostics (+9.7%), POC diabetes (+5.9%) and histology (+4.3%) are expected to
contribute the most growth to the U.S. IVD market.
• Future U.S. IVD market growth will be a product of several factors including
demographic aging; diminishing year-over-year gains on patient volumes and
healthcare utilization; modest economic growth and stability in the U.S. market; and
the introduction of new diagnostic technologies, particularly in the treatment of
cancer and critical infections
• Anticipated market difficulties include the transition of Medicare test pricing and
subsequent payment reductions to clinical labs; continued pricing pressure on
glucose testing supplies; and declining U.S. volumes of blood transfusions.
• Previous projections of U.S. molecular diagnostics market growth proved optimistic

prior to COVID-19 pandemic as the market fought through newly introduced
molecular coding in 2013 that resulted in coverage gaps and reduced pricing for
many molecular assays. New obstacles to market growth include payer imposition
of new requirements on molecular assay reimbursement such as the demonstration
of clinical utility and market-based CMS pricing of high-volume molecular tests.
Nevertheless, molecular diagnostics in the United States will benefit and continue to
grow through product innovation; introduction of companion diagnostics with
demonstrated clinical utility in trials; and the penetration of molecular diagnostics in
new client markets (with limits) including hospital labs, POLs, and other outpatient
clinics.
• Core lab IVD market segments – clinical chemistry, non-infectious immunoassays,

and microbiology ID/AST – are projected to average 1% - 4% annual market
growth. Relatively shallow growth is a feature of core lab markets in developed
countries. In the saturated U.S. market, core lab IVD market growth will be
sustained through gradually rising testing volumes related to higher patient
utilization of health care and continued lab investment in instrument and
workstation upgrades that reduce the cost of testing.

• COVID-19 had a profound effect on the U.S. IVD market in 2020 and 2021 and
will continue to influence the market in 2022 and beyond. Many IVD segments felt
the pressures of lockdowns, restrictions, staffing shortages, and other allocation
deficits. It is realistic to assume that COVID-19 will continue to be a component in
U.S. IVD market as the continued prevalence of the virus and the evolving variants
are expected to remain.

Chapter 2: Introduction to U.S. Health Care
The United States and In Vitro Diagnostics
IVD diagnostics are an important part of the United States healthcare market. The U.S.
healthcare market serves as an incubator for medical technologies and treatments that are
often subsequently marketed to the rest of the world. Unsurprisingly, the United States is
also the world’s largest in vitro diagnostics (IVD) market at $54 billion or approximately
40%-45% of the global IVD market. Projected growth for the U.S. IVD market totals 1.9%
on average annually through 2027.
COVID-19 had a profound effect on the IVD diagnostic industry – some segments
exploded, and others languished. At this point in time, it is hard to predict how the
coronavirus will impact the forecast years to 2027, but it is generally thought that as the
pandemic tracks toward endemic, COVID -19 will affect the industry less and less and will
become part of the regular infectious disease market.
Revenues in core lab test markets (hematology, clinical chemistry, non-infectious

immunoassays) either grew very slowly or decreased in 2022. This represented a settling of
the industry and a return to pre-pandemic growth. Moving forward, the U.S. IVD market
can expect moderate growth through the following market factors and trends; demographic
aging that increases demand for clinical testing paid for through the country’s leading
vehicle for lab payments (Medicare); and continued product innovation and industry
responsiveness to clients’ needs in the world’s largest IVD market.
Factors that may dampen IVD market growth include economic downturns; frequent
government targeting of clinical testing for overall Medicare and Medicaid cost savings;
related private payer insistence on test payment rates in line or lower than government
reimbursement rates; the vulnerability of U.S. economic growth in an increasingly
globalized economy; and the extensive approval processes (both for marketing and
coverage) applied to new IVD technologies and tests. The United States is a core market for
any IVD segment and the leading opportunity for the highest growth IVD segments –POC
assays (infectious disease and other) and histology. POC markets both diabetes and other
segments are expected to continue to grow substantially. Kalorama Information’s
conservative projection of a $54 billion U.S. IVD market in 2022 acknowledges its recently

demonstrated vulnerabilities of the volatile COVID-19 market and competing pricing

pressures, but also accounts for the selected strengths found among its segments.

U.S. Patient Population
The following sections review several trends in U.S. health and the patient population
pertinent to domestic IVD market demand including healthcare system utilization:
demographic aging, and the incidence and prevalence of various diseases. Contemporary
and recent historical trends are reviewed and are coupled with anticipated developments to
inform the market projections of this report.
Healthcare System Utilization
Clinical testing volumes are fundamentally products of patient utilization of the U.S.
healthcare system. The majority of in vitro diagnostic tests completed in the United States
originate as orders or requisitions from physicians to a clinical laboratory. Healthcare
system utilization – measured through inpatient and outpatient visits and procedures –
necessarily involves clinical lab testing as part of diagnosis, admission, and monitoring.
Generally speaking, U.S. IVD market growth can be achieved through (1) higher product
pricing, (2) a shift in clinical testing mix towards more sophisticated and specialized tests
(e.g., molecular assays or tests using gene-based reagents), (3) the introduction of new
products in response to unmet clinical demand, (4) more intensive testing per patient
episode, and (5) the expansion of the patient population through greater healthcare system
utilization.
In past years, U.S. IVD market growth has been accomplished primarily through the second
and third factors:
• Shift in clinical testing towards more sophisticated and specialized tests (e.g.
molecular diagnostic assays of nucleic acid targets and histology and cytology tests
performed on tissue and cells respectively)
• Introduction of new diagnostic products (tests and platforms) in response to unmet

clinical demand, often upgrades in clinical lab capabilities or capacity including the
notable decentralization of molecular testing to hospital labs and near-patient points
of care
• Technological advancements that allow new types of testing and new means of
testing.

Aging
The aging population continues to be an increasing factor in the delivery and outcome of
health care. As people age, they typically require more care and medicine. Essentially, the
increasing number of individuals in higher age brackets is expected to increase the demand
for health care.
The global population above age 65 is expected to grow by 279% between 2000 and 2050.
The percentage of people over the age of 65 is expected to reach almost 1.6 billion by 2050,
representing 16.7% of the population. This is in contrast to 533 million in 2010 which
represented 7.8% of the population-nearly doubling the distribution of over 65 population.
The year 2030 marks a demographic turning point for the United States. Beginning that
year, all baby boomers will be older than 65. This will expand the size of the older
population so that one in every five Americans is projected to be retirement age. Later that
decade, by 2034, it is projected that older adults will outnumber children for the first time
in U.S. history.
Figure 2-1: U.S. Projects of Older Adult Population, 2016-2060
Source: U.S. Census Bureau

Disease Prevalence and Incidence
Six in ten adults in the United States have a chronic disease and four in ten adults have two
or more chronic diseases. Some of the costliest chronic diseases to the health system
include asthma, cancer, chronic obstructive pulmonary disorder (COPD), congestive heart
failure (CHF), coronary artery disease (CAD), stroke, osteoarthritis, Alzheimer’s, chronic
kidney disease and diabetes. Additionally, the impact of alcohol-related health conditions
and substance abuse is adding additional pressure on health systems. With all of these
diseases, patient monitoring can improve outcomes and reduce costs by decreasing
hospitalizations and emergency room visits.
Trends in disease prevalence and incidence can reveal clinical drivers delivering growth to
select IVD segments. For instance, high-burden diseases in the United States such as
cardiovascular disease, cancer and diabetes contribute to testing volume for lipids and
integrated chemistry screens; histology and molecular diagnostics; and glucose tests,
respectively. Non-communicable disease burdens represent a significantly greater public
health challenge in the United States than infectious disease burdens.
Leading non-communicable or chronic diseases in the United States are cancer, heart
disease, and diabetes. One in three deaths in the United States is caused by cardiovascular
diseases costing the healthcare system $216 billion.
The incidence of myocardial infarctions or heart attacks in the United States is believed to
have fallen over the past decade; heart attack incidence rates among U.S. male populations
have consistently fallen since the 1980s. Hospital discharge volumes for coronary heart
disease have declined significantly since 2000 among both U.S. men and women. While the
worst effects of heart disease appear to have been mitigated, the stable prevalence of heart
disease in the United States continues to support voluminous lipid and cardiac marker
testing, both in routine care and as part of critical and emergency care. Despite the wide
availability and usage of troponin I and T, CK-MB, and BNP markers, IVD development
efforts continue to integrate more sensitive subsets of cardiac markers or marker panels into
critical care tests.
Diabetes prevalence among U.S. adults has trended upward for over a decade. A high-
income country with a substantial diabetic population, the United States is the world’s
largest diabetes testing market. Growth opportunities are limited in diabetes testing or self-
monitoring of blood glucose (SMBG); test strips have faced severe pricing pressure which

has led in recent years to across-the-board revenue decline among the major competitors in
the U.S. market.
However, the introduction and subsequent uptake of continuous glucose monitors have
provided high growth opportunities for industry providers. Continuous glucose monitoring
(CGM) is considered the most significant breakthrough in diabetes management in the past
40 years. CGM augments the use of glucose meters for the management of diabetes with
automatic linkages to an implanted insulin pump that delivers insulin according to
algorithms customized for each person. This is the ultimate goal in closed loop or artificial
pancreas CGM.
The major companies in this segment, Abbott, Medtronic and Dexcom are working with
multi-generation devices to offer closed loop continuous glucose monitoring (CGM)
systems that involve, a meter (sensor), transmitter and insulin pump. These companies
compete in an exciting emerging test segment and account for some 80% of the market.
Insulin pump companies, Insulet and Tandem, have alliances with meter companies. Other
companies are entering the market with CGM products.
Diabetes screening and glucose control in diabetic individuals is now also widely
accomplished through annual or regular quantitative testing for glycated hemoglobin
(HbA1c) using immunodiagnostic or high-performance liquid chromatography (HPLC)
methods. The test can be used to assess patient diabetes risk by using HbA1c as an
indicator of long-term blood glucose concentrations (over 6-12 months).
The crude rate of cancer incidence in the United States is likely to continue rising with
demographic aging. In 2022, there will be an estimated 1.9 million new cancer cases
diagnosed and 609,360 cancer deaths in the United States. Lung cancer incidence has
declined in the United States with fewer smokers. Colon and rectal cancer incidence also
declined in the past decade, owing potentially to provider emphasis on regular screening
and removal of precancerous polyps. Prostate cancer rates have fallen due to routine
prostate cancer screening (PSA) tests. Additionally, female breast cancer incidence has
fallen in the United States.
Cancer risk screening, diagnosis, monitoring, and treatment support a robust clinical IVD
market leveraging various technologies including histology (including immunologic and
molecular tissue assays as well as digital pathology technologies), flow cytometry,
molecular assays, immunoassays, and other specialty tests. The United States is estimated

at just under half (45%-50%) of the global market for cancer diagnostics despite treating
only 5% of new cancer patients in the world each year. The emergence, commercialization
and proliferation of cancer diagnostics will significantly bolster several IVD segments.
Table 2-1: U.S. New Cancer Cases 2022 Estimates, by Type (Female Breast, Prostate, Lung and Bronchus,
Colon and Rectum, Corpus and Uterus, Melanomas of the Skin, Urinary Bladder, Non-Hodgkin Lymphoma,
Kidney and Renal Pelvis, Thyroid, and Pancreas)
Cancer Type Total New Cases Percent of Total
Female Breast 287,850 31%
Prostate 268,490 27%
Lung and Bronchus (Male) 117,910 12%
Lung and Bronchus (Female) 118,830 13%
Colon and Rectum (M&F) 151,030 8%
Corpus and Uterus, NOS 65,950 7%
Melanomas of the Skin (M&F) 99,780 6%
Urinary Bladder (Male) 61,700 6%
Non-Hodgkin Lymphoma (M&F) 80,470 4%
Kidney and Renal Pelvis (M&F) 79,000 4%
Thyroid (Female) 31,940 3%
Pancreas (M&F) 62,210 3%
Source: Kalorama Information and American Cancer Society 2022

Table 2-2 U.S. Estimated Cancer Deaths, by Cancer Type (Lung and Bronchus, Female Breast, Prostate,
Colon and Rectum, Pancreas, Ovary, Liver and Intrahepatic Bile Duct, Leukemias, Non-Hodgkin
Lymphoma, and Corpus and Uterus), 2022
Cancer Type Death Count Percent of Total
Lung and Bronchus (M&F) 192,390 21%
Female Breast 43,250 15%
Prostate 34,500 11%
Colon and Rectum (M&F) 52,580 8%
Pancreas (M&F) 49,830 8%
Ovary 12,810 4%
Liver and Intrahepatic Bile Duct (M&F) 30,520 4%
Leukemias (M&F) 24,000 4%
Non-Hodgkin Lymphoma (M&F) 20,250 3%
Corpus and Uterus, NOS 12,550 4%
Source: Kalorama Information and American Cancer Society 2022
The United States long ago implemented comprehensive and robust disease control
programs that practically eliminated several endemic infectious diseases and have since
prevented and curbed the introduction of diseases from overseas travelers and trade.
Climatic and natural environmental factors have also inhibited the spread to the United
States of certain infectious diseases endemic to tropical regions such as malaria, dengue,
and typhoid. However, the warming climate and seawaters with climate change threaten to
extend the endemic range of several vector-borne diseases into the United States and
increase rates of transmission for other diseases. Globalization and climate change
represent significant risk factors for pandemics and the emergence of new disease threats,
though these triggered events are too unpredictable to forecast in terms of market impact or
too gradual to result in substantial market impacts within the scope of this report. Overall,
infectious disease testing represents a stable U.S. market with favorable growth prospects in
higher-burden diseases such as hepatitis, HIV, hospital-acquired infections (HAIs),

emerging infectious diseases, sexually transmitted diseases (STDs), and respiratory tract
infections.
In the United States, STDs have been problematic from a public health standpoint and
sustained screening has been necessary for the elimination of certain diseases or to
otherwise reverse growing incidences. In some cases, the observed increases in STDs may
be a result of improved screening efforts rather than an actual groundswell in infections.
While truly rising STD incidence in the United States is debatable, the above trends are
nonetheless positive for the IVD industry since STD screening is becoming more
commonplace in healthcare given an ongoing emphasis upon preventative care and
improving national insurance coverage.
In the United States, individuals born between 1945 and 1965 are five times more likely to
have a hepatitis C virus (HCV) infection than any other adult age group. The recent rise in
the use of injectable drugs such as heroin has reached many demographics, including the
young – several states reported a tripling of acute hepatitis C infections. Hepatitis C
screening has become more common in response to these risk factors associated with drug
use, the long asymptomatic or mild symptoms of infection, and tests’ eligibility as
preventive services following healthcare reform. Treatment is increasingly effective, and its
implementation drives the most valuable segment of the hepatitis diagnostics market in
quantitative or viral load tests.
The incidence of HIV infection has slowly declined in the United States overall, though
testing remains robust as the bulk of the associated diagnostics market is for quantitative or
viral load tests used to monitor the state of infection during therapy and control patients’
transmission risk.
Diseases such as measles and whooping cough (B. pertussis infection) are resurgent in the
United States due to weakened immunization coverage in certain regions. Reluctance to
follow immunization schedules and failure to immunize children has led to outbreaks of
previously rare diseases for the United States. Continued resistance to childhood
immunization in some communities will strengthen the need for surveillance and
necessitate use of previously uncommon diagnostic tests. The U.S. incidence of whooping
cough or pertussis totalled 18,617 in 2019 dropping from 18,975 in 2017. Infectious disease
immunoassay and molecular assay specialists have targeted pertussis in recent years for test
product introduction in order to capture growing demand.

Foodborne illnesses – including Salmonella, Shiga-toxin producing E. coli (STEC), and

Vibrio bacteria– have been on the rise in the United States. Reasons behind the trend are
unknown, though foodborne illness is often a result of inadequate food safety or
preparation. Vibriosis or infection from Vibrio bacteria is most often associated with the
consumption of undercooked or raw shellfish such as oysters. The marine pathogen is
postulated to represent a growing risk with warming seawaters from climate change.
Arthropod vector-borne diseases such as Lyme disease, spotted fever (ticks), St. Louis
encephalitis, West Nile Virus (WNV), malaria and dengue (mosquitoes) have already
begun to rise in incidence in the United States or are a threat to extend their endemic range
within southern U.S. regions. Rocky Mountain spotted fever is a form of rickettsiosis or
infection by Rickettsia bacteria that can be transmitted to humans by tick bites. Both
spotted fever and Lyme disease, also transmitted by ticks, are becoming more common in
the United States and in the case of the latter, infections are becoming more widespread.
The diseases are able to spread to more northern latitudes with climactic warming, which
may also be linked to increased tick reproduction and increase risks of disease transmission
to humans.

Table 2-3: Reported Cases of Selected Notifiable Diseases (Arboviral Diseases [incl. West Nile], Babesiosis,
Brucellosis, Chlamydia, Cholera, Coccidiodomycosis, Cryptosporidiosis, Dengue,
Ehrlichiosis/Anaplasmosis, Giardiasis, Gonorrhea, Hepatitis A, Hepatitis B, Hepatitis C, HIV/AIDS,
Legionellosis, Listeriosis, Lyme Disease, Malaria, Meningococcal Disease, Pertussis, Q Fever, Salmonellosis,
Shiga toxin-producing E Coli, Shigellosis, Spotted Fever Rickettsiosis, Syphilis, Tuberculosis, Vancomycin-
intermediate Staphylococcus aureus, Vibriosis), U.S., 2016-2019, by Case Count
Disease 2016 2017 2018 2019
Arboviral Diseases (incl. West Nile) 247 156 N/A N/A
Babesiosis 1,910 2,368 2,160 2,420
Brucellosis 127 140 138 165
Chlamydia 1,598,354 1,708,569 1,758,668 1,808,703
Cholera 15 10 14 14
Coccidiodomycosis 11,829 14,364 15,611 18,407
Cryptosporidiosis 13,453 11,414 12,533 13,975
Dengue 903 437 424 1,414
Ehrlichiosis/ Anaplasmosis 4,151 5,762 4,008 5,655
Giardiasis 16,310 15,193 15,548 14,860
Gonorrhea 468,514 555,608 583,405 616,392
Hepatitis A 2,007 3,365 12,474 18,845
Hepatitis B 3,218 3,409 3,332 3,544
Hepatitis C 2,942 4,225 4,768 4,136
HIV/AIDS 34,775 33,938 39,999 31,723
Legionellosis 6,414 7,458 9,933 8,890
Listeriosis 786 887 864 928
Lyme Disease 36,469 42,743 33,666 34,945
Malaria 1,955 N/A 1,748 1,936
Meningococcal Disease 375 353 327 371
Pertussis 17,972 18,975 15,609 18,677

Disease 2016 2017 2018 2019
Q Fever 164 193 215 212
Salmonellosis 53,850 54,285 60,999 58,371
Shiga toxin-producing E Coli 8,169 8,672 15,996 16,939
Shigellosis 21,097 14,912 16,333 18,574
Spotted Fever Rickettsiosis 4,269 6,248 5,554 5,207
Syphilis 88,042 101,567 115,045 129,813
Tuberculosis 9,272 9,105 9,025 8,916
Vancomycin-intermediate Staphylococcus aureus 108 109 85 76
Vibriosis 1,273 2,085 2,964 2,851
Source: CDC
Another leading infectious disease threat to the United States is infections contracted by
hospital inpatients or in other healthcare settings. One out of every 31 U.S. inpatients is
estimated to contract a HAI, though not necessarily a highly virulent or deadly strain. The
CDC reports that at least 1.7 million Americans develop sepsis annually and roughly
270,000 deaths are linked to the condition. It has become one of the key points for hospitals
in assessing patient outcomes and risk as it is estimated that 1 in 3 patients who die in
hospitals have sepsis.
The most common HAIs are bloodstream infections related to central lines, followed by
catheter-associated urinary tract infections, and then surgical site infections and ventilator-
associated pneumonia. Through both funding, advising and penalties, federal regulators and
state governments have brought about a reduction of HAI events.
Hospital-acquired infections remain a significant threat for U.S. hospitals and have
commanded significant investment in terms of testing. One of the most dynamic spaces of
the U.S. IVD market has been the decentralization of molecular testing including rapid
molecular testing for HAIs and pathogen antimicrobial resistance (AMR) in hospital labs.

U.S. Clinical Lab Expenditure
Total clinical laboratory expenditure or lab test spending in the United States is estimated
by Kalorama Information at approximately $89.3 billion in 2021. Clinical laboratory
expenditure includes service revenue collected by hospital laboratories, independent
laboratories, physician office laboratories (POLs), and other health institutions whether
providing in-house or outreach (community) testing services.
Hospital labs complete the most testing in the United States with approximately $46.4
billion in testing expenditures. Independent laboratories in the United States, led by Quest
Laboratories and LabCorp, represent approximately $39.4 billion in clinical lab
expenditures. Physician office laboratories provide approximately $3.5 billion annually in
clinical testing services. Hospital laboratories claim the bulk of testing through a
combination of test flows from hospital inpatients, outpatients and outreach business or
testing services offered to third-party healthcare providers. Hospital acquisition of
physician practices and ambulatory networks has further bolstered hospital labs’ testing
volumes.
Significant pricing pressures will come to bear on hospital labs and, in turn, the distribution
of clinical lab spending across the primary lab segments. For over the past decade, hospital
labs have increased their share in U.S. clinical testing through increased outpatient business
and the acquisition of physician practices and groups. Continued growth and gain in market
share for U.S. hospital labs will increasingly be challenged by payers, physicians and
patients incentivized to seek out lower-cost testing often available through independent
labs. Opportunities for further growth in the hospital lab business are diminishing along
with available hospital acquisition targets such as physician practices. Relative to reference
or independent labs, hospital labs will be more sensitive to stagnant or cut test
reimbursement rates.
Major independent labs such as Quest Diagnostics have begun to seek out hospital outreach
businesses to regain market share. Divestitures or hospital outreach business downsizing is
anticipated to continue among hospitals in response to tightening reimbursement rates. Cost
sensitivity is already motivating some payers to craft care networks that exclude hospital
labs.

Table 2-4: U.S. Clinical Lab Market by Channel (Hospital Labs/Acute Care Labs, Independent Labs, and
Physician Office Labs/Outpatient Labs), 2021-2026 (% of Market)
Channel 2021 2026
Hospital Labs/Acute Care Labs 51.9% 52.6%
Independent Labs 44.1% 43.4%
Physician Office Labs/ Outpatient Labs 4% 4%
Clinical laboratory expenditures in the United States are met predominately through private
payments. Managed care organizations (MCOs) are responsible for approximately 40% of
U.S. clinical lab expenditures, followed by commercial insurance and other non-patient
private payers (29%); Medicare and Medicaid (26%); and patients (4%). Kalorama
Information expects payer distribution in U.S. clinical lab testing to remain largely
unchanged through 2022; the shares of the Medicare and Medicaid programs and of
patients (OOP payments) may each gain marginally (1%-2%) due to aging and as
coinsurance or deductibles become more of a factor in lab testing.
Preventive Health Care
The ACA strongly supported prevention of chronic and acute diseases that represent high
burdens in terms of health spending and national morbidity or mortality. The Act critically
established a list of preventive care services that must be covered by both publicly paid and
commercial insurance plans without patient co-payment. Additional service
recommendations are made by the USPSTF. Wellness visits or physicals are often provided
by payers free-of-charge following the implementation of the ACA, though out-of-pocket
charges can be incurred if patients initiate other treatments during the annual visit. Patient
subsets and at-risk populations are provided screening services or preventive treatment
without co-payment under services listed as “A” or “B” recommendations by the USPSTF.
Test services recommended by the USPSTF and provided by U.S. payers without cost
sharing include: urine cultures for pregnant women; BRCA gene screening for women at-
risk as indicated by family history; regular Pap smears and HPV screening every 3-5 years;
Chlamydia and gonorrhea (CT/NG) screening in sexually active women; cholesterol testing

for men (35 years and older), women (45 years and older) and those at-risk; colorectal
cancer screening (including through fecal occult blood [FOB] tests) for individuals aged
50-75 years; diabetes screening in asymptomatic pregnant women; neonatal
hemoglobinopathy screening; hepatitis B virus (HBV) screening for high-risk individuals
and pregnant women; hepatitis C virus (HCV) screening for high-risk individuals and one-
time screening of adults born between 1945 and 1965; human immunodeficiency virus
(HIV) screening in individuals aged 15 to 65 and for all pregnant women; neonatal
hypothyroidism screening; neonatal phenylketonuria screening; Rh blood typing and
antibody testing for pregnant women; and syphilis screening in pregnant women and at-risk
individuals. Over 20 clinical lab tests are provided as preventive services without co-pay.
Product Innovation from Value-Based Pricing
A key driver of IVD industry growth will be product innovation addressing value-based
pricing reforms. The law’s provisions to establish ACOs and value-based CMS payments
support the development of a healthcare system in which all stakeholders are incentivized
to improve patient outcomes per unit of cost. Many healthcare executives, including those
in the IVD industry, believe that the new value-based approach will spur innovation as
manufacturers work to introduce products that provide ever greater levels of cost-benefit.

Clinical Testing Under Medicare – Reimbursement Cuts and Market-

Based Pricing
Medicare sets pricing and coverage standards for clinical lab testing in the U.S. healthcare
market. Related to its role as the single greatest U.S. payer for IVD testing services,
Medicare serves as a benchmark for private insurers’ negotiated reimbursement rates for
medical services and procedures. Private insurers also take Medicare’s lead in coverage
decisions and setting reimbursement rates for advanced and newly introduced tests. New
laboratory test codes are generally not available for payer use until the CMS has finalized
payment rates under the Clinical Laboratory Fee Schedule (CLFS) and Physician Fee
Schedule (PFS). Contemporary U.S. payer insistence on cost controls for care and services
has intensified Medicare-comparative rate setting in Medicare and commercial plans.
Following several post-recessionary adjustments and cuts to lab payments under Medicare
fee schedules, CMS is in the process of implementing a systematic methodology to lab
payment adjustments under the Protecting Access to Medicare Act of 2014 (PAMA).
Medicare has developed as the standard for price setting and coverage decisions for esoteric
and advanced tests (many used in the diagnosis and treatment of cancers in older age). Its
status as a market reference point has also been reinforced by the continual rise in share of
its payments out of national lab expenditures. Consolidating networks and private health
insurance carriers are also seeking lab testing rates more comparable to those paid by
Medicare. Cost containment using Medicare-referenced rates has intensified with the rising
demand for advanced assays in histology and molecular diagnostics and the
decentralization of testing capabilities into hospital labs and points of care (POC). Cost
cutting under government lab fee schedules will not relent over the next five years and will
be similarly taken up by private insurers operating in competitive insurance exchange
markets and restricted from freely raising premiums.
The Medicare CLFS became operational in 1984 and replaced a previous system under
which tests were paid for on a “reasonable charge” basis set by local Medicare contractors.
The CLFS reduced previous “reasonable charge” payment rates, eliminated beneficiary co-
payments, and permitted direct billing by laboratories. Prices under the CLFS were set at
60% of previous “reasonable charge” rates and became subject to annual inflation updates.

The CLFS is comprised of rates set by local Medicare contractors for the 56 geographic
areas that existed at the time the fee schedule was enacted. Beginning in 1986, local fee
schedule rates were capped by a national limitation amount (NLA) initially set at 115% of
the median contractor rate for each test. Over subsequent years, the NLA was reduced to its
current level of 74% of the median contractor rate for each lab test. Newly introduced tests,
for which a NLA was not established before 2001, were set at 100% of the median
contractor rate. Under the CLFS, contractors pay labs the lower of the local contractor fee
schedule rate, provider’s charge or the NLA amount. Many tests paid under the CLFS are at
the NLA rate.
In practice, the CLFS has rarely afforded labs higher year-over-year reimbursement rates
for Medicare beneficiary testing. Lab test prices paid under CLFS were frozen or cut every
year between 2003 and 2015, with the exception of 2012. A test reimbursed at $10.00 in
1984 under the CLFS is today reimbursed at approximately $7.91. Medicare reimbursement
under the CLFS has been cut by approximately 67% in real (inflation-adjusted dollars)
since 1984. In other words, if consumer price index updates (CPI-U; inflation updates)
were the only factor used to determine CLFS updates, a test reimbursed at $10.00 in 1984
would be reimbursed at $24.03 in 2015 (rather than the actual $7.91). Reimbursement rates
under the CLFS have fallen in recent years due to the following reductions:
• The Multi-Factor Productivity (MFP) Adjustment – Created by the ACA, the

annually calculated adjustment factor is a measure of real output per combined unit
of labor and capital and its positive trend is used to offset consumer-level inflation.
The MFP adjustment cannot reduce the inflation adjustment (CPI) below 0%.
• Additional ACA Adjustment (1.75%) – The ACA also required annual 1.75% CLFS
reductions between 2011 and 2015
• Outstanding Legislative and Regulatory Reductions – Additional cuts to CLFS

prices were enacted through other pieces of federal legislation. The Middle Class
Tax Relief and Job Creation Act of 2012 imposed a 2% cut beginning 2013. The
Budget Control Act of 2011, or “sequester”, imposed another once-off 2% cut to the
CLFS effective through 2021.
Certain procedures under the PFS have also been subject to specific revaluation, through
primarily procedures in anatomic pathology such as biopsy collection and microscopic and
professional interpretation. Reimbursement rates for laboratory tests under the PFS have
also been constrained, and at times slashed, by Medicare’s sustainable growth rate (SGR)

formula. The formula has called for comprehensive reduction in payment rates for services
under the PFS and, as a result of the formula’s inputs, has often devalued technical services
such as lab tests in deference to “cognitive” or professional services. In other instances,
technical components of histology tests such as immunohistochemical stains and molecular
probes have seen reimbursement rates increased.
Protecting Access to Medicare Act of 2014 (PAMA)
Effective January 1, 2018, Centers for Medicare and Medicaid Services (CMS) revised
payments for clinical diagnostic laboratory tests based on median values reported during
2016 and 2017. All laboratories that have more than $12,500 in Medicare revenues from
lab services and who receive more than 50% of their Medicare revenues from laboratory
and physician services during a data collection period are required to report both private
payer rates and volume data. Payments for lab services through Medicare are maintained in
the Clinical Laboratory Fee Schedule (CLFS), and the Physician Fee Schedule (PFS). For
the three-year period after the prices are established a test price cannot be reduced by more
than 10% per year and for 2021-2023, a test price cannot be reduced by more than 15% per
year.
Table 2-5: Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2025
CDLT Rates Based on Reporting Period Reduction Cap
2020 January 1, 2017 - May 30, 2017 10%
2021 January 1, 2017 - May 30, 2017 0%
2022 January 1, 2017 - March 31, 2017 15% Delayed
2023 January 1, 2022 - March 31, 2022 15%
2024 January 1, 2022 - March 31, 2022 15%
2025 January 1, 2022 - March 31, 2022 0.0%
Source: Centers for Medicare and Medicaid.

CMS previously estimated that using a market-based system stipulated under PAMA would
resulting in savings of $390 million in the first year (2018), and $3.93 billion over a decade.
According to CMS, approximately 55% of independent laboratories and about 95% of
physician office laboratories will be excluded from reporting private payer data but the
remaining laboratories reporting account for 99% of CLFS lab spending and 92% of
physician lab spending. The regulation allows for civil monetary penalties of up to $10,000
per day for failure to report or for reporting fees incorrectly.
Among the groups opposing was the American Clinical Laboratory Association. ACLA
President Julie Khani said, "the impact would be devastating." PAMA, signed into law in
2014, establishes a market-based pricing system for lab tests where Medicare payment for a
test equals the weighted median of private payor rates. In implementing a process for
collecting the information needed to establish pricing, CMS said only "applicable labs"
could report test payment rates and volumes from private payors. From ACLA's point of
view, the simulation only further proved that CMS' approach is not inclusive of the entire
lab market. According to the HHS Office of Inspector General there are approximately
7,000 hospital labs in the US, and critics believe their exclusion distorts the total market
picture.
Companies prepared for a reduction in payments due to the changes but the results and how
they affected each company varied widely.
On December 10, 2021, the “Protecting Medicare and American Farmers from Sequester
Cuts Act was passed which delayed the reporting requirement under Section 183A and also
delayed the 15% phase in reduction.
Impact of CARES Act on PAMA
As a response to the Coronavirus at the start of 2020, US Congress passed an amendment to

the PAMA reductions scheduled for the 2021 year. This amendment includes a suspension
to the reduction of reimbursement rates. In June 2022, the 2022 CLFS was supposed to
include a PAMA-required 15% phase-in reduction in Part B reimbursements but in
December 2021, Congress passed legislation delaying application of the 15% cut for at
least another year.

In July 2022, CMS announced that the payment penalty phase for the AUC Mandate will
not begin on January 1, 2023, as previously stated. There was no update on when full
implementation would take effect.

Precision Medicine and NGS
Precision medicine is a term that was coined to mean the tailoring of drugs and testing to fit
an individual. Most medical treatments are designed for the average patient as a one-size-
fits-all approach. This has been the norm for many years. However, not everyone reacts the
same and precision medicine involves tailoring disease prevention and treatment to fit the
individual. Advances in precision medicine have already led to powerful new discoveries
and FDA-approved treatments that are tailored to specific characteristics of individuals,
such as a person's genetic makeup, or the genetic profile of an individual's tumor. Patients
with a variety of cancers routinely undergo molecular testing as part of patient care,
enabling physicians to select treatments that improve chances of survival and reduce
exposure to adverse effects.
Precision care will only be as good as the tests that guide diagnosis and treatment. Next
Generation Sequencing (NGS) tests are capable of rapidly identifying or 'sequencing' large
sections of a person's genome and are important advances in the clinical applications of
precision medicine. Patients, physicians and researchers can use these tests to find genetic
variants that help them diagnose, treat, and understand more about human disease.
The FDA is working to ensure the accuracy of NGS tests, so that patients and clinicians can
receive accurate and clinically meaningful test results. The vast amount of information
generated through NGS poses novel regulatory issues for the FDA. While current
regulatory approaches are appropriate for conventional diagnostics that detect a single
disease or condition (such as blood glucose or cholesterol levels), these new sequencing
techniques contain the equivalent of millions of tests in one. Because of this, the FDA has
worked with stakeholders in industry, laboratories, academia, and patient and professional
societies to develop a flexible regulatory approach to accommodate this rapidly evolving
technology that leverages consensus standards, crowd-sourced data, and state-of-the-art
open-source computing technology to support NGS test development. This approach will
enable innovation in testing and research, and will speed access to accurate, reliable genetic
tests.
In April 2018, the FDA issued two final guidances that recommend approaches to
streamline the submission and review of data supporting the clinical and analytical validity
of NGS-based tests. These recommendations are intended to provide an efficient and
flexible regulatory oversight approach: as technology advances, standards can rapidly

evolve and be used to set appropriate metrics for fast growing fields such as NGS.
Similarly, as clinical evidence improves, new assertions could be supported. This adaptive
approach would ultimately foster innovation among test developers and improve patients'
access to these new technologies.
The realization of a greater clinical sequencing market will depend upon a variety of factors
including the standardization in regulatory review of clinical sequencing products; the
miniaturization or downsizing of clinical sequencing systems; and technological
improvements that reduce hands-on time and automate analysis in order to reduce the risk
of user error. New sequencing tests will also be required to successfully demonstrate their
clinical utility to justify reimbursement, in terms of improved patient outcome when
coupled with a particular therapy or to predict patient outcomes that allow patients to
consider multiple care strategies. Adaptation of NGS to POC settings is still far away and
will need demonstration of significantly higher utility compared to other existing POC
platforms.
In August 2022, the FDA approved the first NGS-based companion diagnostic for NSCLC
patients with HER2 (ERBB2) activating mutations for treatment with ENHERTU. Thermo
Fisher received approval of Oncomine Dx Target Test as a companion diagnostic for
patients with unresectable or metastatic NSCLC. The test is the only NGS CDx that has
received regulatory approval and is available in 17 countries for 15 targeted therapies,
which was first approved in 2017.

Laboratory-Developed Tests (LDTs)
Once an obscure corner of the U.S. regulatory landscape for medical devices, laboratory-
developed tests (LDTs) came under scrutiny by the FDA following a proliferation of high-
profile lab-performed testing services for critical diseases. The majority of LDTs are based
on molecular diagnostic technologies including nucleic acid amplification, array-based
hybridization, next-generation (post-Sanger) sequencing, and liquid biopsies. Other
advanced LDTs known as multi-analyte assays with algorithmic analysis (MAAAs)
combine multiple results from individual biomarkers to produce a single combined result or
metric and may incorporate protein or nucleic acid targets or a combination of both.
Rising test complexity has helped transform the LDT business from one focused primarily
upon testing for rare conditions to one with now over 100,000 test services in the United
States for cancer risk assessment, cancer diagnosis, cancer therapy, non-invasive prenatal
testing (NIPT), other genetic risk assessment, infections, and post-natal developmental
disorders among other clinical areas. Even regulators are unsure as to the number of
marketed LDTs in the United States and the total mix of available services following years
of exponential growth in LDT menus.
Although valued in the billions of dollars, the U.S. LDT market is service-based and
outside the scope of the U.S. IVD market. Lab-developed tests are still relevant to a
discussion of the U.S. IVD market both as an alternative revenue source that can forestall
test development as IVD products and as a potential pipeline for diagnostic product
development. Several major IVD players such as Illumina (acquisition of Verinata), Roche
Diagnostics (Ariosa Diagnostics) and Siemens Healthcare Diagnostics (NEO New
Oncology) have acquired LDT service labs to enter high-growth areas such as NIPT or
molecular cancer testing. These acquisitions could prefigure the parent companies’
development of LDTs into a marketable platform, either as an IVD product or, as is already
the case in NIPT, a technology licensed to other labs. Other IVD companies that have
offered LDTs through company-sponsored labs or lab acquisitions include Beckman
Coulter, bioMérieux, Fujirebio, Iris International Thermo Fisher Scientific, Bio-Rad
Laboratories, Life Technologies, OPKO Diagnostics, Randox Laboratories, Sysmex, and
Standard BioTools.
The future of the LDT model as a channel for the introduction of advanced clinical
diagnostics to the U.S. market will depend upon whether additional oversight is given to

the U.S. FDA. The agency is seeking to expand enforcement and require premarket
approval (PMA), the most stringent device marketing application, for higher-risk LDTs.
The lab industry is concerned new enforcement of LDTs will harm diagnostic innovation
by removing shorter-term revenue opportunities and imposing added costs.
The FDA’s attention to LDTs has intensified over the past decade. There has been
considerable discussion in recent years about regulation of this market, and the FDA
proposed a draft guidance calling for more FDA oversight of these tests. However, at this
time, the likely outcome of this discussion is not clear. The COVID-19 pandemic has
changed the focus due to the need currently presented. However, some LDTs available
today have already been FDA cleared or approved, and others are likely to be developed
into in vitro diagnostic (IVD) tests that a company can ship widely to clinical laboratories.
Meanwhile, new LDTs are being developed and introduced, and some segments of this
market (especially the market for cancer diagnosis, prognosis, personalized medicine, and
monitoring patients) have become very competitive. Some companies will not survive, but
there are also examples of successful companies. This field has attracted considerable
interest from investors and from companies making acquisitions. This is a rapidly moving,
highly dynamic market.
In September 2020, the FDA was directed by the U.S. Department of Health and Human
Services (HHS) to drop its pursuit of regulation of LDTs. Both the ACLA and the
Association for Molecular Pathology backed the move of HHS. HHS stated that the move
is a part of their ongoing department wide review of regulatory flexibilities enacted since
the start of COVID-19. There continues to be mixed responses to this HHS move. Critics
are concerned that this could negatively impact the accuracy of individual labs’ tests,
allowing unreliable tests to come to market.
Changes Resulting from COVID-19 Pandemic
There has been ongoing controversy over the FDA regulation of LDTs, which spans over
40 years. Since 1976, the FDA said it could regulate LDTs, but it had decided to not
monitor them too closely. As a result, the water has been murky with regard to lab
developed tests and reimbursement. However, this did not stop clinical labs from
developing and running LDTs as long as the labs met standards set under the CLIA Act and
did not package them into kits for sale across state lines that could be performed by other
labs.

Then, COVID-19 appeared, and labs were working overtime to develop tests that would
help identify SARS-CoV-2. Labs had wanted to use testing as soon as the virus emerged in
the U.S. but needed to be sure of the regulatory situation first, causing a delay. Lab-
developed tests were critical for the crisis in late March. For instance, when media reports
in January stated that the SARS-CoV-2 virus had reached the U.S., lab professionals said
they were hesitant to launch lab-developed tests. They were unsure if the agency would
practice "enforcement discretion." Initially, Congress disfavored lab-developed tests,
excluding them from funding in early coronavirus bills and adding it in after protest from
AMP and other organizations.
AMP is a supporter of lab-developed tests and a bill introduced by Sen. Rand Paul called
the Verified Innovative Testing in American Laboratories (VITAL) Act of 2020. The
VITAL Act's main provisions work to clarify that the regulation of lab-developed tests
within the CLIA program under CMS and not the FDA, including during a public health
emergency, and defines lab-developed tests as a professional medical service, a position
that AMP has supported for many years. While the legislation was not acted on, the
American Clinical Laboratory Association, AdvaMedDx, and the Biotechnology
Innovation Organization urged Congress in a letter to finalize changes to proposed
legislation overhauling diagnostics regulation by the end of the year.
The American Association for Clinical Chemistry (AACC) urged Congress to exempt the
many national and regional clinical laboratories that are separate from the public health
system, but that also have the expertise and capacity to develop and perform coronavirus
tests. As early as 2014, the AACC warned that "too much additional FDA oversight could
prevent labs from helping underserved patient populations."
In February 2020, the FDA issued new guidance that permitted labs to develop novel
coronavirus molecular diagnostic tests and begin to use them before obtaining EUA. Thus,
making LDTs for coronavirus a welcome part of the pandemic response. Many clinical labs
speculate that this could open the door for more LDTs in the future and validate the ones
currently performed in labs around the country.
The COVID-19 pandemic highlighted some of the use of LDTs as tests emerged to detect
and assist in controlling its effects. Some renewed stirring in the industry about LDTs and
regulation are surfacing as of recently, but a formal review and action have not been
outlined by the FDA.

The first policy announcement regarding LDT from FDA was released in 2020. The 2020
policy directed FDA not to require premarket review for LDTs and CMS was tasked with
oversight under CLIA.
In 2021, there was a lack of advancement of the proposed policy of 2020.
In 2022, the debate about FDA regulation of LDTs again was addressed and again is in
limbo. In June 2022, the Senate recently attached the Verifying Accurate Leading-edge
IVCT Development Act of 2022 (VALID Act). The VALID act will take several years to
fully implement but could encourage growth in the clinical laboratory market as there will
likely be more investment opportunities. However, at the time of writing, there is no
movement in the area of LDT regulation and the debate rages on. The biggest concern is
that many industry participants have is that VALID could retard the development process
of many LDTs such as for Alzheimer’s disease because it includes a number of provisions
that are not industry friendly.

COVID-19 Impact
The impact of COVID-19 generally positive at this time. From the perspective of
conventional markets have rebounded and exceeded expectations in some areas.
In July 2021, the CDC announced that it is phasing out the Real Time PCR Test for
COVID-19. It will no longer be a valid and recognized method for determining COVID-19
infection.
After December 31, 2021, CDC withdrew the request to the U.S. Food and Drug
Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel
Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced
in February 2020 for detection of SARS-CoV-2 only.
Because of this change, laboratories began to adopt methods that facilitate detection and
differentiation of SARS-CoV-2 and influenza viruses. There has been an increasing number
of multiplex tests that differentiate SARS-CoV-2 and influenza viruses.

U.S. Healthcare Infrastructure and Testing Channels
The U.S. IVD market has several major channels or venues where diagnostics are used.
Hospitals represent the leading IVD testing channel, followed by independent laboratories,
distributed testing sites or physician office laboratories (POLs), other near patient testing
sites, and consumer at-home testing with “over-the-counter” (OTC) IVD products.
Hospitals are not expected to cede their role as the backbone of clinical testing in the U.S.
healthcare system, though trends of decentralization through IVD technology and pricing
pressures on hospital labs are expected to slightly shift the distribution of testing volumes
over the coming years. The ACA has encouraged realignment of services, expanded the
ranks of insured and redefined goals in the U.S. patient care model and thereby created
opportunities for IVD use outside of hospital settings. Accompanying the shifting
landscape of health care in the United States, IVD technology has made notable recent
advances in terms of the downsizing of testing platforms and integration of testing
procedures under one instrument hood to simplify usage and enable testing outside of
traditional laboratory settings.
Hospitals
Hospital laboratories perform approximately 55% of clinical testing by value and volume in
the United States. There are approximately 9,271 labs located at the approximately 6,093
hospitals of the United States. Hospitals feature at least a main laboratory and may also
operate additional labs in their emergency department, intensive care unit, surgical units,
and satellite sites. Hospital market share in clinical testing is largely secure through
inpatient flow, ancillary outpatient flow, and exposure to the clinical lab services market
through outreach businesses. The predominant U.S. hospital business strategy of acquiring
physician practices and groups has also allowed hospital labs to increase testing volume at
the expense of independent or private laboratories.
Significant pricing pressures will come to bear on hospital labs and, in turn, the distribution
of clinical lab spending among primary lab segments. Continued growth and competitive
share gain for U.S. hospital labs (across from independent labs) will increasingly be
challenged by payers, physicians and patients incentivized to seek out low-cost testing.
With increased cost-sharing or higher OOP payments through deductibles and coinsurance,
patients requiring tests may opt for independent lab testing over hospital outreach testing

when it is available. In cases of bundled payment models for care, physicians will also seek
lower-cost testing venues in order to maintain margins on capped payments. Commercial
health plans have already begun crafting care networks that exclude hospital labs with
higher per-test prices. In this environment, independent labs are projected to compete more
effectively with hospital labs as additional testing volume is added to the U.S. market, but
with greater payer attention on lab test costs.
Independent Labs
Independent laboratories or privately-owned, stand-alone clinical labs provide testing

services to a diverse set of payers in the United States and earn approximately $39.4 billion
in annual revenue. There are approximately 9,570 CLIA-certified independent labs in the
United States that manage an estimated annual volume of approximately 5 billion tests. The
independent lab industry averages higher revenue per test through an acquisition and
business development strategy focused on molecular and other esoteric testing with fewer
competitors. Even hospitals represent clients for independent labs in high complexity and
other low volume specialty testing.
Large independent labs competed well and gained market share in the previous decade
through advantages in contracting with national managed care organizations; efficient,
centralized billing management; lower supply costs (able to negotiate large orders with IVD
vendors); comprehensive testing capabilities; and the ability to readily invest in new lab
technologies. A notable surge in lab acquisition took place in the United States between
2004 and 2011 in terms of transaction volume. Large independent labs focused on building
strengths in molecular and specialty testing by acquiring smaller outfits. Anatomic
pathology groups also saw consolidation by urban market and related to hospital
consolidation. National anatomic pathology group labs emerged late last decade as major
independent labs such as Quest and LabCorp also began acquisitions in the same clinical
area.
The U.S. independent lab sector is expected to increase competitiveness with hospital labs
and in terms of overall growth. National and large regional clients will favor the lower test
costs and network capabilities of large independent lab groups. Independent labs will also
lead in the high-growth molecular and other specialty testing markets, including advanced
histology assays. The enactment of PAMA will also skew market pricing and demand
towards lower-cost testers such as reference labs.

Physician Office Laboratories
Physician office laboratories nearly outnumber all other certified clinical labs combined in
the United States at over 133,062 locations but are dwarfed by independent labs and
hospital labs in terms of testing volume. The majority of POLs are certified to only perform
CLIA-waived tests (low complexity testing with minimal risk of error) or provider-
performed microscopy (PPM). Less than 20% of POLs are certified to perform CLIA
moderate and high complexity testing.
The U.S. POL IVD market is attractive with a growth rate above that of the overall U.S.
IVD market (~4% annually) and an appreciable size at over $3.5 billion. Physician office
testing menus are expected to continue growing with the addition of CLIA-waived IVD
products including molecular diagnostics. Also contributing to U.S. POL market growth are
the rising test volumes consistent with remaining CLIA-certified POLs upgrading of
capacity and capabilities.
At-Home Testing
At-Home testing has blossomed in the COVID-19 age. COVID-19 has demonstrated how
IVD tests can be safely and easily made available to consumers. Glucose testing has been
the mainstay of at-home testing followed by pregnancy testing both showing exemplary
track records. However, other at-home tests have been slow to be utilized. COVID-19 has
changed that as more consumers become confident with doing at-home tests. One of the
biggest barriers for the acceptance of some at-home tests was the reluctance to stick
themselves to provide a blood sample. However, with advancements in sample testing,
other methods have provided acceptable alternatives. The increased interest and money in
at-home testing will make a huge difference for smaller companies as well as larger
companies. Price is still a competitive factor but as technology and competition move
ahead, prices will drop.
Home Collection Trend
Home collection of a specimen and sending it to the lab for analysis was limping along
until COVID-19. The market was experiencing a growing trend in home collection
preferences by consumers for STDs, lyme disease, fecal occult blood testing, food
intolerances, hormone tests, sperm analysis kits for fertility, ovulation, HbA1c, heavy

metals and many other areas but it was very small. The market will continue to grow
despite the slowing of COVID-19 home collection volumes. The swelling acceptance of at
home collection is validated through the growing test menus and in some global markets, it
has expanded the screening compliance, such as in HPV and colorectal screening programs.
Retail Clinics
Retail clinics or convenience clinics offer patients routine and basic health services such as
treatment for common illnesses, screenings, and immunizations. Retail clinics are
commonly located in a drugstore, supermarket, or other mass merchandiser. The over 2,000
retail clinics in the United States provide services to roughly 19 million patients each year.
Alongside some other ancillary testing venues discussed in the next section, retail clinics
represent an emerging, though still minor client channel for IVD vendors.

Conclusions
The following are among the main conclusions of this chapter and inform the market
projections provided in the following chapter:
• Demographic aging is one of the primary market drivers for IVD in the United
States in 2022. Aging is associated with rising incidences and rates of prevalence
for several non-infectious diseases including diabetes and cancer. Individuals over
the age of 60 are estimated to average at least four times the number of clinical tests
of younger individuals.
• Although not associated with infectious disease testing due to effective controls and
non-conducive climate, the United States has several major infectious disease
testing market opportunities including HIV, other STDs, hospital-acquired
infections, and respiratory infections.
• The composition of payers in U.S. health expenditure is shifting with losses in

group plan enrollment following the implementation of the ACA; Medicaid
eligibility is expanded due to the legislation; and aging increases the number of
Medicare beneficiaries. Aging and Medicaid expansion under the ACA are expected
to drive growth in clinical testing paid for under the two CMS-affiliated programs
above the rate of growth in private payer spending. Out-of-pocket spending
continues to be marginalized in clinical testing despite the prevalence of copayment
requirements.
• Hospitals perform the majority of clinical testing in the United States both in terms
of value and volume. Hospital labs are active not only in internal patient testing but
also third-party testing through outreach services. Hospital acquisition strategies and
the proliferation of outreach businesses have allowed hospital labs to gain market
share across from independent private labs. The latter lab segment has regained its
past market competitiveness due to independent labs’ cost advantages related both
to scale and advanced testing capabilities.
• COVID-19 had a profound effect on the U.S. Healthcare Infrastructure and Testing
Channels. Molecular tests grew substantially and POC tests for infectious disease
soared.

Chapter 3: U.S. IVD Market Analysis
This chapter discusses the following IVD market segments in the United States:
• Clinical Chemistry
• Microbiology (Traditional) – Identification and Antibiotic Susceptibility Testing

(ID/AST)
• Microbiology – Molecular- Infectious Disease
• Point-of-Care (POC) Tests – Diabetes
• Point-of-Care (POC) Tests – All Other
• Immunoassays – Infectious Disease (non-POC)
• Immunoassays – Other
• Molecular - Non-infectious Disease
• Hematology
• Coagulation (non-POC)
• Histology
• Blood Testing and Typing
• Others
Larger U.S. IVD market segments are further segmented by testing subcategories. Market
sizes represent manufacturer-level revenue and are estimated for 2022 and forecast to 2027.

Clinical Chemistry
The bulk of clinical chemistry testing is performed in the core lab at workstations alongside
immunoanalyzers and as part of immunochemistry combined platforms. Routine clinical
chemistry panels comprise 30 to 40 tests including substrates, metabolites, blood gases,
enzymes, and lipids. Renal clearance, liver function and metabolic status also factor in
clinical chemistry testing. Core lab chemistry stations also perform tests for blood gas and
electrolyte levels that are routine in cases of admitted and hospitalized patients. The market
segment discussed in this section does not include point-of-care (POC) chemistry tests
completed using portable or handheld analyzers.
Clinical chemistry is an established segment in the U.S. IVD market with the majority of
the market consolidated among a handful of major players:
• Roche Diagnostics,
• Siemens Healthcare Diagnostics,
• Abbott Diagnostics,
• Danaher
The U.S. clinical chemistry market is estimated at approximately $3.5 billion (2022) and is
projected to grow at a compound annual growth rate of approximately 1.1% through 2027
to reach nearly $3.7 billion.
Table 3-1: U.S. Clinical Chemistry Market (General Chemistry, Blood Gases, and Urinalysis) 2022-2027 (in
millions $) est
Segment 2022 2027 CAGR %
General Chemistry 2,681 2,788 0.8%
Blood Gases 418 469 2.3%
Urinalysis 382 413 1.6%
Total 3,481 3,671 1.1%

Figure 3-1: U.S. Clinical Chemistry Market, 2022-2027 ($ millions)
Provider consolidation in the United States, commoditization of most chemistry offerings

and pricing pressures on testing services has pushed the cost per test of routine chemistries
just about as low as possible.
This mature industry is continuously trying to reinvent itself by improving test processes
and test menus. Trends in clinical chemistries over the next 5-10 years include:
• new emerging tests, including markers for metabolic and cell pathways
• a reorganization of testing procedures
• emphasis on increasing whole blood analysis
• workstation consolidation
• expansion of automated solutions

Microbiology and Virology – ID/AST and Molecular
The U.S. IVD market for microbiology and virology includes traditional microbiology
(culture-based identification and antimicrobial susceptibility testing [ID/AST]) and the
dynamic space of molecular or nucleic acid-based testing for pathogen identification and
characterization. Molecular technologies have reduced microbiology testing turnaround
times from as long as a week to, in some cases, only hours. Molecular microbiology and
virology testing is increasingly prevalent throughout clinical settings. Supported by CLIA
moderate-complexity and CLIA-waived tests, molecular tests can now be performed
outside centralized labs in hospital labs and even near-patient testing at the point of care.
Microbiology testing using ID/AST reagents and systems is accomplished using a variety
of samples including blood, urine, and body fluid and swabs from wounds, post-surgical
dressing and sutures, urogenital and respiratory sites. The most-time sensitive ID/AST
workups are done on urine, wound, aspirate and blood samples from hospitalized patients
with suspected hospital-acquired infections or sepsis. Outpatient samples, which make up
some 85% of the workload, include respiratory samples tested for throat and lung
infections, urogenital samples for STDs, and urines for urinary tract infections.
Approximately 60% of microbiology specimens originate from what are expected to be

sterile sites or samples - urine, blood, cerebrospinal fluid (CSF), and other biological fluids.
It is estimated that 80% of urine samples, 99% of CSF samples and 95% of blood cultures
test negative, thus consuming a considerable number of resources in terms of instrument
capacity and labor. Shortened testing and turnaround times are highly desirable for ID/AST
systems in order to catch critical inpatient infections and achieve savings in terms of
infection control and labor.
Depending on the laboratory, blood or urine is the most common sample for culturing.
Increasing prevalence and vigilance against nosocomial bloodstream infections will sustain
blood culture volumes also used to detect sepsis risk. The high degree of difficulty in
culturing STDs is eroding the role of urogenital cultures; sexually transmitted infections are
increasingly tested for using immunoassays and molecular tests.

Table 3-2: US ID/AST Microbiology ID/AST Market (ID/AST Auto, ID/AST Panels, Blood Culture,
Chromogenic Media, and Rapid Micro) 2022-2027 ($ millions)
Segment 2022 % 2027 % CAGR %
Auto ID/AST Systems $560 31.5% $693 33.2% 4.4%
Manual ID/AST Systems $142 8.0% $149 7.2% 1.0%
Blood Culture $369 20.8% $437 20.9% 3.4%
Chromogenic Media $419 23.6% $501 24.0% 3.6%
Rapid Micro $285 16.0% $308 14.8% 1.6%
Total $1,775 100.0% $2,089 100.0% 3.3%
Figure 3-2: U.S. ID/AST Microbiology Market (Auto ID/AST, Manual ID/AST, Blood Culture, Chromogenic
Media, Rapid, Micro) 2022-2027 ($ millions)

The traditional microbiology market focuses on microbial identification followed by

antibiotic susceptibility testing (ID/AST). This traditional area of microbiology remains a
gold standard for infectious disease confirmatory testing and its growth will persist with
ID/AST’s advantages in terms of accommodation of high testing volumes and relatively
low testing costs.
The approximate $1.8 billion U.S. market for ID/AST includes the following subsegments:
• Automated ID/AST – the developed world overwhelmingly uses automated ID/AST

systems for improved throughput including faster turnaround times and less hands-
on-time; major U.S. vendors include:
o bioMérieux (VITEK),
o Beckman Coulter (MicroScan),
o Thermo Fisher Scientific (Trek Diagnostic Systems Sensititre)
o BD Diagnostics (Phoenix)
• Manual ID/AST – the U.S. market for hands-on and semi-automated systems is
relatively minor
• Blood Culture – the blood culture market is dominated by:

o Becton Dickinson (BD; BACTEC Blood Culture System);
o bioMérieux (BacT/ALERT)
Demand is related to bloodstream infections (BSIs) in hospitalized patients
• Chromogenic Media – pathogen identification can be accomplished using

fluorogenic and chromogenic substrates that react in the presence of a particular
genus or species in the culture or cultured sample; no one company dominates the
chromogenic media market; commonly supported pathogens on chromogenic media
include hospital-acquired infections (HAIs) and enterics
• Rapid Tests - these manual tests are performed in tubes or on slides from colonies
picked from growth media or swabbed plates; major players in this segment include:
o BD Diagnostics
o Thermo Fisher Scientific through its subsidiaries Oxoid and Remel

Manual and semi-automated ID/AST are expected to become increasingly marginal tools in
U.S. clinical microbiology, accounting for 8% of the market in 2022, declining to 7.2% by
2027. Automation has greatly improved ID/AST by speeding up the process with more
sensitive detection methods (shorter culturing requirements) and enabling hands-off sample
or culture preparation. Innovations such as Copan Diagnostics Liquid Based Microbiology
(LBM) improved the integration of swab-based samples within automated ID/AST
workflows. Additionally, automated modules are available for plate preparation, incubation
procedures, reagent application, and ID/AST results analysis through digital imaging. The
LBM liquid media were the basis for creating a flexible process of automation and the
Walkaway Specimen Processor (WASP).
Blood culture tubes and incubation systems are used to detect sepsis and support
mycobacterial testing for tuberculosis (TB). Blood culture tests are usually performed on
hospitalized patients that have persistent fever of an unknown origin or when sepsis is
suspected. The high burden of sepsis in hospital mortalities has also sustained sales of
blood culture systems.
Positive blood cultures have been a target for the development of sensitive and rapid
identification testing. Numerous identification assays have been developed for use with
positive blood cultures. Multiple technologies including (fluorescent) in situ hybridization
([FISH), multiplexed PCR and mass spectrometry are finding use as highly specific and
rapid testing options. The vibrancy of the blood culture identification test space is a positive
indicator for at least the short-term health of the blood culture market within ID/AST.
As the fight to limit HAIs intensifies in the United States, selective media has been adopted
as a complementary tool. Selective media for methicillin-resistant S. aureus (MRSA)
provides test results in less than 24 hours compared to 36-48 hours with traditional ID/AST.
The accuracy and speed of molecular tests has won many clients in HAI testing, but
molecular tests have yet to roundly push microbiology cultures out of the market. Selective
chromogenic media can cost only $5 per plate test compared to molecular test kit prices of
at least $25.
Many of these rapid manual tests used for culture identification have been replaced by
analyzer-based immunoassays in developed countries but remain important tools for small
labs and in developing regions. The major players in this segment are BD Diagnostics and
Thermo Fisher Scientific through its subsidiaries Oxoid and Remel. Additional market
players include Prolab Diagnostics, Meridian Diagnostics, and Unipath. Offsetting lost

market share to immunoassays performed directly with patient samples, the emergence and
re-emergence of serious healthcare- and community-based pathogens – including C.
difficile, STDs and respiratory pathogens – continues to provide market applications for
rapid tests.
The breakthrough of molecular diagnostics was expected to presage the marginalization

and replacement of traditional ID/AST in infectious disease testing. Such a process has
played out more slowly than originally anticipated and ID/AST is expected to remain a
growth market through 2027. The projected obsolescence of culture ID/AST methods was
predicated on their long turnaround times (a day to several weeks), high demands on lab
personnel, and the superior accuracy of molecular assays. However, molecular assays are
also more expensive than ID/AST reagents and supplies and more costly to perform
compared to high throughput, automated ID/AST systems. In particular, critical, or time-
sensitive microbiology workups such as inpatient infections, ID/AST has lost market share
to molecular and other alternative rapid methods that enable clinicians to initiate targeted
treatment more quickly.
In 2020, molecular infectious disease market soared due to the COVID-19 pandemic.
COVID-19 tests were being EUA authorized almost daily by FDA, supporting revenues.
Molecular respiratory tests were also growing due to increased testing to rule out other
respiratory infectious diseases. Most other infectious diseases were down slightly in 2020
due to lockdowns and patients not accessing medical care. It is anticipated that most all
molecular infectious disease segments will return to growth in 2022 and continue
throughout the forecast period.

Table 3-3: U.S. Molecular Infectious Disease, Market Distribution Estimates by Segment (HAI/Sepsis, HIV,
Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Molecular including Parasitology,
Mycology, Malaria, Chagas, Dengue, etc.), 2022-2027 (%)
Segment 2022 % 2027 %
Molecular HAI (c.diff, sepsis, MRSA, VRE, others) 12.8% 17.0%
Molecular HIV 4.5% 5.8%
Molecular Hepatitis 10.2% 14.1%
Molecular GC/Chlamydia 2.8% 3.3%
Molecular Respiratory (including COVID-19) 65.5% 54.7%
Molecular Mycobacteria/TB 1.1% 1.6%
Molecular Other Microbiology 3.1% 3.5%
Total Molecular Infectious Disease 100% 100%

Figure 3-3: U.S. Molecular Microbiology / Virology Market Distribution Estimates by Segment, (HAI, HIV,
Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Microbiology), 2022 (%)
The diffusion of molecular diagnostics into near-patient and POC testing spaces has
occurred at a time when core labs have also their strengthened molecular capabilities. In the
United States. Infectious disease testing for now is the leading application of molecular
diagnostics by market size; roughly 15%-20% of the molecular diagnostics market is
represented by oncology and genetic testing.
The U.S. molecular diagnostics market for infectious diseases is projected to show a
decline due to retracting COVID-19 market, from approximately $7.3 billion in 2022 to
$6.1 billion in 2027, (-3.5%). Growth areas in U.S. molecular diagnostics include HAI,
hepatitis, mycobacteria/TB, and HIV.
Hospitals have invested heavily in HAI surveillance, control, and clinical testing solutions
for over the past five years in an effort to contain costs. The decentralization of testing for
HAIs and BSIs, including AMR detection, has been the principal driver behind a U.S.

molecular diagnostics market valued by Kalorama Information at $936 million in 2022.

The market leader in molecular AMR/HAI tests is Cepheid (Danaher) with Becton,
Dickinson & Co. (BD) also highly visible in the U.S. market space. The BioFire
Diagnostics (bioMérieux) FilmArray system also represents a notable market addition in
the past few years; the moderately complex molecular panel system screens symptomatic
patients and at-risk inpatients with its Gastrointestinal (GI) (including C-diff) and Blood
Culture Identification (BCID) (including VRE and CRE) Panels.
Molecular tests were not common historically in flu testing, but due to their sensitivity and
the new technologies, there has been an uptake. Kalorama has estimated an increased
market for the U.S. molecular respiratory infections (excluding COVID-19) market at $826
million in 2022.
For the 2022 year, COVID-19 infections resulted in continued demand for testing for other
respiratory diseases to confirm and rule-out COVID-19 infections. Major vendors reported
that the segment produced above average revenue growth in flu testing for 2021 and
slightly lower for 2022. Over the past couple years, major vendors have noted an increase
in system installations with severe influenza seasons or testing demands from the previous
year.
Predictions from the past decade that molecular or nucleic acid-based tests would widely
replace immunoassays in infectious disease testing have proven incorrect or at best
premature. Immunoassays remain indispensable to major testing markets for HIV, hepatitis,
and STDs. And, more recently the COVID-19 testing market is highly driven by
immunoassay technologies, with the lab-based immunoassay market worth roughly $2.3
billion in 2022. Though not as widely able to address AMR testing, immunoassays can still
be used to screen against well-defined resistance mechanisms or proteins behind methicillin
and beta-lactam resistance.
Leading trends in molecular infectious disease testing include:
• Integration of nucleic acid amplification assay processes from sample to results

within automated systems that improve productivity and widen the addressable
market in terms of client labs and testers
• Random access sample processing on instrumentation to match capabilities of core

lab immunoanalyzers and to provide more actionable results from each sample

• Simplification or elimination of hands-on sample preparation and extraction using

instrument automation and isothermal amplification methods
• Assay menu and market development will be lead by HAIs (C. difficile, MRSA,
vanA/B, CRE) and other critical infections (community- or healthcare-acquired
infections such as CMV, meningitis, encephalitis); sexual health and women’s
health (Chlamydia, gonorrhea, HPV, Trichomonas vaginalis, HSV, GBS, vaginitis);
respiratory pathogens (influenza, RSV, strep A, pertussis); emerging disease threats
and virology testing in the developing world (HIV, hepatitis, viral load testing, TB,
Ebola); and gastrointestinal pathogens (norovirus, enteric parasites, Campylobacter
spp., C. difficile, Salmonella, Vibrio, E. coli/Shigella)
• The incorporation of molecular diagnostic or nucleic acid elements in next-

generation ID/AST systems include the development of new molecular assays with
expanded target gene panels; next-generation sequencing (NGS) assays for the
determination of genotype and resistance; and other proprietary technologies
incorporating mass spectrometry (Abbott Diagnostics’ IRIDICA) or nucleic acid
probes (Roche Diagnostics’ GeneWeave Smarticles platform)
• Syndromic or disease group-organized multiplex molecular panels for the rapid

diagnosis of critical infections and illnesses to inform effective patient care
including antimicrobial therapy
• Molecular vendor targeting and penetration of expansion markets among hospital

labs, hospital POC testing sites, outpatient testing sites, POLs, and distributed
testing sites in the developing world.

Point-of-Care Testing
Diagnostic tests performed outside of laboratories or at decentralized locations near patients

are generally known as point-of-care (POC) tests. The definition also encompasses some
decentralized moderate-complexity U.S. labs such as physician office laboratories (POLs)
that perform tests near the patient and are capable of communicating the results during the
visit or within the same day. Over the years, the proliferation of transportable, portable, and
handheld instruments as well as easy-to-use immunoassays and even molecular test kits has
supported the migration of testing from the laboratory environment to a range of medical
environments including the physician office; clinic, including convenience clinic;
workplace; home; disaster care; and within hospital triage and critical care. In the United
States, regulatory easing through Clinical Laboratory Improvement Amendments (CLIA)
waivers for test products has permitted a wide range of personnel and even consumers to
purchase and perform diagnostic tests with minimal or no certification or training.
The U.S. POC diagnostics market is characterized by two principal subsegments: consumer
or over-the-counter testing (OTC) diabetes testing or self-monitoring of blood glucose
(SMBG), pregnancy and COVID-19; and other POC diagnostics products used by medical
and clinical personnel in a CLIA-waived or moderate complexity lab. The U.S. other POC
diagnostics market is segmented in this report by primary test groups.
Other POC diagnostics have seen healthy market growth in the United States. Excluding
POC infectious disease, the market is expected to increase by 5.6% to reach roughly $16.3
billion by 2027. Growth in some POC subsegments is projected to be relatively
unremarkable such as pregnancy tests (hCG) and urine tests. Dynamic product segments of
other POC diagnostics include fecal occult blood (FOB) and cardiac markers; expected to
grow at roughly 8% and 6%, respectively through 2027.
Growth in the U.S. FOB test market is based on the transition to more accurate and higher-
priced fecal immunochemical tests (FITs). Sales of lipid, tumor, and cardiac marker POC
tests in the United States are related to the mounting national burden of cancer,
cardiovascular disease, and the disease’s engagement in primary and emergency care.
Growth in the U.S. POC infectious disease test market will result from the introduction and
market penetration of molecular POC tests for infections such as COVID-19, influenza,
strep A, CT/NG, HPV, herpes simplex virus (HSV), BSIs, and HAIs. In some cases,

significant value is added by molecular POC diagnostics to the POC diagnostics market
through the replacement of lower-priced rapid immunoassay tests.
Table 3-4: U.S. Point-of-Care (POC) Diagnostics Markets (Glucose, Blood & Electrolytes, Coagulation,
Cardiac Markers, Drugs of Abuse, Pregnancy & Fertility, Fecal Occult Blood, Infectious Disease, Lipid,
Cancer Tumor Markers, Urine, Miscellaneous), 2022 and 2027 ($ millions)
Segment 2022 % 2027 % CAGR %
Glucose inc HbA1c, CGM 8,617 41.8% 11,502 50.6% 6%
Blood & Electrolytes 791 3.8% 982 4.3% 4%
Coagulation 366 1.8% 395 1.7% 2%
Cardiac Markers 326 1.6% 444 2.0% 6%
Drugs of Abuse 309 1.5% 332 1.5% 1%
Pregnancy & Fertility 513 2.5% 556 2.4% 2%
FOB 1,200 5.8% 1,749 7.7% 8%
Infectious Disease 8,193 39.7% 6,410 28.2% -5%
Lipid 142 0.7% 157 0.7% 2%
Cancer Tumor Marker 49 0.2% 58 0.3% 3%
Urine 71 0.3% 76 0.3% 1%
Miscellaneous 36 0.2% 51 0.2% 7%
Total 20,613 100.0% 22,712 100.0% 2%

Figure 3-4: U.S. POC Diabetes Market, 2022-2027 (in millions $)
Figure 3-5: U.S. POC Market without Diabetes, 2022-2027 (in millions $)

Immunoassays
Immunoassays have become one of the primary and indispensable tools in the diagnosis
and monitoring of disease due to their wide applicability in the detection and quantification
of protein analytes. Immunoassay technology supports two primary segments –
immunoassays for infectious disease detection (either through the targeting of pathogen-
specific antigens or patient antibodies) and for non-infectious diseases and medical
conditions. Market sizes for immunoassays introduced in this section do not include POC
immunoassays.
Most immunoassays have been centralized and commoditized on analyte panels run on core
lab integrated chemistry analyzers or immunoanalyzers including assays for thyroid
function, drugs of abuse, therapeutic drugs, anemia, fertility, anemia, infectious disease
(antigens or antibodies), and protein biomarkers related to diabetes, cancer, and
cardiovascular health. Additional laboratory immunoassays – enzyme immunosorbent
assays (EIA/ELISA) and other single-test formats – represent the remainder of the market
discussed in this section.
Non-Infectious Disease Immunoassay
Non-infectious immunoassay market growth in the United States is expected to proceed at

approximately 3.4% per year. Discovery of new protein biomarkers in proteomic research
has proven to be a slow pipeline with few newly developed assays in recent years. The
fastest growing test segments in non-infectious disease immunoassays through 2027 are
projected to be HbA1c (5.1% CAGR), cardiac markers (4.6% CAGR) and tumor markers
(4.2% CAGR)
• HbA1c markets have emerged as an important diagnostic measure in monitoring

diabetes patients.
• Cardiac markers continue as an area of innovation in protein biomarker

development in order to more accurately assess heart failure and heart attack risk.
• Tumor markers are growing due to advancements in technology for testing with
higher sensitivity and specificity.

Table 3-5: U.S. Immunoassays Market – Non Infectious (Cardiac Markers, Tumor Markers, Autoimmune,
Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D, HbA1c, others) 2022-2027 ($
millions)
Segment 2022 % 2027 % CAGR
Cardiac Markers $627 13.7% $784 14.5% 5%
Tumor Markers $523 11.4% $641 11.8% 4%
Autoimmune $351 7.7% $425 7.8% 4%
Allergy $228 5.0% $251 4.6% 2%
Thyroid $249 5.4% $283 5.2% 3%
Proteins $469 10.3% $537 9.9% 3%
Anemia $187 4.1% $201 3.7% 1%
Fertility $179 3.9% $197 3.6% 2%
Therapeutic Drugs $231 5.1% $268 5.0% 3%
Vitamin D $134 2.9% $149 2.7% 2%
HbA1c $456 10.0% $583 10.8% 5%
Others $941 20.6% $1,093 20.2% 3%
Total $4,576 100.0% $5,412 100.0% 3%

Figure 3-6: U.S. Immunoassay-Non-infectious (Cardiac Markers, Tumor Markers, Autoimmune, Allergy,
Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D, HbA1c, others), 2022-2027 (in millions)
$)
Infectious Disease Immunoassay
Immunoassay testing for infectious disease has advantages over culture microbiology in
terms of time to test results and ability to assay viral pathogens and over molecular
diagnostics in terms of cost. Immunoassays are widely used for the detection of infections,
patient immune status, and quantitation of viral loads in the cases of hepatitis and HIV. In
2022, the U.S. immunoassay market for infectious diseases is valued at approximately $8.3
billion, of which COVID-19 testing accounts for roughly 28% and is projected to reach
$8.8 billion in 2027.
Sepsis biomarkers are included in this market segment. Immunoassays and molecular
assays detecting pathogen analytes are not suitable for the general detection of sepsis or
assessing the severity of the syndrome. Rather, immunoassays targeting patient-produced
biomarkers (immune system proteins) have been developed for such applications.
Additionally, surface proteins expressed by immune system cells in response to sepsis can
be assayed using flow cytometry. The prohormone procalcitonin (PCT) was discovered 15

years ago to be a biomarker for systemic bacterial infections. In response to bacterial

infections, nearly all body tissues, especially lungs, release PCT. Thermo Fisher
Scientific’s acquisition of German biomarker assay specialist B.R.A.H.M.S. in 2009 also
gave it a leading position in the sepsis biomarker assay market. B.R.A.H.M.S.’s PCT
biomarker assay is considered the gold standard in European markets for sepsis diagnostics
and is also FDA-cleared.
Additional biomarkers can offer greater specificity in the diagnosis and monitoring of
sepsis including pro-inflammatory cytokines such as IL-6; other proteins expressed in
response to infection like C-reactive protein (CRP); markers of active neutrophil immune
cells like CD64; and even novel biomarkers for the immunodeficient phase of sepsis that
are also known as immunosuppression biomarkers. Innovation in the development of sepsis
biomarkers is expected to contribute to growth of the HAIs and sepsis test segment of the
U.S. immunoassays market.
Table 3-6: U.S. Immunoassays Market – Infectious (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis,
Others), 2022-2027 (in millions $)
Segment 2022 % 2027 % CAGR
Hepatitis $766 9.2% $1,086 12.3% 7%
HIV $512 6.2% $604 6.9% 3%
STDs $403 4.8% $494 5.6% 4%
ToRCH $360 4.3% $431 4.9% 4%
Respiratory (including COVID-19) $3,155 37.9% $2,604 29.5% -4%
HAIs/Sepsis $734 8.8% $1,132 12.8% 9%
Others $2,387 28.7% $2,464 28.0% 1%
Total $8,315 100% $8,813 100% 1%

Figure 3-7: U.S. Immunoassay Infectious Disease (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAI/Sepsis,
Others), 2022-2027 (in millions $)
In the United States, STDs have been problematic from a public health standpoint and
sustained screening has been necessary for the elimination of certain diseases or to
otherwise reverse growing incidences. Most cases of syphilis worldwide are outside of the
United States. The CDC estimates that 35,300 people in the United States get syphilis each
year. In addition, the U.S. Preventive Services Task Force recommends that all pregnant
women be screened for syphilis infection.
With consistent national reporting, it has become apparent that STDs have rebounded from
reported historical lows and been resilient to eradication goals.
Because of these considerations, STD testing is an area of priority for innovations. In

December 2016, Roche was awarded the CE-IVD mark for the cobas CT/NG test to detect
and distinguish Chlamydia trachomatis and Neisseria gonorrhoeae on its cobas 6800/8800
Systems. According to Roche, it is the first test to receive claims for anorectal and
oropharyngeal samples. The expanded claims are in addition to those for male and female
urine specimens, endocervical swab specimens, clinician-collected and patient self-
collected vaginal swab specimens, and cervical specimens collected in PreservCyt Solution.

In January 2018, Roche was awarded the CE-IVD mark for the cobas TV/MG test for use
on the cobas 6800/8800 molecular systems. The test allows for the direct detection of
Trichomonas vaginalis and/or Mycoplasma genitalium DNA in symptomatic as well as
asymptomatic patients. Roche said that by coupling cobas TV/MG with recently the cobas
CT/NG, laboratories can simultaneously process, from a single patient sample, any
combination of CT, NG, TV, and MG.
Coriell Life Sciences launched a solution for the quantitative diagnosis and reporting of
bacterial vaginosis. Coriell, together with Quantigen, developed the assay and a reporting
algorithm that runs on Thermo Fisher Scientific's real-time PCR-based OpenArray
technology. The solution provides affordable and comprehensive sample analysis with
rapid turnaround times, allowing Coriell to report which microorganisms are present and at
what quantities. The test aids in the differential diagnosis of other vaginal infections that
clinically present with the same signs and symptoms as bacterial vaginosis.
Several viruses can cause hepatitis including hepatitis A virus (HAV), hepatitis B virus
(HBV), hepatitis C virus (HCV), Hepatitis D virus (HDV), hepatitis E virus (HEV), and
hepatitis G virus (HGV). The most common types in the United States, and the focus of
much of the hepatitis immunoassay testing, are HAV, HBV, and HCV.
Hepatitis C remains a significant challenge for the medical community. According to the
CDC, around 3.9 million people in the United States have a chronic HCV infection or
nearly 1% of the population. An estimated 2 million people in the United States have a
chronic HBV infection.
COVID-19 testing will slow; however, antigen and serology tests will continue to be
important to determine if an individual has an active virus or immunity to the virus.

Molecular Non-Infectious Disease Diagnostics
Molecular diagnostics is a fast evolving and dynamic field. It has become an indispensable
tool in clinical medicine that touches all aspects of healthcare including treatment decisions
in terms of companion diagnostics assisting in the evaluation of suitability of various
cancer treatment options, pharmacokinetics or patient metabolism of drugs for HIV,
psychiatric conditions or blood thinners; cancer prognosis and therapy, organ matching,
blood safety, and the diagnosis of latent and neonatal conditions. Rather than replacing
other major IVD modalities such as immunodiagnostics, the molecular diagnostics market
has expanded by meeting clinical needs unmet or never envisioned with other major testing
disciplines. As they become more affordable, displacement of other diagnostics such as
immunodiagnostics has also occurred owing to the high sensitivity and unique insights
molecular diagnostics methods offer. Certain IVD segments have been or are in the course
of being remade worldwide through the application of molecular methods including blood
screening, POC diagnostics, cytogenetics, and tissue typing.
The primary growth drivers in the molecular diagnostics market overall, are the continued
discovery of genetic markers with proven clinical utility, the increasing adoption of genetic
based diagnostic tests, and the expansion of reimbursement programs to include a greater
number of approved diagnostic tests. The most attractive growth areas are molecular tests
for histological analyses, women’s health, organ transplant testing and oncology.
On the technology side one of the major drivers in this market is technological
advancements that result in new tests and technologies. Although PCR is one of the
standard techniques for conducting amplification reaction, the method is quite complex due
to the need for repeated thermo cycling and cooling, and it consumes more energy in the
process. As an alternative to PCR, isothermal nucleic amplification circumvents the need
for repeated denaturation and cooling as the amplification reaction occurs under isothermal
conditions. This greatly aids in the design of microfluidic chips for conducting molecular
diagnostics. It is expected that the increase in miniaturization of nucleic acid-based
diagnostics will boost the growth of the market.
These non-infectious disease testing activities support a U.S. molecular non-infectious

diagnostics market of approximately $1,826 million. The market is projected to grow by
9.7% annually through 2027 to reach $2,897 million.

Figure 3-8: U.S. Molecular Non-Infectious Disease Diagnostics Market, 2022-2027 ($ millions)
The molecular diagnostics industry is also experiencing a rapid shift toward an increase in
the process automation and integration of sample analysis in single miniaturized devices.
Miniaturization offers scope for reduced sample volume, enabling the end-user to automate
and analyze the sample.
Advancements in automation and information technologies (IT) have created a new level of
optimism in the molecular diagnostics markets as evident from the research investments,
university spin offs, mergers and acquisitions in the segment. The holy grail for molecular
testing is the ability to load an untreated sample onto a cartridge or cassette, push start and
then come back when the test has been completed. The ‘sample-to-result’ table-top systems
fast entering the market represent an important milestone towards achieving this goal.
Some of the leading global companies focusing on offering such table-top systems include
Cepheid, Spartan, Qiagen, Hologic, GenMark, and Enigma. The investments by such
leading companies and government agencies who partner with them are pushing the
existing limits of automation and IT, facilitating fast advancement towards near-patient and
point-of-care diagnostics solutions.
Another form of blood-based cancer tests or liquid biopsies use circulating tumor cells
(CTCs) or cells which detach from a primary tumor and circulate throughout the

bloodstream. CTCs promise to be a very valuable test for early detection of cancer and to
monitor residual disease. It is widely believed that the detection of CTCs in the blood will
become an important tool in monitoring an individual’s baseline condition and ongoing
response to therapy.
Genomic DNA amplified or sequenced from circulating tumor cells (CTCs), circulating
tumor cell DNA (ctDNA) and circulating cell-free DNA (cfDNA) harbor complementary
information on mutations relevant for the treatment of individual cancer patients. These
applications promise to impact clinical protocols and treatment regimens and will likely
determine the future standard of care in oncology.
Circulating tumor DNA (ctDNA) are small pieces of mutated DNA that tumor cells release
into the bloodstream.
Cell-free DNA (cfDNA) can be applied more broadly than ctDNA. cfDNA will determine
the standard of care in oncology, transplant medicine and cardiovascular disease. This field
is emerging as one of the most promising and exciting areas of medicine and has already
made a huge impact on prenatal care.
Researchers of circulating free nucleic acids (cfDNA) have extended the reach of this
technology beyond DNA to RNA, miRNA and exomes. Although just emerging, it is
anticipated that circulating nucleic acids may emerge as a prominent technology in future
molecular diagnostics, and so it has – first in prenatal fetal testing for genetic abnormalities
and now as the basis of the liquid biopsy in cancer.
Human leukocyte antigen (HLA) profiling, or tissue typing, is routinely performed prior to
organ or bone marrow transplantations for cancer patients. HLA testing is a key component
in determining the compatibility between potential donors and recipients in order to
maximize the chances of graft survival and prevent serious immunologic transplant
complications. The better the match of HLA types, the higher the likelihood of a successful
transplant. HLA typing has traditionally been performed using serological techniques for
immunological markers. However, this technique does not detect subtle differences
between individuals. An HLA test requires that some six genes are screened in parallel,
with each displaying about 100 important (known) local variants. This requirement lends
itself to technologies such as microarrays and sequencing that can screen for many targets.
Other non-infectious disease applications for molecular assays are relatively low growth
including testing for hereditary diseases and pharmacogenetic testing. Molecular testing is

commonly used to identify genetic roots of thrombophilia related to mutations in

coagulation factor V (Leiden variant) and coagulation factor II. Positive results can inform
anticoagulant therapy. Clinicians and pharmaceuticals have sought less testing, rather than
more, when selecting candidates for anticoagulant therapy. Other, less expensive diagnostic
options also exist when monitoring patients for safe anticoagulant therapy. Near-patient
testing for pharmacogenetic (PGx) and other hereditary conditions has limited appeal and is
not expected to develop into a major market outside of limited U.S. POL activity.
Polymerase chain reaction (PCR) and other nucleic acid amplification test (NAAT)
technologies have been used in microbiology laboratories since the 1990s, and these assays
are now widely used for a range of different pathogens.
For many years, polymerase chain reaction assays were limited to detection of a single or a
limited number of pathogens. This would mean that multiple tests might be required to
identify which pathogen has infected a particular patient. A major change in the
application of polymerase chain reaction in microbiology has been the development of
syndromic assays – assays that test for a range of pathogens commonly associated with a
particular syndrome such as a lower respiratory infection, a gastrointestinal infection, or
another specific infection.

Coagulation
Hemostasis (coagulation) is a complex process in which multiple enzymes and proteins

regulate blood flow and clot formation. Coagulation, fibrinolysis, and platelet aggregation
are a part of this process. Fibrinolysis is a normal body process that keeps naturally
occurring blood clots from growing and causing problems.
Anticoagulant drugs help prevent blood platelets from sticking or clumping together,
reducing the likelihood that arteries will be blocked by a clot, leading to heart attack. The
most widely used drug is Coumadin (warfarin) and is prescribed for patients with atrial
fibrillation, artificial valves, and phlebitis. Patients using warfarin require coagulation
monitoring or a regular blood clotting test known as the International Normalized Ratio
(INR, formerly known as the Prothrombin Time test).
There are newer oral anticoagulants on the market, such as rivaroxaban (Xarelto), apixaban
(Eliquis) and dabigatran (Pradaxa). They are at least as safe and effective as warfarin, and
they do not require regular coagulation monitoring with a PT/INR. However,
hematologists will use immunoassays to measure the amount of drug concentration in a
patient’s blood to assure that the amount of drug is in the therapeutic range. This is akin to
therapeutic drug monitoring by immunoassay of antibiotics (gentamicin), antiepileptics
(such as carbamazepine, phenytoin and valproic acid), and antipsychotics (such as
pimozide and clozapine).
Heparin is used in the treatment of a number of cardiac and coagulation conditions to

inhibit coagulation. Although heparin is highly effective, it is always associated with some
risk of hemorrhage and is only administered in the hospital. Currently, the Activated Partial
Thromboplastin Time (APTT) is the laboratory test most commonly used to monitor
heparin therapy.
Until recently most labs performed a small menu of routine tests including prothrombin
time testing (INR/PT), activated thromboplastin time (PTT), and coagulation time (ACT).
Larger labs would run a number of coagulation factor tests by chromogenic and
immunoturbidometric methods that includes tests for: D-dimer and chromogenic factor
assays. These techniques meld perfectly with automated immunoassay testing in the core
lab and so there has been a steady migration of D-Dimer testing into the core lab.

In the treatment of COVID-19, coagulation testing, including d-dimer, is considered to be a

growing indicator in the impact and clinical outcomes of patients with COVID-19.
Screening with coagulation panels, including d-dimer, prothrombin time, platelet counts,
and fibrinogen, is considered to be essential to identifying patients with severe COVID-19
risk and potential negative outcomes. Several international organizations are leading the
charge in identifying and publishing recommendations and guidances for coagulopathy
management in COVID-19 patients.
Table 3-7: U.S. Coagulation Diagnostics Market by Segment , PT/INR, Molecular-lab Thrombophilia SNPs,
D-Dimer, 2022-2027 (in millions $)
PT/INR $519 $622 3.7%
Molecular $72 $94 5.4%
D-Dimer $477 $550 2.9%
Total $1,068 $1,266 3.5%

Source; Kalorama Information
Figure 3-9: U.S. Coagulation Diagnostics Market, 2022-2027 ($ millions)

Histology
Histology and cytology are the study of tissue (and cells, respectively). Histological or
tissue analysis involves a two-step procedure: preanalytical sample preparation and
advanced staining. Sputum, cervical and synovial fluids, and bits of tissue that have been
biopsied or surgically removed are processed, placed on glass slides, and stained to
characterize targeted cellular constructions, tissue morphology and cell components.
Trained technologists perform a first pass screen of the stained slides. Pathologists further
investigate tumor section slides and others that are found to have suspicious or aberrant
cells. The tests are used primarily to detect cancer and infectious agents in tissue and
cervical fluid, but the reader is reminded that every organ or piece of tissue removed from a
patient during surgery is also processed and analyzed in this two-step procedure.
Anatomical pathology was highly labor intensive and prone to subjective interpretation
through manual review but has been aided through the introduction of automated slide
workflows, digital imaging, and advanced stains such as immunohistochemistry (IHC) or
antibody reagents and in situ hybridization (ISH) or nucleic acid probes. Workflow
automation, digital image analysis and advanced stains have injected significant value into
the U.S. histology diagnostics market at a time when demand for associated testing has
risen with demographic aging and diseases such as cancer, diabetes, autoimmune diseases,
and neurodegenerative conditions.
Table 3-8: U.S. Histology/Cytology IVD Market by Segment (Pap Tests, in situ Hybridization,
Immunohistochemistry, Traditional non-Pap Stains, HPV Molecular) 2022-2027 ($ millions)
Segment 2022 2027 CAGR %
Pap Tests $380 $407 1%
in situ Hybridization $311 $452 8%
Immunohistochemistry $735 $907 4%
Traditional non-Pap Stains $161 $185 3%
HPV Molecular $234 $302 5%
Total $1,822 $2,254 4%

The majority of the U.S. histology market relates to cancer screening, cancer diagnosis,
monitoring, and therapy. The largest cytology test market in the United States is the Pap
smear; leading Pap platforms such as the Hologic ThinPrep and BD SurePath use liquid
sample protocols that enable automated follow-up testing for HPV and CT/NG (HPV DNA
and RNA tests are included under the molecular microbiology / virology market segment).
Outside of LDTs, current molecular companion diagnostic tests in the United States for
oncology are run on tissue samples. Rising cancer incidence coincident with aging U.S.
demographics will drive the majority of growth in the U.S. histology diagnostics market,
coupled with the introduction and penetration of advanced histologic assays featuring
hybridization and digital imaging technologies.
Figure 3-10: U.S. Histology and Cytology Diagnostics Market, 2022-2027 ($ millions)

Hematology
On par with clinical chemistry as far as platform maturity, core lab hematology has seen a
complete transition in U.S. core labs from impedance to optical- or flow cytometry-based
detection methods for blood cell counts. Hematology uses various counts and measures
from whole blood samples to aid in the diagnosis of monitoring of leukemia, anemia and
autoimmune diseases. Complete blood cell (CBC) tests performed on hematology analyzers
include various test parameters relating to hemoglobin (Hg/HGB), red blood cells (RBC),
platelets (PLT), white blood cells (WBC), nucleated red blood cells (NRBCs), and
reticulocytes (immature RBCs; RETIC). Differentials provide cell counts and other
parameters relating to blood-borne cell populations such as WBC subtypes, reticulocytes,
or platelets. Ancillary hematology instrumentation includes slidemakers/slidestainers and
specialized digital cell imaging systems that perform automated visual differentials or
counts and analysis of blood cells.
The hematology diagnostics segment includes instrumentation and consumables used for
the following tests and lab procedures:
• Automated full or complete blood counts (CBC)
• Manual or automated blood cell differentials
• Slidemaking/staining for hematology testing samples
• Digital blood cell imaging
Kalorama Information estimates that over 500 million blood counts are performed in the
United States every year. Hematology reagents and consumables are very low-cost on a
per-test basis, but represent a significant market based on overall volume.
The CBC is one of the most requested lab tests, if not the highest requested lab test, in any
healthcare system. Underlying market growth for laboratory hematology is slight, bolstered
in recent years by enrollment in healthcare and increased utilization, but otherwise will
depend in the coming years on workstation automation, analyzer feature upgrades
(parameters and sensitivity), and the introduction of new instrumentation. COVID-19
increased some utilization of hematology panels and prompted earlier-than-scheduled
orders of analyzers to meet the needs of volume early in the pandemic, this installed base

will continue to impact volume and capabilities in testing for the forecast period. The U.S.
market for hematology diagnostics is expected to grow from $1,895 million in 2022 to
$2,242 million in 2027 (CAGR: 3.4%).
Table 3-9: U.S. Lab-based Hematology Market by Analyte Segment (CBC, Hemoglobin, and Other), 2022-
2027 (in millions $)
Segment (est) 2022 2027 CAGR
CBC 1,115 1,310 3.3%
Hemoglobin 535 615 2.8%
Other 245 317 5.3%
Total 1,895 2,242 3.4%
Figure 3-11: U.S. Hematology Diagnostics Market, 2022-2027 ($ millions)

Hematology cell counting has progressed from impedance-based technology (the basis of
the Coulter Principle) by borrowing from flow cytometry. Incorporation of laser excitation
and fluorescence detection into the hematology analyzer has grown the instruments’ cell
discrimination abilities to include blood cell components that previously required labor
intensive and inexact manual methods. While hematology has borrowed from flow
cytometry through the incorporation of laser light scatter technology into analyzers, flow
cytometry is included as a separate IVD segment defined by the prevalent use of antibody
markers and other specialized reagents.
The field of hematology diagnostics continues to advance through the addition of new
parameters to the analyzer such as platelet counting, reticulocyte counting, and CD4/CD8
analysis. The second front of expansion is the analysis of other body fluids on the same
platform. Differentiation between marketed platforms is also accomplished through
automation strategies including analyzer integration onto a core lab automation track, the
addition of an automated slidemaker/stainer, digital cell imaging technology and
bioinformatics software.
Individual hematology players have distanced themselves from competition with the
introduction of exclusive clinical parameters. In the past five years, major vendors have
added several advanced reticulocyte parameters, platelet parameters, white blood cell
differentials, flow cytometry capabilities, and body fluid applications to analyzer models.
The impact of these added analyzer parameters and features on competitor performance has
varied. Reticulocyte parameters are increasingly standard among even medium-volume
analyzers and have significant clinical value in the specific diagnosis of anemias and real-
time monitoring of erythropoiesis in hematology patients.
CellaVision is the dominant and near-exclusive market player in hematology digital cell
imaging; the company’s instrument placements have predominated in the United States.
Beckman Coulter is the U.S. market leader for laboratory hematology, followed by global
market leader Sysmex.
The recent expansion of special tests run on hematology analyzers and body fluid
applications has given this sector new life. Years of slow growth is one of the main reasons
from a market perspective that the new flow cytometry cell-based test capability on
hematology analyzers is important. In the U.S. sales continue to be moderate with growth
supported by an increasing aging population and the growing trend to use laboratory as a
tool in diagnosis and treatment. The U.S. market has been partially offset in growth due to

an extremely cost-conscious environment. Replacement demand for hematology analyzers

in the mature U.S. has been largely hit by laboratory consolidation and increase in the
number of group-purchasing organizations.

Blood Testing and Typing
Blood banks use three classes of IVD products:
• blood grouping and typing reagents and instruments
• immunoassays to screen for blood borne pathogens
• nucleic acid tests (NAT) to screen for blood borne pathogens
The U.S. market for blood testing and typing diagnostics is valued at $1,056 million for
2022 ($507 typing/grouping; $549 screening). The market is expected to show 1.6% CAGR
to reach $1,141 million by 2027.
In the United States, aaccording to AABB (formerly American Association of Blood

Banks) there are 2,400 accredited blood centers in the U.S. The number of blood units
collected in the United States was 13.6 million in 2019. Almost all blood collected in the
United States comes from unpaid voluntary donors; half is collected by community blood
centers, 44% by the American Red Cross, and the last 6% is collected by hospital blood
banks. Volume in U.S. blood donations varied significantly from quarter to quarter during
2020, 2021 and the first half of 2022.
Blood grouping and typing reagents and instruments are used by blood transfusion services,
hospital and private blood banks and hospital laboratories that prepare blood units for
transfusion to patients. Rare ABO alleles may result in weak antigen activity using
traditional grouping reagents and processes. Therefore, blood bank professionals have
begun using molecular methods to clarify these rare cases, which are becoming more
frequent as more cancer patients receive blood transfusions. Increasing sophistication in
blood typing will provide marginal growth to the U.S. blood testing market, but not enough
to offset declining transfusion volumes.
As an extension of infectious disease testing applications, molecular technology is used

widely in the screening of donated blood for pathogenic agents. Nucleic-acid testing (NAT)
is playing an important role as the most advanced technology for directly detecting
infections in blood. Today, NAT has been adopted in many countries around the world,
including in the U.S. Nucleic acid tests account for approximately 80% of the U.S. blood
screening market and are standard for testing of donated blood. The United States requires
100% of all blood donations to be screened for HIV-1, HCV, HBV and WNV using nucleic

acid testing. All blood banks in Latin America and some in the United States also screen
donated units for Chagas disease using immunoassays. Traditionally, Grifols’ strength has
been in the U.S. market and Roche in Asian and European markets.
Table 3-10: U.S. Blood Testing and Typing by Segment (ABO Grouping/Typing and Screening), 2022-2027
(in millions $)
ABO Grouping/Typing $507 $539 1.3%
Screening $549 $601 1.8%
Total $1,056 $1,141 1.6%
Figure 3-12: U.S. Blood Grouping and Typing Diagnostics Market, 2022-2027 ($ millions)

Figure 3-13: U.S. Blood Screening Diagnostics Market (Immunoassay Blood Screening and NAT Blood
Screening), 2022-2027 ($ millions)

Total U.S. IVD Market
The U.S. market dominates the IVD industry. In 2022, the U.S. occupies 42% and about
$54 billion of the global market for IVD products. This major IVD market is in a state of
flux, trying to manage a myriad of issues, all of which collide with a huge system that costs
more than any other in the world.
COVID-19 has had a profound effect on the IVD diagnostic industry – some segments
exploded, and others languished. At this point in time, it is hard to predict how the
Coronavirus will impact the forecast years to 2027, but Kalorama has attempted to provide
insight into the industry by conversing with market participants and government entities. It
is realistic to assume the market for COVID-19 will remain a component of the IVD market
as the continued prevalence of the virus and the evolving variants are expected to remain. It
should be noted that the market can be uncertain and ongoing research will help determine
the long-term path of the segment in the coming months to years.
The POC diagnostics market represents the largest IVD segment in the United States;
consisting of both the POC diabetes segment ($8,617 million, 2022) and POC non-diabetes
segment ($11,996 million, 2022), which includes infectious disease (including COVID-19).
The large market segment reflects the diversity of diagnostic technologies that migrated to
near-patient settings and the importance of POC testing for preventative care; not to
mention the strong demand for COVID-19 POC tests over the past two years.
The third- and fourth-largest U.S. IVD segments, immunoassay infectious disease and
molecular microbiology, were certainly buoyed by the need for COVID-19 testing. The
majority of immunoassay testing volume in the United States is run on core lab
immunoassay analyzers or combined immunochemistry instruments.
More dynamic IVD segments in the U.S. market include microbiology, molecular
diagnostics, and histology. The leading growth rates for molecular diagnostics and
histology out of all segments in the U.S. IVD market are products of their roles in rapid and
sensitive pathogen detection, accurate viral load monitoring, and in oncology, from risk
assessment through tumor monitoring. Cancer represents one of the most burdensome
diseases on the U.S. healthcare system. Demographic aging in the United States will
continue to increase nationwide cancer incidence.

Molecular diagnostics are uniquely responsive to infectious disease threats in the United
States. Market growth for molecular infectious disease tests in the United States exploded
in 2020 and has carried through to 2022 due to the pandemic.
Rising analytical speeds in sequencing allows for the rapid development of new probe and
primer reagents for use in molecular test kits. Future clinical molecular assays for infectious
disease may directly incorporate sequencing due to the technology’s ability to openly read
pathogenic genomes for new resistance genes and other traits significant in therapy
decisions.
Market performance between U.S. IVD segments has been inconsistent due to the
pandemic. Core lab market segments in the United States are projected to grow by a little
more than 1.1% through 2027.
In wider context, the United States remains the core geographical IVD market in the world
at over $54 billion in sales or approximately 42% of the global market. Market growth in
some segments in the United States has been accelerated due to the pandemic and the need
for testing for COVID-19. The U.S. IVD market is projected by Kalorama Information to
reach over $59 billion in 2027.

Table 3-11: U.S. IVD Market including COVID-19, by Segment (Clinical Chemistry, Microbiology - ID/AST,
Molecular, Molecular Infectious Disease Molecular – non, Infectious Disease, POC Diabetes, POC – Other,
Immunoassay, Immunoassay Infectious Disease, Immunoassay non-Infectious, Coagulation, Histology,
Hematology, Blood Typing, and Others), 2022-2027 (in millions $)
Clinical Chemistry $3,481 $3,671 1.1%
Microbiology - ID/AST 1,775 $2,089 3.3%
Molecular
$9,907 $10,074 0.3%
$8,081 $7,178 -2.3%
(with NAT & mass spec)
$1,826 $2,897 9.7%
Molecular - non-Infectious Disease
POC Diabetes (all) $8,617 $11,502 5.9%
POC - Other $11,996 $11,210 -1.3%
Immunoassay $12,891 $14,225 2.0%

Immunoassay Infectious Disease $8,315 $8,813 1.2%
Immunoassay non-Infectious $4,576 $5,412 3.4%
Coagulation $1,068 $1,266 3.5%
Histology $1,822 $2,254 6.2%
Hematology $1,895 $2,242 3.4%
Blood Typing $507 $539 1.3%
Others $74 $81 1.8%
Total $54,033 $59,154 1.8%

Figure 3-14: U.S. IVD Market Segments (Clinical Chemistry, Microbiology - ID/AST, Molecular, Molecular
Blood Typing, and Others), 2022 (%)

Chapter 4: Top Tier U.S. IVD Market Players
The top players in the U.S. IVD market are individually profiled in alphabetical order. The
profiles cover notable corporate events and developments from 2019-2022. Revenue
leaders in the U.S. IVD market are heavily represented in this chapter and profiles were
chosen based on the extent of IVD companies’ sales in the United States and/or innovation
within the past couple of years.
Table 4-1: 2021 U.S. IVD Competitor Revenues ($ millions)
Company U.S. Revenues ($millions) est
Abbott 9,187
Roche 5,190
Danaher (all) 3,741
Siemens Healthineers 3,182
Thermal Fisher 2,897
Beckton Dickinson 2,564
Hologic 2,390
Illumina 2,350
Dexcom 1,860
bioMerieux 1,675
Exact Sciences 1,661
Ortho Clinical 1,187

Abbott Diagnostics
Abbott Park, IL 60064

www.abbott.com
Recent Revenue History
Table 4-2: Abbott Diagnostic Revenues 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Total Dx $7,018 $9,428 $10,237 $14,072 $19,972
Revenues reached $19,972 million in 2021. Sales increased 41.9% driven by demand for
Abbott’s rapid diagnostic tests for COVID-19 and an uptick in diagnostic testing in the core
laboratory. The United States garnered 46% of sales.
Figure 4-1: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated

The following is Kalorama’s estimated breakdown of Abbott's revenue in selected test

segments ($ million, estimated):
Table 4-3: Global Abbott Diagnostic Revenues, 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Histology (Vysis) $230 $240 $251 $227 $276
Chem/Immuno $3,595 $3,870 $4,105 $3,947 $4,852
Hematology $270 $285 $300 $248 $311
Molecular $463 $484 $442 $1,438 $1,427
Point of Care $550 $553 $561 $516 $536
Diabetes $1,370 $1,933 $2524 $3267 $4,328
Rapid & Alere $540 $2,072 $2,054 $4,892 $8,553
Abbott Diagnostics maintains a core focus area of infectious disease testing, with a
significant portion of sales generated in the European Union, emerging markets, and the
U.S. The company is preparing for the future with the development of next generation
systems, informatics to help labs manage and retrieve test data, new infectious disease
diagnostics, and gene-based oncology tests for targeted therapeutics. Abbott's diabetes care
attained worldwide sales of $4,328 million in 2021, an increase of 33%,
The core lab revenues increased 15% and the POC market increased 3%. Rapid diagnostics
increased 95% and Molecular decreased, 1%.
Core Lab
Abbott’s core lab products include: ABBOTT PRISMnEXT, an automated immunoassay

analyzer designed to perform chemiluminescent immunoassay (ChLIA) technology; the
ARCHITECT family of instruments run chemistries and immunoassays for cancer,
infectious disease, cardiovascular and thyroid disease, fertility and pregnancy. Abbott
reported that more than 10,000 Architect systems are used worldwide.

Also included in the core lab tools base are immunoanalyzers, hematology systems and
now coagulation instrumentation. Abbott reported the company is working on the
development of next-generation blood screening, hematology, and immunochemistry
instrument systems, as well as assays in various areas including infectious disease, cardiac
care, metabolics, oncology, and automation solutions to increase efficiency in laboratories.
In March 2019, Abbott was awarded the CE Mark for its Alinity M molecular diagnostics
system and assays, which are now available in countries that recognize the designation.
The MDx platform offers a number of initial assays, including virology testing for human
immunodeficiency virus type 1, hepatitis B virus, and hepatitis C virus; sexual health-
related testing for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis,
and Mycoplasma genitalium, or a CT/NG/TV/MG panel; and high-risk human
papillomavirus testing. The Alinity M is not available in the U.S. for diagnostic use.
Abbott is marketing the Alinity M as having the ability to revolutionize molecular testing
and to one workstation to replace multiple molecular instruments. Its ReadiFlex
technology enables random access testing with STAT prioritization and continuous sample
loading for a broad test menu.
Hematology
Abbott’s hematology offering is the Alinity h-series next generation system (not
commercially available in all countries, including the U.S.) According to Abbott “with
multiple configurations including combinations of the Alinity hq analyzer and the Alinity
hs slide maker stainer, the Alinity h-series hematology solution provides options for
additional capacity, backup systems and integrated slide making and staining.”
The Alinity h-series of systems integrates hematology workflow, from high-throughput

Complete Blood Count (CBC) analysis to automated slide making and staining. The
Alinity hq analyzer delivers a Complete Blood Count (CBC) with a 6-part White Blood
Cell (WBC) differential and several parameters using Advanced MAPSS (Multi Angle
Polarized Scatter Separation) technology. The design incorporates additional angular
intervals of light scatter to improve differentiation of the WBC, Red Blood Cells (RBC)
and platelets as they pass through the detection area of the optical flow cell.
According to company information, together with the use of multi-paradigm numerical

computer tools, a machine-learning cell classifier, a Gaussian Mixture Model (GMM) and a

Graph Adaptive Clustering (GAC), the Alinity hq technology represents an advancement in

cellular analysis for hematology.
Blood Banking
In January 2019, Abbott announced that it has been selected by the Japanese Red Cross
Society (JRC) to partner in screening the country’s blood donations. The eight-year
contract is for the exclusive supply of serological instrumentation, tests, and consumables
used for blood and plasma screening. The JRC screens approximately 5 million blood
donations each year.
Abbott said it will provide the JRC with its technology, medical and scientific research, and
expertise in efficiency through lab automation. The JRC will screen each donation across
eight distinct assays, including hepatitis and retrovirus analysis.
In July 2019, Abbott received approval for the Alinity s System. The Alinity s System is
designed to screen blood and plasma more efficiently within a smaller space versus
commercially available competitive systems. In a testing specialty that can require
extensive hands-on time, the additional automation and flexibility of Alinity s is designed
to help blood and plasma centers improve productivity and maintain the highest levels of
accuracy.
Infectious Diseases - Molecular
Abbott is a leader in immunoassays and is translating this expertise to molecular assays.

Abbott is making a huge effort to improve its molecular test menu. Abbott Molecular
(www.abbottmolecular.com) analyzes DNA, RNA, and proteins at the molecular level. In
general, Abbott Molecular focuses on tests for the evaluation and management of cancer,
prenatal disorders, infectious diseases and other genetic diseases.
Abbott Diagnostics’ legacy molecular assays include: Real-time PCR for CT/NG, hepatitis
and HIV, sequencing, and bead array. Sequencing products include ViroSeq HIV-1
Genotyping System and HBV Sequencing Assay
Abbott has expanded its test menu, with new assays introduced for HCV genotyping,
vancomycin-resistant enterococci, and influenza A/B and respiratory syncytial virus, all for
its automated m2000 molecular testing system. The next 12 months are expected to bring a

test for Clostridium difficile, as well as an HSV-1 and HSV-2 assay. These assays will
round out the system’s menu, which includes HIV-1, hepatitis B and C viral load, and a
chlamydia/gonorrhea combination test.
In March 2021, the FDA granted EUA for Abbott’s Alinity mResp-4-Plex assay; designed
to allow healthcare workers to test for four viruses in one test.
In May 2022, Abbott received FDA clearance for its Alinity m STI system that detects four
infectious simultaneously. The Alinity m STI tests for Chlamydia trachomatis, Neisseria
gonorrhea, trichomonas vaginalis and mycoplasma genitalium. This is the first multiplex
test designed for STIs.
Diabetes
Abbott’s advanced continuous glucose management offering is headed by the FreeStyle

Libre system that reads glucose levels through a sensor that can be worn on the back of the
upper arm for up to 14 days, eliminating the need for routine finger pricks. In addition, no
finger prick calibration is needed, which according to Abbott is a key differentiator from
current continuous glucose monitoring systems.
In February 2019, Abbott and pharmaceutical company, Novo Nordisk, announced a non-
exclusive partnership that integrated insulin dose data from Novo Nordisk pre-filled and
durable connected pens directly into the digital health tools compatible with the FreeStyle
Libre system that includes the FreeStyle LibreLink mobile app and LibreView cloud-based
system). An Abbott press release said: “integrating these two products enables healthcare
professionals, caregivers and people with diabetes to view glucose and insulin data
together to help them make more informed treatment decisions and to have a more
meaningful and productive conversation about health outcomes.” Abbott and Novo
Nordisk are working hard to bring these integrated solutions to patients as soon as possible.
Abbott's FreeStyle LibreLink app is available free of charge for both iPhone and Android,
initially in 12 European countries including Austria, Belgium, Finland, France, Germany,
Ireland, Italy, Spain, Sweden, Netherlands, Switzerland and the United Kingdom.
Abbott’s mobile application brings FreeStyle Libre monitoring functionality to users’

smartphones. Abbott is aiming to provide a mobile app solution for FreeStyle Libre users
outside of Europe, based on in-country regulatory approvals.

In addition to glucose monitoring devices, Abbott markets a number of other products to

aid in the diagnosis, monitoring and management of diabetes. Abbott's ARCHITECT and
i-STAT Systems feature various tests to either diagnose diabetes or monitor blood glucose
levels. The company also offers Glucerna, specialized nutrition products that are designed
to help people with diabetes manage blood glucose levels as part of an overall management
plan.
In February 2020, Abbott entered into a partnership with Insulet to integrate glucose
sensing and automated insulin delivery.
In June 2020, Abbott entered into a partnership with Tandem Diabetes Care to integrate
Abbott’s FreeStyle Libre CGM with Tandem’s insulin delivery products.
In September 2020, Abbott announced the introduction of Libre Sense Glucose Sport
Biosensor, which is designed for athletes to continuously measure glucose while the athlete
is performing. Additionally, in September 2020, Abbott received CE marking for its next-
generation FreeStyle Libre 3 System. The FreeStyle Libre 3 technology provides
continuous, real-time glucose readings automatically delivered to smartphones every
minute, offering unsurpassed 14-day accuracy in the smallest and thinnest sensor design.
In August 2021, Abbott’s Freestyle Libre 2 IOS app was cleared. The app is the only
sensor-based glucose monitoring app that allows users to check glucose with a compatible
phone. It is free to download on the App Store.
In September 2021, Abbott reported that with its new Free Style Libre’s smart phone app,
patients experienced an average of 1.2 hours in the target glucose range than those patients
with a reader. This data reinforces the benefits of mobile apps to help control diabetes. The
technology helps diabetic patients make smart lifestyle choices that are personalized.
In March 2022, Abbott received expansion of reimbursement coverage for its FreeStyle
Libre system in Japan. The reimbursement expansion went into effect April 2022.
In May 2022, Abbott received FDA clearance for its FreeStyle Libre 3 system. The
FreeStyle Libre 3 is the smallest, thinnest and accurate 14-day glucose sensor. It is
available at the same price as previous versions.

In June 2022, Abbott announced that it is developing a new biowearable that will
continuously monitor glucose and keytone levels in one sensor. The new sensor will be the
same size as the FreeStyle Libre 3 sensor.
"Abbott revolutionized diabetes care with FreeStyle Libre® technology, which is the
number one continuous glucose monitor used by 4 million people around the world," said
Jared Watkin, senior vice president of Abbott's diabetes care business. "We're designing
our glucose-ketone monitoring system with superior sensing technology that will pair with
industry-leading insulin pumps to create a best-in-class solution. We're optimistic that this
will be the next big advancement in diabetes tech and a breakthrough for people with
diabetes, especially those who are at risk of developing diabetic ketoacidosis.
HIV Point of Care
Abbott introduced the world’s first HIV test in 1985. The company’s HIV portfolio
includes tests for screening, monitoring, management and connectivity for use in the lab
and at the point of care. The company continues to invest in HIV testing.
In May 2019, Abbott received World Health Organization prequalification approval for its
m-Pima HIV-1/2 VL viral load diagnostic test, a portable molecular point-of-care platform.
Abbott stated the platform can be deployed in the most remote locations and at the point of
care to measure viral load in under 70 minutes, allowing people to receive results during the
same visit and enabling immediate treatment decisions, which can reduce the number of
people lost to follow-up.
i-STAT Business
Abbott point-of-care products provide healthcare professionals immediate access to

accurate, critical diagnostic test results at the point of patient care. The i-STAT System
provides time-sensitive test results at the patient's side in just minutes. To perform a test,
the user places two or three drops of whole blood on the test cartridge, which is then
inserted into the analyzer. A new test cartridge is used for each patient. Utilizing test-
specific cartridges that are fully self-contained, the i-STAT System delivers lab-accurate
testing for blood gases, electrolytes, chemistries, coagulation, hematology, lactate, glucose
and cardiac markers. The system is used at the patient’s bedside, in emergency
departments, operating rooms, and critical care units.

In January 2021, Abbott received clearance for its rapid handheld blood test for
concussions. The test helps to evaluate TBI, producing a result in under 15 minutes. It runs
on Abbott’s i-STAT Alinity handheld device.
In August 2022, Abbott is pursuing FDA clearance under Breakthrough Designation for its
TBI test on its Alinity and ARCHITECT core laboratory instruments.
COVID-19
In March 2020, Abbott received EUA authorization from FDA to launch the Abbott
RealTime SARS-CoV-2 test to be run on the m2000 RealTime system. The platform uses
polymerase chain reaction (PCR) technology, which amplifies a single piece (or few copies
of a piece) of DNA to quickly and accurately diagnose a patient. The m2000 is currently
used in labs around the world.
Additionally, in March 2020, the company launched Abbott ID NOW COVID-19 rapid
test. The test runs on Abbott’s molecular POC ID NOW platform.
In April 2020, Abbott launched a new antibody test, SARS-CoV-2 IgG tests, which
identifies the IGG antibody. The test runs on ARCHITECT i1000 SR and i2000
instruments.
In May 2020, Abbott received FDA EUA authorization for COVID-19 antibody test on
Alinity i. The Alinity i system is Abbott's next-generation immunoassay instrument, which
was designed to offer greater efficiencies to lab clinicians running tests.
In August 2020, Abbott launched its AdviseDx SARS-CoV-2 IgM laboratory-based

serology test for use on its ARCHITECT and Alinity platforms. The product was CE
marked and Abbott was granted FDA EUA authorization in the U.S.
Additionally, in August 2020 Abbott launched its BinaxNOW COVID-19 Ag Card Test,
which is a portable, lateral flow rapid test.
In September 2020, Abbott launched its Panbio rapid antigen test designed to detect
COVID-19 after receiving CE mark. In October 2020, the company received approval by
the WHO for emergency use of Panbio. In January 2021, the test received CE Mark.

In December 2020, Abbott received FDA EUA authorization for the first virtually guided,
at-home rapid COVID-19 test using Emed’s digital platform.
In April 2021, Abbott received FDA EUA for the BINAXNOW Rapid Antigen Self-Test
for use by people with or without symptoms.
In June 2021, Abbott received CE mark for its Panbio Rapid antigen self-test. It is approved
for sale directly to consumers with or without symptoms.
Additionally, in June, Abbott and Walgreens launched a pilot program providing rapid
BinaxNOW COVID-19 Antigen Test to increase access to rapid OTC test for Pennsylvania
EBT cardholders in Philadelphia.
In June 2022, the BinaxNOW rapid test received FDA EUA for use at home without a
prescription through a virtually guided online service. The test provides results in minutes
and detects the virus in the early part of the disease. The guided virtual online service will
be provided by eMed at a cost of $25.
In June 2022, Abbott announced the availability of its BinaxNOW COVID-19 Self-Test is
available at CVS Pharmacy, Walgreens and Walmart. The rapid antigen self-test detects
both asymptomatic and symptomatic COVID-19 and is identical to the professional test.

Beckman Coulter, Inc. / Danaher
Brea, CA
www.beckmancoulter.com
Table 4-4: Beckman Coulter Diagnostic Revenues 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Clinical Diagnostics $3,620 $3,851 $4,056 $4,176 $4,928
Beckman Coulter was acquired by Danaher Corporation in February 2011. As a result,

2011 is the last year for which company data can be reported with certainty. Beckman
Coulter reported revenue of $3,250 in 2011. Therefore, Beckman Coulter’s IVD revenue
estimates provided here are based on general information provided by parent company
Danaher.

The following is an estimate of Beckman Coulter's revenue in selected test segments,
Table 4-5: Global Beckman Coulter Revenues in Selected Test Segments 2019-2021 (millions $) estimated
Item/Year 2019 2020 2021
Routine Chemistry $1,415 $1,289 $1,373
Immunoassays $1,021 $950 $1,049
Hematology $770 $727 $764
Microbiology $340 $770 $1,293
Coagulation $151 $127 $128
Flow Cytometry $325 $313 $320
Beckman Coulter, Inc., a subsidiary of Danaher Corporation (DHR), develops,

manufactures and markets IVD tests for more than 80 years. The company reports that
more than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences
laboratories on six continents.
With an 80-year history, Beckman Coulter’s scalable instruments, comprehensive

diagnostic test portfolio and business management services are used by hospitals,
laboratories and other critical care settings around the world.
Hematology
Beckman Coulter had the #1 position worldwide for some time; however, aggressive
marketing by Sysmex has put the companies competing neck in neck for the top spot in
hematology, with Sysmex winning the race in the past few years.
Beckman Coulter maintains its position with a series of innovations in a crowded and
mature market. Beckman Coulter offers a complete product line, including the COULTER
LH 785 work cell, which adds slide making and staining to a high throughput system.

Beckman Coulter Diagnostics released the CE Marked DxH 500 hematology system, an
open-vial instrument offering a throughput of up to 60 samples per hour. Beckman Coulter
announced that the DxH 500 hematology system is the first analyzer in a new range of
workflow-efficient hematology analyzers able to deliver results from a finger stick blood
sample.
The DxH 500 analyzer has been specifically designed for low-volume hematology
workloads and to promote rapid specimen turnaround and reduce patient wait times in
small- and medium-sized clinics. Smaller than a standard microwave, the instrument is
able to provide a complete blood count (CBC) plus a 5-part differential from as little as
12μL of whole blood or from 20μL of whole blood for pre-dilute analysis. This (according
to company information) makes the DxH 500 ideal for pediatric and geriatric patients, for
whom sample taking can be difficult. The DxH 500 is part of Beckman Coulter’s line of
DxH hematology solutions that includes the DxH Workcell, DxH 800 Cellular Analysis
System and DxH Slidemaker Stainer.
Beckman Coulter announced the release of the CE Marked and FDA cleared DxH 900
hematology analyzer, giving mid- to high-volume clinical laboratories the ability to
perform complete blood count and white blood cell differential tests with minimal repeats.
The DxH 900 is available for sale in Europe, the United States, Australia and New Zealand.
Foundational to the system are its core technologies, including the enhanced Coulter
Principle, VCS 360 and DataFusion. These features (according to Beckman Coulter) offer
high-resolution analysis of cells in their near-native states, providing a precise cellular
assessment for excellent red blood cell, platelet and white blood cell test results on the first
pass.
Many of the parameters available with the DxH 900 analyzer are designed to directly
impact patient care by addressing critical conditions, such as thrombocytopenia, anemia
and leukopenia.
This hematology-based solution is designed to alert emergency department clinicians to the

possibility of sepsis or risk of developing sepsis. According to Beckman Coulter, this is the
first early sepsis warning solution to be offered as part of a routine complete blood count
(CBC) with a differential test, i.e., part of the routine blood test.
Beckman Coulter launched its next-generation software to support the DxH 500 family of
hematology analyzers. The version 2 software upgrade gives small-volume clinical

laboratories access to a comprehensive suite of tools including a proprietary dynamic-

gating methodology for improved flagging and a sophisticated quality control (QC) menu.
With the new software, laboratories can ensure more accurate differentials through
Beckman Coulter’s proprietary dynamic-gating methodology. According to Beckman
Coulter, this technology is not available in any other small-volume, 5-part differential
instrument and it improves results flagging by adjusting the thresholds between cell cluster
arrangements. This, multi-layered system of adjustable gates, enables the analyzer to better
identify cell populations—particularly more challenging cell populations.
Beckman Coulter announced that it had filed a submission for 510(k) clearance with the
U.S. FDA for its Early Sepsis Indicator and in April 2019, Beckman Coulter received FDA
clearance for the Early Sepsis Indicator.
In March 2019, Beckman Coulter received FDA clearance to market the DxH 520
hematology analyzer. The instrument was CE Marked in April 2018. With just 17
microliters of blood or a finger stick sample, the DxH 520 enables low-volume laboratories
to deliver 5-part differential test results in 60 seconds or less. This feature delivers test
ideal for neonate, pediatric, and critical-care patients who are only able to provide a small
sample. The DxH 520 Closed Tube instrument offers a 5-part differential for small-volume
Labs.
Beckman Coulter’s DxH 520 builds on the organization’s history in hematology innovation
and complements its broad spectrum of hematology analyzers, including the DxH 600 for
mid-volume, DxH 900 for large-volume and DxH connected workcell solutions for ultra-
high-volume facilities.
In May 2019, the U.S. FDA alerted hospitals, laboratories and providers of a Class 1 recall
of Beckman Coulter DxH 800, DxH 600 and DxH 900 hematology analyzers. This is an
update to an urgent medical device correction letter first issued by Beckman Coulter in
2018, after the company had received complaints of inaccurate blood platelet counts.
In May 2020, BC launched the DxH 690T mid-volume hematology analyzer on the U.S.
market that includes the early sepsis indicator. The DxH 690T applies Beckman Coulter’s
core hematology technologies—the enhanced Coulter Principle, VCS 360 and
DataFusion—to streamline throughput, minimize reflex testing and reduce manual
interventions.

Beckman Coulter launched the DxU Iris Workcell in October 2021. The product is a fully
automated system that streamlines urinalysis workflow. The DxU Iris Workcell pairs the
DxU 850m Iris with the ARKRAY AUTION MaX 4030 urine chemistry analyzer for a
fully automated process.
Hematology IT
Beckman Coulter Diagnostics announced the global launch of next-generation software to

support new and existing DxH 500 hematology analyzers. The version 2 software upgrade
gives small-volume clinical laboratories access to a comprehensive suite of tools—
including a proprietary dynamic-gating methodology for improved flagging and a
sophisticated quality control (QC) menu. Software version 2 enhancements improve
flagging and streamline the quality control processes
Beckman Coulter reported that with the new software, laboratories can provide more
accurate differentials through Beckman Coulter’s proprietary dynamic-gating methodology.
The technology that according to Beckman Coulter, is not available in any other small-
volume, 5-part differential instrument. It improves results flagging by adjusting the
thresholds between cell cluster arrangements. This unique, multi-layered system of
adjustable gates, enables the analyzer to better identify particularly challenging cell
populations, giving laboratories confidence in the accuracy of results and reducing slide
reviews that can interrupt workflow.
Beckman Coulter reported that the upgrade further promotes operational effectiveness
through a flexible QC menu that is designed to help laboratories more easily meet
accreditation requirements. With the new software, laboratories can increase runs per file
from 100 to 150, creating greater efficiency in the QC process and providing assurance of
accurate
The new software also gives laboratories outside the U.S. access to research-use-only
(RUO) parameters. Other software improvements include a more streamlined setup menu,
enhanced user-access features, and added backup and restore functions.
Beyond its upgraded clinical excellence, the compact DxH 500 helps laboratories manage
resources. Its easy-to-use interface enables technologists to access any screen in three clicks
or less, saving valuable time. The system requires only three reagents that can be replaced

in five minutes or less. This is in contrast to competitive systems that use five or more
reagents, many of which are organic solvents, requiring additional costly disposal fees.
Clinical Chemistry
In clinical chemistry Beckman Coulter offers a menu of more than 150 chemistry and
protein tests. Beckman Coulter has responded to the chemistry/immunoassay work cell
trend by offering the UniCel solutions. Beckman Coulter offers a variety of workcells from
the mid-volume UniCel DxC 600i to the new high-volume DxC 880i, with three more
systems in development. The UniCel DxC 600 and DxC 800 chemistry systems can be
upgraded to work cells. All of Beckman Coulter’s core lab systems offer the traditional
chemistries and immunoassays.
Beckman Coulter received FDA clearance to market the DxC 700 AU chemistry analyzer.
The new system combines the design of the DxC analyzer and the throughput and
workhorse capabilities of the Olympus AU analyzer – into one standardized platform
designed for mid- to high-volume clinical laboratories.
The company stated the DxC 700 AU chemistry analyzer’s new operating software reduces
the number of test-processing steps by 30%. The DxC 700 AU analyzer is part of Beckman
Coulter’s Total Laboratory Solution, featuring a broader comprehensive portfolio that
provides the flexibility to tailor systems based on a laboratory’s volume and space needs.
The DxC 700 AU system is available in the U.S
Beckman Coulter added drugs of abuse tests: the Syva EMIT II Plus 6-AM for 6-
Acetylmorphine (6-AM) and the Syva EMIT II Plus BUP for Buprenorphine (BUP) assays
to its chemistry test menu. The tests are run on the Beckman Coulter’s scalable AU
chemistry analyzers (AU480/AU680/AU5800).
The company continues to expand the chemistry test menu. In March 2019, Beckman
Coulter was awarded the CE Mark and FDA market clearance for the fully automated
hemoglobin A1c (HbA1c) Advanced assay. The new assay enables mid- to high-volume
laboratories to provide physicians with a tool to monitor long-term glucose control and
identifying patients who may be at risk of developing diabetes. Beckman Coulter also
announced that the availability of the test on the DxC 700 AU.

Immunoassays
Beckman Coulter is a leader in protein analysis. The Beckman Coulter immunoassay menu
consists of more than 60 tests for cancer detection, cardiac disease, thyroid function,
reproductive endocrinology, women’s health, anemia, autoimmune conditions, diabetes,
therapeutic drug monitoring, general chemistry, hepatic function, infectious diseases,
inflammatory proteins, lipids, nutritional assessment, renal function, thyroid function, and
toxicology.
Beckman Coulter's Access family of immunoassay analyzers includes the Access 2

Immunoassay System, Synchron systems, the UniCel DxI 600 Access Immunoassay
System and the UniCel DxI 800 Access Immunoassay System, which perform up to 100,
200 and 400 tests per hour, respectively. Beckman Coulter continues to add novel and
proprietary tests from different sources.
Beckman Coulter Diagnostics and Diazyme Laboratories received FDA clearance to market
a new procalcitonin (PCT) assay for sepsis detection. The company reported it is the first
homogenous PCT assay for use on current Beckman Coulter AU models 480, 680 and 5800
chemistry analyzers.
Beckman Coulter announced the worldwide availability of the Access 2 immunoassay

system with new features that improve ease-of-use, workflow efficiencies, and system
reliability. The Access 2 provides remote PROService connectivity, on-the-fly reagent and
consumable loading, and delivers up to 100 tests per hour.
Beckman Coulter Diagnostics offers an extensive diagnostic testing menu for use on the
Access 2 immunoassay system, with tests that include, adrenal disorders, anemia, bone
metabolism, cardiac-related conditions, diabetes, infectious diseases, reproductive health,
endocrinology, thyroid and tumor markers.
Beckman Coulter was awarded the CE Mark clearance for a new high-sensitivity troponin
(hsTnI) assay that aids in diagnosing myocardial infarction for patients presenting with
chest pain or other ischemic symptoms. The Access hsTnI assay is available for use on the
Access 2, DxI and the entire Beckman Coulter family of Access immunoassay systems.
Beckman Coulter received FDA clearance to market its automated Access AMH
immunoassay (Anti-Müllerian Hormone). The test aids healthcare providers in the
assessment of a woman's ovarian reserve and helps guide the clinical management of

women struggling with infertility or planning to become pregnant later in life. The Access
AMH assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative
determination of AMH levels.
The test is a continuation of Beckman Coulter’s AMH test development. The company
developed the first ELISA AMH assay and the first automated AMH tests. Further,
Beckman Coulter reports that its AMH antibody is used in all automated AMH assays
available in the U.S. today and that Beckman Coulter owns the exclusive rights to AMH
antibodies for Müllerian Inhibiting Substance Levels and Ovarian Response.
Beckman Coulter announced the addition of 6-Acetylmorphine (6-AM) and Buprenorphine

(BUP) assays to its menu of drugs-of-abuse tests on the company’s AU chemistry analyzer
solutions (AU480/AU680/AU5800). The Syva EMIT II Plus 6-AM assay provides a
convenient and quick way to selectively screen for heroin usage and the Syva EMIT II Plus
BUP assay is intended for use in laboratories for the qualitative and/or semi-quantitative
analysis of buprenorphine in human urine.
Beckman Coulter formed a partnership with quality control product company Technopath
(Ireland) whereby Beckman Coulter is tasked with distributing the full range of
Technopath’s CE Marked Multichem QC products, including QC materials and its IAMQC
data management solutions, in over 100 countries. IAMQC software platform automates
the handling and management of QC data. Beckman Coulter anticipates distribution of an
initial set of Technopath QC products for chemistry and immunoassay under this agreement
in Europe immediately, with other regions to follow as registrations are completed.
Beckman Coulter announced the worldwide commercialization of its Access Sensitive

Estradiol. The test is commonly ordered for detecting estradiol levels in women, children
and men in response to reproductive health questions. The launch of Access Sensitive
Estradiol follows the recent FDA clearance of Beckman Coulter's automated Anti-
Müllerian Hormone (AMH) assay in the United States. Together, these assays expand the
company's reproductive health portfolio, making it a comprehensive menu of reproductive
endocrinology and prenatal screening assays. The reproductive portfolio is available for
use in common reagent packs and with standardized results on the entire Beckman Coulter
family of immunoassay systems -including the Access 2, DxI 600 and DxI 800.
In Beckman Coulter received FDA clearance to market its Access hsTnI (high sensitivity
troponin) for use on the Access 2, DxI and the entire Access family of immunoassay

systems. According to Beckman Coulter: the assay can measure very low cardiac troponin
concentrations and may help physicians with the early diagnosis of myocardial infarction
and future risk stratification in and outside the acute coronary syndrome setting.
Laboratories have increased testing flexibility with this assay as it is the only high-
sensitivity assay to use either plasma or serum samples.
In March 2019, Beckman Coulter was awarded the CE Mark for the Access PCT assay for
use on the Access Family of Immunoassay Systems including the Access 2, UniCel DxI
600 and UniCel DxI 800. Access PCT assay (procalcitonin) helps physicians assess the
risk of patients progressing to severe sepsis or septic shock with test results available in
under 20 minutes. Access PCT enables healthcare providers to integrate procalcitonin
testing analysis into their routine sepsis workups on core laboratory analyzers, as a primary
or reflex test programmed though Beckman Coulter’s REMISOL Advance middleware.
In January 2020, the company received FDA clearance for it Access PCT Procalcitonin
Assay. The Access PCT assay enables healthcare providers to integrate procalcitonin
testing analysis into their routine sepsis workups on core laboratory analyzers, as a primary
or reflex test programmed though Beckman Coulter’s REMISOL Advance middleware.
Such integration simplifies laboratory workflow and optimizes institutional sepsis
management protocols while reducing the operational expense of maintaining costly
dedicated instrumentation.
In October 2020, the company received EUA for its Access Interleukin-6 (IL-6) assay from
FDA. Access IL-6 is a fully automated immunoassay designed to detect IL-6 levels in
serum and plasma which can be used to aid physicians identifying a severe inflammatory
response and determining the risk of intubation with mechanical ventilation in COVID-19
patients.
In July 2021, BC entered into an agreement with Quidel to obtain all rights to Triage BNP
assay for BC analyzers.
Microbiology
Beckman Coulter announced the commercialization of its DxM MicroScan WalkAway

system, a diagnostic solution for bacterial identification and antibiotic susceptibility testing
for microbiology laboratories. The DxM MicroScan WalkAway system uses direct

minimum inhibitory concentrations (MIC) for detection of antimicrobial resistance and of

emerging antimicrobial resistance (AMR).
Molecular Tissue Analysis
Beckman Coulter Life Sciences offers a menu of Agencourt reagent kits for nucleic acid
isolation, purification and cleanup. In January 2018, Beckman Coulter Life Sciences
launched a family of FormaPure reagent kits for extracting nucleic acid from often
challenging formalin-fixed, paraffin-embedded (FFPE) tissues. FormaPure reagent kits
represent a single chemistry system designed and optimized for use in next-generation
sequencing (NGS) and other downstream applications, including qPCR/ddPCR/PCR. The
family of reagent kits is made up of FormaPure Total for total nucleic acid isolation,
FormaPure DNA for DNA isolation and FormaPure RNA for RNA isolation.
Flow Cytometry
Beckman Coulter has been involved in flow cytometry since the mid-1970s and is a major
shareholder of this space with its competitor Becton Dickinson & Co. Flow cytometers are
part of the company’s Life Sciences business. Beckman Coulter offers research and
clinical models that take the best of legacy flow cytometers and set a new standard for more
compact, more versatile and more powerful instruments designed to make flow cytometry
more accessible for basic and high-end researchers alike.
For clinical applications, the “load and go” AQUIOS CL flow cytometer is designed for
high precision and integrated automated sample preparation. It delivers first results within
20 minutes for routine applications such as immunophenotyping.
Beckman Coulter added AQUIOS Designer Software to the AQUIOS CL Flow Cytometer.
The AQUIOS Designer Software allows for the creation of customer-defined applications
to be run on an instrument that combines sample preparation and flow cytometry analysis in
one platform (AQUIOS Load & Go technology). Until recently, this feature combination
was only available for pre-defined applications like CD4 analysis and basic
immunophenotyping.
Beckman Coulter received FDA clearance to market its ClearLLab Reagents (T1, T2, B1,
B2, M) to be used with flow cytometry to help diagnose numerous rare blood cancers,

including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma,

myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN). The
ClearLLab test not only detects cancerous cells in blood, bone marrow and lymph nodes,
but also provides information on the type of leukemia or lymphoma.
On the small footprint, AQUIOS CL Flow Cytometer, sample loading is similar to that of a
hematology analyzer, with integrated automated sample preparation. It delivers first results
within 20 minutes for routine applications such as immunophenotyping.
Beckman Coulter Life Sciences launched the first flow cytometer to offer excitation
sources across the visible spectrum in a standard configuration. The CytoFLEX LX Blue-
Red-Violet-Yellow Green-Ultraviolet-Infrared series incorporates excitation sources from
ultraviolet 355 nm to infrared 808 nm alongside the existing Avalanche photodiode
detectors (APD). While flow cytometry is recognized as a powerful technique for single
cell analysis, Beckman Coulter reports that the CytoFLEX LX opens up research into cell-
cell interactions under both normal and abnormal conditions.
In January 2019, Beckman Coulter launched the ClearLLab 10C System for clinical flow
cytometry labs that includes the first 10-color CE-IVD panels of immunophenotyping
reagents for both lymphoid and myeloid lineages. The four ClearLLab 10C panels are
designed specifically to run on Beckman Coulter’s Navios and Navios EX flow cytometers,
with new, advanced Navios compensation setup software. The ClearLLab 10C System is
an integrated solution, offering labs standardized workflow.
Alongside the panels, the integrated ClearLLab 10C system comprises ClearLLab Control
Cells, a liquid preparation of stabilized human erythrocytes and leukocytes (lymphocytes
monocytes and granulocytes) - the first application-specific IVD control cells for L&L
immunophenotyping as part of a validated system (according to Beckman Coulter).
The ClearLLab 10C System incorporates the company’s new Kaluza C software to
streamline and standardize clinical QC reporting to international guidelines. With the
ClearLLab 10C System, laboratories now have a portfolio of flow cytometric tools -
enabling them to provide accurate patient results for L&L analysis in a compliant lab
setting, without needing to carry out extensive manual validation, preparation and QC
tasks.
In October 2020, BD was granted FDA clearance for BD FACSLyric Flow Cytometer with
newly integrated BD FACDuet sample preparation system. The integrated system enables

clinical laboratories to fully automate the sample to answer process and improve their
efficiency by reducing errors and limiting the manual user interactions required to run
assays on the BD FACSLyric Flow Cytometer.
Beckman Coulter Life Sciences
In January 2019, Beckman Coulter Life acquired privately held liquid handling firm
Labcyte (San Jose, CA). Labcyte has developed an acoustic droplet ejection technology
called Echo that uses sound energy for the contactless transfer of samples and reagents.
In March 2019, Beckman Coulter Life Sciences entered into a partnership with Apostle Inc.
(Menlo Park, CA) for the launch of Apostle MiniMax High Efficiency Cell-Free DNA
Isolation Kit, a magnetic nanoparticle-based kit to extract circulating free DNA (cfDNA)
from plasma using manual or automated workflows. Apostle is dedicated to fundamentally
improving the accuracy and efficiency of liquid biopsy in early cancer detection or other
clinical applications, such as non-invasive prenatal testing (NIPT) and tests for infectious
diseases.
COVID-19
In June 2020, Beckman Coulter received CE marking and FDA EUA authorization for its
SARS-CoV-2 IgG Antibody Test.
In October 2020, the company received EUA from FDA for its Access SARS-CoV-2 IgM
assay. The assay detects antibodies that recognize the receptor binding domain (RBD) of
the spike protein which the SARS-CoV-2 virus uses to enter the human host cells.
In November 2020, BC launched its Access SARS-CoV-2 IgG II assay that measures a
patient’s relative level of antibodies in response to a previous SARS-CoV-2 infection.
In December 2020, the company launched its Access SARS-CoV-2 Antigen assay. The test
is one of the first high-throughput COVID-19 tests available in the US. It is designed for
mass testing.
In February 2021, BD was granted FDA EUA and CE Mark for a new molecular test for
both SARS-CoV-2 and Influenza A&B that can provide results in two to three hours. The
BD SARS-CoV-2/Flu assay is run on the BD MAX System and distinguishes between

SARS-CoV-2 and Influenza A+B, providing a positive or negative result for each virus
using a single specimen. Also, BD announced a collaboration with Scanwell Health to
create an at-home rapid test for SARS-CoV-2 using a BD antigen test and the Scanwell
Health mobile app.
In March 2021, BD entered into a collaboration with ImageMaker for rapid antigen test
reporting. ImageMaker is a software platform that automates and simplifies medical data
collection and management. The product is used to provide more streamlined reporting of
SARS-CoV-2 antigen testing results performed on the BD Veritor Plus System.

Becton, Dickinson and Company (BD)
Franklin Lakes, NJ
www.bd.com
Table 4-6: BD Diagnostic Revenues 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Diagnostic Revenues $2,288 $2,506 $2,517 $3,698 $4,345
Note: FY ends September 30

Flow cytometry revenues are not reported in BD’s diagnostic systems segment. Kalorama
estimates that there is little significant change in the company’s flow cytometry revenues
since 2015.
Table 4-7: Global BD Revenues in Flow Cytometry 2017- 2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Flow Cytometry $960 $970 $970 $906 $1,065
Becton Dickinson (BD) is a global medical technology company that develops,

manufactures and sells medical devices, instrument systems and reagents. Founded in 1897
and headquartered in Franklin Lakes, New Jersey. The company serves healthcare
institutions, life science researchers, clinical laboratories, the pharmaceutical industry and
the general public. BD has operated in China since 1994 and in India since 1996.
BD Diagnostics’ menu includes products for the collection and transport of diagnostics
specimens, as well as instruments and reagent systems to detect a broad range of infectious
diseases, healthcare-associated infections (HAIs) and cancers. Products include
microorganism identification and drug susceptibility systems, liquid-based cytology
systems for cervical cancer screening and HPV testing, rapid immunoassays, microbiology
plated media, microbiology laboratory automation, automated blood culturing systems and
molecular testing systems for infectious diseases and women’s health.
In May 2021, the company announced intention to spin off its diabetes care business and it
is expected to be completed in the first half of 2022.
In July 2021, BD launched a new bdbiosciences.com web and eCommerce site, an entirely
"reimagined" digital marketplace designed to provide an enhanced online purchasing
experience for users and their procurement teams.
Becton Dickinson announced that it would spin off its diabetes care business in May 2021.
In February 2022, the company named its new spin off Embecta, which launched in April
2022. BD retains no ownership interest in Embecta.

Cytology
BD offers comprehensive cervical cancer screening solutions that include BD Onclarity

HPV Assay, BD SurePath Pap Test and BD Totalys System processing automation. The
BD Viper LT System is part of the BD Totalys System, which automates cervical cancer
screening including BD SurePath Pap Test slide preparation, imaging and slide review,
combined with automated aliquot capabilities for ancillary testing.
In February 2018, BD received FDA clearance to market the Onclarity HPV assay
molecular test to detect 14 high-risk types of human papilloma virus. The assay is designed
for specimens collected in the BD SurePath liquid-based cytology vial for cervical cancer
screening. The test is clinically validated for use as a primary screening test, for triaging
patients with abnormal Pap test results, and to be used in combination with a Pap test.
The Onclarity HPV test is performed on the BD Viper LT system, which also runs FDA-
cleared tests for chlamydia and gonorrhea infection. BD reported that the test conforms
with clinical screening guidelines from the American Cancer Society, the American Society
for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology.
In July 2020, BD received FDA approval for BD Onclarity HPV Assay. The test broadens
the genotyping capabilities. The PMA supplement includes the expansion for genotype
reporting beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58,
35/39/68, and 56/59/66 genotypes making the BD Onclarity HPV Assay the only FDA-
approved assay to individually identify and report these genotype results.
Molecular Microbiology
The main player in BD’s products for molecular microbiology is the BD MAX System, a
fully integrated, automated platform that performs nucleic acid extraction and real-time
PCR providing results for up to 24 samples across multiple syndromes in less than three
hours. The BD MAX menu includes syndromic panels for health care associated
infections, reproductive and sexually transmitted infections and enteric pathogens. The BD
MAX system automates real-time PCR testing by performing the necessary steps of sample
extraction, amplification and detection on a single system. It also features open system
capability, allowing for the automated performance of in-house molecular assays.

The BD MAX system menu includes tests for antimicrobial resistance, syndromic panels
for gastrointestinal infections, as well as reproductive and sexually transmitted infections.
The instrument also features an open system capability, allowing for streamlined workflow
of laboratory developed tests and for additional assays via BD partner collaborations.
The BD MAX enteric suite of molecular tests for the detection of gastrointestinal bacteria,
parasitic or viral pathogens enable clinicians to perform targeted testing for patients based
upon their symptoms and health history or exposure. This testing approach is supported by
the Infectious Diseases Society of America (IDSA) guidelines. According to BD,
compared to more generalized tests, this test provides the most clinically useful and
necessary information to better diagnose and treat patients.
Traditional Microbiology - ID/AST
BD markets an extensive portfolio of microbiology solutions designed as integrated, end-

to-end offerings. The BD Bactec systems provide a full-spectrum blood culture offering for
all three phases of testing – sampling, culture, analysis.
BD offers growth media with more than 180 years of combined expertise with BD Difco
and BD BBL brand products.
BD offers multiple platforms for identification and susceptibility (ID/AST) testing,

including the BD Phoenix system, the BD Bruker MALDI biotyper and BD BBL Sensi-
Disc products.
BD has developed near-patient testing solutions for rapidly detecting a wide range of
pathogens including respiratory syncytial virus (RSV), influenza A+B and group A
streptococcus (GAS). The tests are run on the BD Veritor Plus system, a digital
immunoassay system that provides lab-quality test results for point-of-care testing within
minutes.
For serology testing, BD offers a variety of serology-based testing kits. BD Directigen

rapid immunoassay kits are available for the direct and qualitative detection of antigens.
BD reagents for syphilis testing include direct immunofluorescent reagents, FTA-ABS test
reagents, RPR kits and VDRL antigen.

BD offers a broad line of microbiology reagent droppers, diagnostic kits, antigens and
antisera, and Strep grouping products.
BD swab-based specimen collection systems are designed for optimal collection and
organism recovery.
In July 2020, BD launched the next generation microbiology solution for liquid and non-
liquid sample processing with the BD Kiestra InoquIA system.
In May 2021, BD announced the U.S. collaboration of a Urine Culture Application for use
with BD Kiestra lab automation incubation and imaging system. Designed using artificial
intelligence (AI) and leveraging the quality of BD BBL plated media, the application uses
digital imaging and software algorithms to determine the amount of growth on a urine
culture plate from clean caught and catheterized samples
Blood Culture
Even with the development of molecular assays for the most prevalent pathogens linked to
hospital acquired infections and sepsis, blood culture remains the most important
microbiology tool in the management of sepsis. BD and bioMérieux dominate this test
segment. The BD BACTEC blood culture system is designed to diagnose bloodstream
infections with a range of blood culture media and instrumentation. Coupled with a wide
variety of culture media formulations, BD provides screening for microorganisms present
in blood and blood components. BD BACTEC FX instruments powered by BD Synapsys
microbiology informatics allow laboratories to track samples and report results with an
intuitive, browser-based interface.
BD provides a proven, full-spectrum blood culture offering for all three phases of testing:
• Blood culture collection products for the preanalytical phase
• Blood culture instrumentation: BD’s BACTEC FX blood culture instrumentation

allows for simple, rapid workflow across multiple sites of the healthcare system. A
modular design provides workflow efficiencies to meet different volume needs
during the analytical phase with a full spectrum of blood culture instrumentation
solutions.

• BD BACTEC blood culture media offer efficient detection and increasing recovery
of aerobes, anaerobes and yeast.
• BD Synapsys IT solution for blood culture reporting and analytics offers integrated
workflow and on-demand insights to expedite decision-making and metrics during
the post-analytical phase with a full spectrum of blood culture workflow
management solutions.
• BD reported: “From FDA-cleared platelet testing media to advanced informatics,

BD now offers an integrated, culture-based solution to help meet the platelet quality
control testing requirements of clinical microbiology laboratories.”
In April 2019, BD announced the global availability of FDA cleared and CE Marked BD
BACTEC platelet quality control media, which allows microbiology laboratories, blood
banks and transfusion services to identify contaminated platelet units. BD BACTEC
platelet media provides a culture-based method to detect platelet contamination. The
product can be used for quality control testing of leukocyte reduced apheresis platelet
(LRAP) units, both leukocyte reduced single and a pool of up to six units of leukocyte
reduced whole blood platelet concentrates (LRWBPC). Testing platelet donations using
culture-based methods may help to reduce the risk of sepsis.
Hospital Acquired Infections
With the BD Max assays, BD BBL CHROMagar CPE plated media and BD Phoenix CPO
detect panels, BD provides comprehensive solutions for screening and infection
management to support clinical microbiology laboratories in their antimicrobial resistance
programs.
The BD Phoenix automated microbiology system provides identification and antibiotic

susceptibility testing of microbial organisms. In November 2018, BD received FDA
clearance to market the BD Phoenix CPO detect test, allowing hospitals to identify
infections caused by carbapenemase-producing organisms (CPOs). The test may help
hospitals contain the spread of antimicrobial resistance (AMR) by shortening the time it
takes to detect CPOs, thereby enabling the earlier implementation of infection control
procedures and the initiation of appropriate antibiotic therapies designed for treating these
infections.

The BD Phoenix CPO detect test is available as part of the BD Phoenix automated
microbiology system that can detect CPOs in less than 36 hours. BD reported: “Along with
the BD PhoenixM50 instrument, this automated first-to-market, phenotypic test to detect
CPOs, using the BD Phoenix system, expands the BD portfolio of solutions for
identification and antimicrobial susceptibility testing.”
Blood Collection
PreAnalytiX, a joint venture between BD and QIAGEN develops, manufactures and sells
integrated and standardized systems for sample collection, stabilization and purification of
high-quality RNA, microRNA and DNA from human blood, bone marrow, or tissue
specimens. The company serves healthcare institutions, academic researchers, clinical
laboratories and the pharmaceutical industry with a broad array of manual and automated
products.
In February 2020, BD entered into a partnership with Babson Diagnostics to make

diagnostic blood testing more accessible and convenient. The partnership builds on a
collaboration between the two companies dating back to 2017. Its goal is to enable retail
pharmacies to offer laboratory-quality diagnostic testing through Babson Diagnostics’
service by combining BD’s innovative capillary blood collection device in development
with Babson Diagnostics’ proprietary automated sample handling and analytical
technologies, which are also in development.
Mass Spectrometry
Since 2010, BD has provided Bruker with the essential microbiology aspect for its MALDI
mass spec clinical offering. BD and Bruker formed a co-development and co-marketing
agreement for microbial identification technologies that combined Bruker's MALDI
Biotyper system with BD's Phoenix Microbiology System. The agreement was expanded
in 2013 to include international distribution of the co-labeled BD Bruker MALDI Biotyper
system.
In April 2017, BD announced an expanded distribution agreement for various of Bruker's

mass spectrometry-based microbiology products including Bruker's MALDI Biotyper
Biotargets; disposable MALDI plates suitable for multiple uses; its MALDI Sepsityper, a

sepsis management kit; and its MALDI Biotyper smart, a faster, higher-throughput version
of the Biotyper platform that Bruker released in 2015.
Connectivity between the BD Bruker MALDI Biotyper, the BD Phoenix M50 v and BD
EpiCenter, a data management system, provide a comprehensive ID/AST solution.
BD stated “By directly offering MBT Biotargets and MBT Sepsityper, as well as standard
reagents and other products, BD completes a comprehensive mass spectrometry solutions
suite. MBT Biotargets are disposable plates that can be run multiple times, reducing waste.
MBT Sepsityper enables pathogen identification from positive blood cultures, eliminating
the time-consuming step of culturing the micro-organisms.”
Flow Cytometry
BD has a 40-year history of providing solutions for single cell analysis using flow
cytometry and is the leader in this market segment. BD has reported it is dedicated to
developing flow cytometry testing applications for clinical diagnostics.
BD received FDA clearance to market the BD FACSVia system, a flow cytometer system
with a leucocount reagent assay (BD Leucocount kit) that is used for identifying and
counting rWBCs (residual WBCs) in leucoreduced blood products.
BD received FDA clearance to market the BD FACSLyric flow cytometer system, an IVD
system, for use with BD Multitest assays for immunological assessment of individuals and
patients having or suspected of having immune deficiency.
The flow cytometer system combines a benchtop-sized instrument that supports the BD
Multitest 4-Color assays and the BD Multitest 6-Color TBNK assay, which are some of the
most used flow-based IVD assays (according to BD). These tests determine the percentages
and absolute counts of T, B and natural killer (NK) cells, as well as the CD4 and CD8
subsets of T cells. Together, these metrics can be used in the immunological assessment of
individuals and patients having, or suspected of having, immune deficiency.
BD Life Sciences – Biosciences and FlowJo, LLC (Ashland, OR) announced a partnership
to combine the BD generated cytometry data acquisition software with FlowJo's data
analysis platform. The combined software facilitates uploading of collected data from BD
flow cytometers running BD FACSDiva software, directly to FlowJo Enterprise. According

to BD, this allows researchers to link flow cytometry data acquisition to final results and
reports.
BD launched the BD Rhapsody platform for single cell analysis. The product was
previously in limited commercial release under the name Resolve, with application-specific
targeted panels to be offered alongside the ability for customers to design their own
custom-made targeted panels. Developed using the company’s patented unique molecular
index (UMI) technology, BD Rhapsody is a complete system of reagents, instruments and
software for targeted gene expression analysis of tens of thousands of individual cells. BD
offers both application-specific targeted panels and enable customers to design their own
custom, targeted panels. The platform is also being expanded beyond RNA expression to
include protein detection, leveraging BD’s extensive antibody portfolio with BD AbSeq
assays for protein expression.
In April 2018, BD launched the BD FACSymphony S6 cell sorter that offers six-way
sorting and supports analysis of up to 30 parameters. The new platform leverages the high
parameter capabilities of the BD FACSymphony cell analyzer, giving researchers the
ability to sort cell populations to better understand cell phenotypes for immunology and
multi-omics research.
In March 2019, BD was awarded the CE-IVD Mark for the BD FACSDuet automated flow
cytometry system. The fully automated sample preparation limits the manual user
interactions required to run assays on the BD FACSLyric clinical flow cytometer. Physical
integration between the BD FACSDuet system and the BD FACSLyric clinical flow
cytometer allows technicians to load samples and reagents onto the BD FACSDuet system
and receive data once the samples are fully processed from the BD FACSLyric clinical
flow cytometer. Data integration using the BD FACSLink middleware solution, offers
bidirectional communication between the instruments and connectivity with laboratory
information systems.
In October 2020, BD was granted FDA clearance for BD FACSLyric Flow Cytometer with
newly integrated BD FACDuet sample preparation system. The new integrated system
enables clinical laboratories to fully automate the sample to answer process and improve
their efficiency by reducing errors and limiting the manual user interactions required to run
assays on the BD FACSLyric Flow Cytometer.

COVID-19
BD and CerTest Biotec announced that the VIASURE SARS-C-V-2 RealTime PCR
Detection Kit adapted for the BD MAX system has been CE marked. The test is for the
detection of COVID-19.
In April 2020, BD and partner BioGX have FDA EUA authorization for the BIOGX
molecular test for the BD MAX system. Additionally, the company and BioMedomics
launched a rapid serology test to detect exposure to COVID-19 in about 15 minutes.
In July 2020, BD launched an FDA EUA authorized portable, rapid antigen test to detect
COVID-19. The new immunoassay test joins a portfolio of three molecular solutions for
COVID-19 testing that have been registered for use with the BD MAX Molecular System,
including two with FDA EUAs and two with CE mark. The BD Veritor Plus System for
Rapid Detection of SARS-CoV-2 Assay is deemed to be a CLIA-waived immunoassay
designed to be used in health care settings to provide an aid to rapid diagnosis of COVID-
19 in symptomatic individuals. The new assay delivers results in 15 minutes on an easy-to-
use, highly portable instrument, thereby improving access to COVID-19 diagnostics as it
enables real-time results and decision-making while the patient is still onsite. In September
2020, the company received CE mark for the portable BD Vector Plus System.
In October 2020, BD and partner, CerTest Biotec received CE mark for ViraSure SARS-
CoV-2 Real Time PCR Detection Kit adapted for the BD MAX System. his kit allows BD
MAX System users to run a single module that tests concurrently for COVID-19 and
influenza and respiratory syncytial virus (RSV). The new CerTest kit provides rapid
COVID-19 diagnostic capabilities that can be run individually or combined with detection
of Flu A, Flu B and RSV A and B.
In February 2021, BD received EUA and CE Mark for its BD MAX System for
combination molecular diagnostic to detect sARS-CoV-2 and Influenza A+B in a single
test.
Additionally, in February 2021, BD entered into a collaboration with Scanwell Health to

create an at-home rapid test for SARS-CoV-2 using a BE antigen Test and the Scanwell
Health mobile app. BD plans to produce a lateral flow antigen test and pair it with the
Scanwell Health mobile app. The app is expected to provide step-by-step instructions on
how to collect and transfer a nasal swab sample and use the mobile device's camera to
analyze and interpret results. The test results are displayed onscreen, and the companies are

also planning to develop functionality to assist in automated reporting to public health

agencies. This approach is intended to provide an efficient and scalable rapid antigen home
testing solution.
In March 2021, BD entered into a collaboration with ImageMover to offer a companion

mobile app that enables more streamlined reporting of SARS-CoV-2 antigen testing results
performed on the BD Veritor Plus System.
In March 2021, BD received FDA EUA for combination COVID-19, Influenza A and
Influenza B on the BD Veritor Plus System. This can be done is a single test.

bioMérieux
Marcy-l’Étoile, France
www.biomerieux.com
Table 4-8: bioMérieux IVD Revenues, 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Total IVDs $2,091 $2,348 $2,473 $3,042 $3,995
In 2021 bioMérieux it is estimated that sales in the Americas totalled 49% of total sales.
(44% North America; 5% Latin America)

The following is an estimate of bioMérieux's IVD product revenue in selected test

segments:
Table 4-9: bioMérieux Revenues in Selected Test Segments, 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Microbiology $1,069 $1,090 $1,149 $1,085 $1,257
Immunoassays $597 $597 $532 $488 $541
Molecular $517 $646 $752 $1,380 $1,500
Other Molecular $7 $38 $40 $89 $113
Film Array $416 $570 $630 $1,201 $1,330
bioMérieux is present in more than 160 countries through 40+ subsidiaries and a large
network of distributors. For clinical diagnostics, bioMérieux provides diagnostic solutions
(reagents, instruments, software) that are used for diagnosing infectious diseases, blood
bank screening, blood culture, for cancer screening and monitoring and for cardiovascular
emergencies.
bioMérieux is best known for its microbiology business that includes immunoassays,
traditional microbiology and chromogenic media; however, the company is moving to
capitalize on its acquisition of Organon Technika’s molecular technology, BOOM and
NASBA technologies. Most of those patents expired in 2010. bioMérieux is working to
establish a strong market presence in molecular diagnostics.
Traditional Microbiology
In the area of routine bacterial identification and antibiotic susceptibility testing (ID/AST),
bioMérieux claims to be a market leader with its VITEK 2 instrumentation. Results can be
obtained as quickly as 3 to 7 hours thanks to the combination of analysis software and an
original, miniaturized consumable, the VITEK 2 card, which is available for a wide range
of antibiotics. VITEK 2 identifies the vast majority of routine organisms (over 300
microorganisms).

Blood Culture
bioMérieux and Becton Dickinson are the major venders of blood culture systems.
bioMérieux has been a major player in microbiology and has put together a comprehensive
menu to tackle sepsis and hospital acquired infections (HAI) one of the most pressing
problems in healthcare. The toolbox includes the BacT/ALERT Virtuo blood culture
platform, the procalcitonin (PCT) immunoassay, and a toolbox of molecular testing tools
including the BioFire FilmArray Blood Culture Identification (BCID) assay test menu and
the Vitek MS MALDI-TOF mass spec system, which perform automated identification
testing within minutes. The goal is to aid in the rapid pathogen identification and
appropriate antibiotic therapy.
bioMérieux has developed the BacT/ALERT Virtuo for blood culture detection. The
company indicated the system could fit into any size lab, even outside the routine
microbiology lab. Linked to the Myla software BacT/ALERT Virtuo integrates the blood
culture workflow to the lab information system. bioMérieux reports that the
BACT/ALERT technology is in routine use by blood collection and transfusion facilities in
over 25 countries worldwide and has a long-proven track record for testing platelets.
BACT/ALERT VIRTUO is a fully automated microbial detection system with motion-

activated loading and unloading of bottles. It offers proprietary algorithms, high thermal
stability and sensitive optics, which enhance performance for more rapid time to detection
if microbial contaminants are present.
The FDA cleared and CE Marked system is commercially available to blood banks and
transfusion services in the U.S., Europe and in countries that recognize CE marking.
bioMérieux received FDA clearance for its culture bottles BACT/ALERT BPA and BPN
for quality control testing of leukocyte-reduced apheresis platelet (LRAP) units with the
BACT/ALERT VIRTUO fully automated blood culture system. These bioMérieux quality
control solutions can be used to extend platelet shelf life up to a total of seven days.
Immunoassays
bioMérieux markets the VIDAS line of automated immunoassay systems, worldwide

(VIDAS automated immunoassay platforms – VIDAS, mini VIDAS and VIDAS 3.) .
These systems offer multi-parameter instruments using ELFA (Enzyme Linked Fluorescent

Assay) technology, based on a ready-to-use single-sample test concept. The analyses may
be run in a batch or in random access.
In February 2021, the company received CE marking for its NEPHROCHECK assay that is
used to detect kidney stress in patients at risk of AKI.
In March 2021, the company received CE marking for its VIDAS TB IGRA assay to
diagnose latent TB infections.
In April 2021, the company received CE marking for three dengue immunoassays on
VIDAS – VIDAS DENGUE NS1 Ag, VIDAS Anti-DENGUE IgM and VIDAS Anti-
DENGUE IgG.
BIOFIRE Diagnostics Business
At the time the company was acquired, the FilmArray test portfolio included four FDA
cleared and CE-Marked panels:
• BIOFIRE FILMARRAY Respiratory Panel: tests for a comprehensive panel of 20

respiratory viruses and bacteria.
• BIOFIRE FILMARRAY Blood Culture Identification Panel: tests for 24 pathogens

and 3 antibiotic resistance genes associated with bloodstream infections.
• BIOFIRE FILMARRAY Gastrointestinal Panel: tests for 22 common

gastrointestinal pathogens including viruses, bacteria and protozoa that cause
infectious diarrhea.
• BIOFIRE FILMARRAY Meningitis Encephalitis Panel: tests directly in Cerebral

Spinal Fluid for the 14 most relevant ME-associated pathogens, including bacteria,
viruses and a parasite.
In January 2020, the company submitted the enhanced BIOFIRE BCID2 panel for FDA
clearance.
In July 2020, the company launched the BIOFIRE Mycoplasma, an innovative test for
mycoplasma detection. It is a rapid molecular test.

COVID-19
bioMerieux delivered three diagnostic tests - SARS-CoV-2 R-GENE test, the BioFire
SARS CoV-2 and BioFire RP2.1 tests. In addition, a fully-automated test based on the
BioFire FilmArray technology is being developed with the support of the US Department
of Defense. This test is specifically designed to detect SARS-CoV-2 and is designed to run
on FilmArray 2.0 and FilmArray ToRCH platforms.
In March 2020, bioMerieux received EUA authorization for its BioFire COVID-19 test for
use in CLIA moderate and high complexity clinical labs. The BioFire COVID-19 test
detects SARS-CoV-2 in approximately 45 minutes from a nasopharyngeal swab in
transport media. This test runs on the fully automated FilmArray 2.0 and FilmArray
ToRCH platforms and is extremely easy to use, therefore requiring minimal training and
skills in molecular biology.
In May 2020, the company received EUA authorization for its BioFire Respiratory Panel
2.1 with SARS-CoV-2. Additionally, in May 2020, bioMerieux received CE marking for its
serology tests for SARS CoV-2 test on VIDAS. VIDAS anti-SARS-CoV-2 IgM and anti-
SARS-CoV-2 IgG are used to measure the presence of antibodies in people who have been
infected with SARS-CoV-2. In this context, clinical specificity is particularly important to
ensure that testing of uninfected individuals consistently delivers a negative result. Both
VIDAS anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG provide results in less than 30
minutes.
In July 2020, the company received CE Mark for its BioFire Respiratory Panel 2.1 Plus.
The ARGENE SARS-CoV-2 R-GENE was launched in March 2020, followed by the US
FDA EUA cleared Biofire RP2.1 panel and the VIDAS anti-SARS- CoV-2 IgM and anti-
SARS-CoV-2 IgG tests. The Biofire Respiratory Panel 2.1 Plus (RP2.1plus) tests for 23
pathogens (19 viruses, including SARS-CoV-2, and four bacteria) which are responsible for
the most frequent respiratory tract infections. The new panel advances the existing Biofire
Respiratory Panel 2 Plus (RP2plus) by adding SARS-CoV-2 to the panel menu while
maintaining an assay runtime of about 45 minutes.
In November 2020, bioMerieux expanded its ARGENE range for detection of SARS-CoV-
2. The test may now be used on saliva and oropharyngeal swab specimens. Additionally, in
December 2020, the ARGENE test received CE marking for the simultaneous detection of
SARS-CoV-2, influenza A+B and RSV and hMPV.

In March 2021, bioMerieux obtained FDA De Novo authorization for its BIOFIRE RP2.1
Panel. The panel detects 22 viral and bacterial pathogens responsible for respiratory
infections including SARS-CoV-2.

Bio-Rad Laboratories, Inc.
Hercules, CA
www.bio-rad.com
Table 4-10: Bio-Rad Diagnostics Revenues 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Total IVDs $1,361 $1,412 $1,412 $1,305 $1,515
Bio-Rad generated 34% of product sales in the EU, 39% in the U.S. & Americas, and
21.5% in Asia Pacific.

The following is an estimate of Bio-Rad’s revenues in selected clinical lab product

segments:
Table 4-11: Global Bio-Rad Revenues in Selected Test Segments 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Immunoassays $315 $330 $328 $260 $294
Microbiology (all) $245 $250 $240 $223 $316
Blood Bank $340 $350 $375 $352 $362
Digital PCR $33 $36 $39 $39 $62
Quality Control $418 $426 $430 $431 $481
Founded in 1952, Bio-Rad Laboratories, Inc. markets a broad range of products for the life
science research and clinical diagnostic markets. The company offers more than 3,000
different products that cover more than 300 clinical diagnostic tests to clinical diagnostic
customers include hospital laboratories, reference laboratories, transfusion laboratories and
physician office laboratories.
Bio-Rad's growth comes from its strength in multi-niche markets including infectious
disease immunoassays, diabetes hemoglobin A1c, autoimmune immunoassays, neonatal
screening, allergy testing, blood typing, microbiology media and pathogen identification
tests, and quality control products.
In April 2020, Bio-Rad acquired Celsee, a single-cell analysis solution provider. Celsee’s
Genesis System offers a practical, scalable, and efficient approach to accurately analyze
single cells.
In June 2021, Bio-Rad announced a partnership with Seegene for the clinical development
of infectious disease molecular diagnostic products. Seegene provides diagnostic tests for
use on Bio-Rad’s CFX96 Dx Real Time PCR System.

Blood Bank
Bio-Rad provides a wide variety of platforms, reagents, data management, and connectivity
solutions to address different blood typing needs, including blood grouping, phenotyping,
crossmatching, antibody screening and identification, direct antiglobulin tests, and single
antigen typing. Bio-Rad’s blood banking product portfolio includes the IH-System Gel
Reagents for automated and manual blood typing methods.
Using Bio-Rad’s IH-Com patient data management software and IH-Web remote results
management interface, the IH-500 and other Bio-Rad blood typing and screening
instruments can be seamlessly integrated to help laboratories manage their blood testing
workload.
In April 2019, Bio-Rad received FDA clearance to market the IH-500 system, an automated
random-access system for blood typing and screening. The IH-500 system was designed
for small- to medium-size laboratories, offering automated blood typing and screening
based on gel card technology with minimal user intervention. The system can process Bio-
Rad’s entire range of IH gel cards for ABO blood grouping, reverse testing, phenotype, Rh-
subgroups, antibody screening, antibody identification, single antigen testing, direct AHG
testing (DAT), and crossmatch.
In April 2019, the company received clearance for the IH-500. The IH-500 system was
designed for small- to medium-size laboratories, offering automated blood typing and
screening based on gel card technology with minimal user intervention. The system can
process Bio-Rad’s entire range of IH gel cards for ABO blood grouping, reverse testing,
phenotype, Rh-subgroups, antibody screening, antibody identification, single antigen
testing, direct AHG testing (DAT), and crossmatch, to deliver safe and accurate results.
Diabetes
Bio-Rad brings over 40 years of expertise in diabetes testing as an early marketer of HPLC-
based benchtop instrumentation. One of the company’s newest products is the D-100
System, which aids in the diagnosis and monitoring of diabetes. The D-100 features Smart
HPLC, designed to meet the quality and productivity demands of high-volume labs. Bio-
Rad's onboard Advisor software automatically reviews results.

In November 2020, the company introduced new features to its D-10 Hemoglobin testing
system to better manage patient results. The D-10 offers fully automated diabetes and beta
thalassemia testing on a single platform.
Immunoassays
Bio-Rad Laboratories’ Bio-Plex assays are built around the Luminex xMAP technology
using a bead-based flow cytometric platform dedicated to multiplex analysis. Assays are
available for many classes of biomolecules and species including cytokines and growth
factors, and as specialized disease state panels such as cancer, acute phase immune
response, and diabetes markers. An extensive menu of autoimmune and infectious disease
assays has been developed for use on the BioPlex 2200 System. The BioPlex 2200 System
provides clinical laboratories the capability to multiplex or run multiple individual tests that
are traditionally processed separately. The following are additions to the company’s
immunoassay portfolio.
In April 2019, Bio-Rad received FDA clearance to market its BioPlex 2200 Lyme Total
Assay, a multiplex test method to aid in the diagnosis of Lyme disease. The Assay can
simultaneously detect multiple targets. The release of the BioPlex 2200 Lyme Total assay
is the latest offering in Bio-Rad's infectious disease menu for the BioPlex 2200 System, an
automated multiplex technology platform.
Bio-Rad reports that it has established a leading position in digital droplet PCR with its
acquisition of RainDance. According to Bio-Rad many researchers worldwide have
already adopted that droplet digital PCR platform and Bio-Rad is turning to develop liquid
biopsy opportunities on the RainDance platform.
In February 2019, Bio-Rad Laboratories received FDA clearance to market the QXDx
AutoDG ddPCR System, which uses Bio-Rad’s Droplet Digital PCR technology, and the
QXDx BCR-ABL %IS Kit. This is the company’s first liquid biopsy assay and Droplet
Digital PCR system for diagnostic use. The test is designed for monitoring treatment
response in chronic myeloid leukemia and is also the first-ever digital PCR product to
receive FDA clearance, according to the company. Used together, Bio-Rad’s system and
kit are designed to monitor molecular response to treatment in patients with chronic
myeloid leukemia (CML).

The test quantifies BCR-ABL fusions and can detect the residual levels seen in patients on
tyrosine kinase inhibitor therapy. Measuring residual levels of BCR-ABL in CML patients
treated with the first line TKI imatinib, for example, can help physicians decide whether it
might be necessary to start a second-line TKI, such as dasatinib, nilotinib, or bosutinib.
The test uses Bio-Rad's QXDx AutoDG ddPCR System for clinical applications. It is
designed to give users the flexibility to run FDA-cleared IVD tests as well as lab-developed
tests.
Bio-Rad company information stated that the FDA clearance of the firm's QXDx ddPCR
instrument and assay for CML is "really the first important step" in building the company’s
oncology menu focused on liquid biopsy and emphasized that users can develop lab-
developed tests on the QXDx instrument as well.
In February 2019, Bio-Rad launched the QXDx AutoDG ddPCR System into the US
market with FDA clearance.
COVID-19
Through the Exact Diagnostics product line, Bio-Rad launched its SARS CoV-2 Standard
for COVID-19 testing. The SARS CoV-2 Standard contains synthetic COVID-19 RNA
transcripts and human genomic DNA, allowing laboratories to test the entire process of a
molecular assay including extraction, amplification, and detection of the virus.
In April 2020, Bio-Rad launched a blood-based immunoassay kit to identify antibodies of

SARS-CoV-2. Bio-Rad's immunoassay kit detects total immunoglobulin (IgG, IgM, and
IgA), an approach which appears to be more sensitive than assays against a single
immunoglobulin. The test was designed for use manually or on an automated immunoassay
platform, such as Bio-Rad’s EVOLIS System, which offers high throughput processing and
sample traceability. The product has been granted EUA authorization by FDA.
In May 2020, the company received EUA authorization from FDA for Droplet Digital PCR
SARS-C-oV-2 Test Kit.
In September 2020, Bio-Rad launched VIROTROL SARS-CoV-2 and VIROCLEAR

SARS-CoV-2 serology controls for COVID-19 assay testing.

Cepheid / Danaher
Sunnyvale, CA
www.cepheid.com
Table 4-12: Cepheid Revenues 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Revenues $640 $800 $950 $1,882 $3,477
Cepheid reported that its core revenues have been growing in the low double digits year
over year. Sales increased in both the developed markets and the high-growth markets, as
well as across most major product lines. Infectious disease and sexual health revenues each
rose in the double digits.
Danaher reported that revenue growth can be partially attributed to improved commercial
execution across all major product lines and geographies. Continued strength in the high-
burden developing countries, as well as developed markets, also factored into Cepheid's
growth.
Cepheid is a molecular diagnostics company that is dedicated to easy-to-use molecular

systems and tests. The company focuses on managing infectious diseases and cancer.
Cepheid reported more than 20,000 GeneXpert systems are installed in 180 countries, with
customers including those operating in low-volume point-of-care settings and high-volume
reference laboratories. Using proprietary test cartridges, the GeneXpert menu offers 27
tests outside the U.S. and 20 tests in the U.S. including tests addressing the global
epidemics, HIV and HCV, on the same platform.
Cepheid’s GeneXpert System is a closed, self-contained, fully-integrated and automated

platform that combines on-board sample preparation with real-time PCR (polymerase chain
reaction) amplification and detection functions for fully integrated and automated nucleic

acid analysis. The system is designed to purify, concentrate, detect, and identify targeted
nucleic acid sequences thereby delivering answers directly from unprocessed samples.
GeneXpert Xpress Line
The Xpress line is a single-module CLIA-waived instrument for near-patient and point-of-
care settings, as well as two- and four-module instruments. Cepheid has obtained FDA
clearance and CLIA waiver for two multi-module platforms: GeneXpert Xpress II and
GeneXpert Xpress IV.
According to Cepheid, the Xpress tests rely on the same real-time PCR as the GeneXpert
molecular assays, but the Xpress line runs faster by altering the chemistry within test
cartridges. This test, which delivers results in 15- 30 minutes, replaces the previously
waived one-hour GeneXpert test and instrument. The instrument is available as a two- or
four-module system, the GeneXpert Xpress II or GeneXpert Xpress IV.
Cepheid received the FDA CLIA waiver for its near-patient assay Xpert Xpress Strep A test
to detect Group A Strep infection. In 2017, the test was cleared to run on the GeneXpert
molecular diagnostics platforms, including the GeneXpert Xpress II and GeneXpert Xpress
IV.
The Xpert Xpress Strep A test detects Streptococcus pyogenes DNA in as little as 18
minutes. The FDA approval also stipulated that there are no requirements for culture
confirmation of negative results unless clinical symptoms persist or in situations where
there is an outbreak of acute rheumatic fever.
Tuberculosis
Cepheid’s FDA cleared Xpert MTB/RIF test has become the go-to test for rapid
tuberculosis testing. The review decision was based on the de novo 510(k) review process,
which allows novel products without predicates to be down classified and brought to
market. Xpert MTB/RIF is designed for the rapid molecular detection of Mycobacterium
tuberculosis complex (MTB-complex) DNA and in specimens where MTB-complex DNA
is detected. Xpert MTB/RIF also detects rifampin-resistance associated mutations of the
rpoB gene. Test results are available in two hours.

The existing test, Xpert MTB/RIF, was introduced in 2010 and as of 2016, more than 23
million Xpert MTB/RIF tests have been procured in 130 countries. However, sensitivity of
Xpert MTB/RIF is imperfect in smear-negative and HIV-associated TB, and some
limitations also remain in the determination of rifampicin-resistance status using the
existing test. Ultra is a second-generation test that was designed to overcome the sensitivity
limitations of Xpert MTB/RIF. It was developed by Cepheid in collaboration with Rutgers,
with additional support from the U.S. National Institute of Allergy and Infectious Diseases
(NIAID), and FIND, with support from funders including the Governments of Australia
and the Netherlands, and UK Aid from the British People.
In July 2020, Cepheid released a new rapid molecular test for TB that can simultaneously
detect resistance to first and second-line drugs.
Microbiology
The Xpert Carba-R assay uses real-time polymerase chain reaction technology to detect
five of the most prevalent genes associated with carbapenemase, an enzyme produced by
CRE. The test does not detect the bacteria itself and is one of 20 proprietary tests approved
for use on the GeneXpert System. Cepheid received initial clearance for the Xpert Carba-R
assay in March 2016 for use with pure bacterial isolates, but this expanded clearance now
enables users to detect carbapenem resistance genes directly from rectal swab specimens.
Cepheid announced that particularly dangerous Clostridium difficile strains are now
potentially easier to detect, thanks to expanded reporting of binary toxin (CDT) gene
presence with the Xpert C. difficile BT test. The presence of binary toxin-producing C.
difficile has been linked to increased disease severity, mortality and disease r recurrence
specially when they are negative for toxins A and B but positive for binary toxin.
Cepheid was granted FDA clearance for expanded claims for the Xpert TV assay urine-
based test for Trichomonas vaginalis that delivers results in as little as 35 minutes.
Following initial clearance of Xpert TV for three types of female specimens in October of
2015, the latest clearance extends the range of potential uses of the assay, and positions
Xpert TV (according to Cepheid) as the only cleared molecular test for urine samples from
symptomatic and asymptomatic men.
Cepheid received FDA clearance to market the Xpert MRSA NxG, the next generation
methicillin-resistant Staphylococcus aureus (MRSA) infection control test from the leader

in healthcare-associated infection (HAI) testing. Xpert MRSA NxG is an accurate, on-

demand, molecular test that delivers actionable results in about an hour.
POC Testing
Cepheid reported the Xpert HCV Viral Load Finger Stick assay detected active infection
with HCV in point-of-care blood samples (source: The Journal of Infectious Diseases).
Further, the new hepatitis C virus finger-stick test can be used to diagnose infection in a
single clinical visit, delivering results in 1 hour. Also, the novel Xpert VL FS assay
provides a substantial advance over Cepheid’s Xpert HCV Viral Load assay, avoiding the
need for plasma separation and enabling testing and diagnosis in 1 hour as compared to 2
hours, increasing the potential to move toward a single-visit diagnosis.”
In May 2019, Cepheid received FDA clearance for testing throat and rectal specimens with
its Xpert CT/NG test. The test provides fast and accurate molecular detection of chlamydia
and gonorrhea.
Cancer
In October 2019, Cepheid announced that it has received clearance from the U.S. Food and
Drug Administration for Xpert BCR-ABL Ultra for monitoring disease burden in patients
with Chronic Myeloid Leukemia (CML). Xpert BCR-ABL Ultra, an in vitro diagnostic test,
is the first FDA-cleared test of its kind capable of delivering accurate molecular results
from whole blood samples in under 3 hours.
COVID-19
In February 2020, Cepheid and Sherlock Biosciences entered into a collaboration to

develop a molecular diagnostic test for COVID-19. Sherlock Biosciences' engineering
biology platform, SHERLOCK, a CRISPR-based technology, can identify virtually any
genetic target. New tests could be designed to run on Cepheid's GeneXpert Systems. The
collaboration focuses on molecular diagnostic tests for infectious diseases and oncology,
beginning with a proof-of-concept project focused on detection of coronavirus (SARS-
CoV-2).

In March 2020, Cepheid received EUA from FDA for Xpert Xpress SARS-CoV-2, which is
a rapid molecular diagnostic test. Cepheid currently has nearly 5,000 GeneXpert Systems in
the US capable of point-of-care testing and for use in hospitals.
In June 2020, Cepheid announced the development of a four-in-one combination test for
SARS-CoV-2, flu A, flu B and RSV. The Xpert Xpress SARS-CoV-2/Flu/RSV four-in-one
test is expected to deliver qualitative detection of SARS-CoV-2, Flu A, Flu B and RSV
from a single patient sample. The test is designed for use on any of Cepheid's more than
25,000 GeneXpert Systems placed worldwide, with results expected in as little as 35
minutes. Cepheid intends to pursue the FDA's Emergency Use Authorization (EUA)
pathway for regulatory authorization and make the test available globally on its cartridge-
based GeneXpert Systems, which features instruments that can be configured for both near
patient point-of-care and high-volume laboratory testing needs.
In September 2020, the company received FDA EUA for SARS-CoV-2, Flu A & B and
RSV combination test.
In October 2021, Cepheid received CE marking for Xpert Xpress CoV-2/Flu/RSVplus,

which is a rapid molecular test for qualitative detection of the COVID-19 viruses.
In June 2022, Cepheid received CE marking and FDA EUA for Xpert Xpress CoV-2plus.
The test is a rapid molecular test for the qualitative detection of COVID-19. The plus
portion of the test enables consistent virus detection incorporating a 3rd conserved genetic
target for SARS-CoV-2 detection.

Danaher Corporation
Washington, DC
www.danaher.com
Danaher divides it diagnostics segment into three units. The Clinical Lab Diagnostics unit
manufactures and markets instruments, reagents, supporting consumables, and software for
clinical chemistry, immunoassay, hematology, conventional microbiology, and molecular
testing. The Critical Care Diagnostics unit provides dedicated POC and laboratory systems
and rapid tests that measure critical parameters, such as blood gases, electrolytes, glucose,
metabolites and cardiac markers. The Anatomical Pathology Diagnostics unit produces a
full range of reagents and instruments for histology and cytology procedures, including
staining reagents, antibodies, and consumables; tissue embedding, processing and slicing
(microtomes) instruments; slide cover slipping and slide/cassette marking devices; slide
scanners, microscopes, and cameras; and software solutions for storing, sharing, and
analyzing pathology images.
Table 4-13: Danaher Diagnostics Revenues 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Total Diagnostics $5,840 $6,258 $6,561 $7,403 $9,844
Danaher reported that diagnostics revenues increased 33% in 2021 to $9.8 billion from $7.4
billion in 2021. During 2021, there was increased demand for molecular diagnostics and
acute care instruments and consumables due to the COVID-19 pandemic.

Figure 4-6: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated

Dexcom
San Diego, CA
www.dexcom.com
Table 4-14: 2017-2021 Dexcom Revenue History ($ million)
2017 2018 2019 2020 2021
Total Revenues $718 $1,032 $1,476 $1,927 $2,448
Total company revenues for 2021 reached $2,448 million an increase of approximately
27% over 2020’s $1,924 million. The increase in sales was due to increased sales volume
of the company's disposable sensors due to the continued growth of installed base
customers using the G4 Platinum, G5 Mobile systems and G6 systems.

Dexcom is a medical device company that specializes in the design, development, and
commercialization of continuous glucose monitoring (CGM) systems for use by people
with diabetes and by healthcare providers. The company conducts manufacturing activities
at its San Diego, CA headquarters facility and Mesa, Arizona.
In general, CGM systems from Dexcom consist of a sensor, transmitter, and receiver. The
sensor, about the width of two human hairs, is applied by the user to the abdomen with a
tiny, attached transmitter, which sends data wirelessly to a receiver or a compatible smart
device (e.g., a smart phone). The receiver processes the glucose signal and displays the
user’s current glucose value, as well as 1-, 3-, 6-, 12-, and 24-hour trends. Additionally, the
receiver issues an alert when a high- or low-glucose state is present.
Dexcom’s main products are the Dexcom G5 Mobile CGM System and the Dexcom G6
CGM System. The Dexcom G5 Mobile CGM System is designed to allow Dexcom’s
transmitter to run the algorithm that has historically operated on the receiver and to
communicate directly to a patient’s mobile digital device. Although the Dexcom G5
Mobile CGM System does not require confirmatory finger sticks when making treatment
decisions, the system requires a minimum of two finger sticks per day for calibration.
The US Food and Drug Administration (FDA) approved the Dexcom G5 Mobile CGM
System as the first and only CGM system that can be used to make daily diabetes treatment
decisions without finger pricking. This approval, which labels the system as non-
adjunctive, is a key step toward enabling Medicare recipients to have access to CGM
technologies, since non-adjunctive labeling is necessary for coverage by the Medicare
program.
Dexcom also offers Dexcom STUDIO CGM software and Dexcom CLARITY diabetes
management software. Dexcom STUDIO CGM software can generate reports showing
glycemic excursion patterns and highlight the most significant pattern of hyperglycemia
and hypoglycemia throughout the day and night, as well as frequency of occurrence.
The Dexcom G6 CGM System does not require finger sticks for either calibration or
diabetes treatment decisions. Other features of the system include one-touch, simple
insertion of the sensor; hypoglycemia prediction capabilities; and a 10-day wearable sensor
that lasts 43 percent longer than sensors accompanying the firm’s previous generation
CGM systems.

In March 2018, FDA approved marketing of Dexcom's G6 CGM System for people with
diabetes ages 2 and up. New features on the Dexcom G6 include:
• Fingerstick Elimination – No fingersticks are needed for calibration or diabetes

treatment decisions.
• Easy Sensor Applicator – Complete redesign of the sensor applicator allows for
one-touch, simple insertion.
• Discreet and Low Profile – A redesigned transmitter with a 28% lower profile than
previous generation Dexcom CGMs makes the device comfortable and easy to wear
under clothing.
• Acetaminophen Blocking – New feature allows for more accurate glucose readings
with no medication interference.
• Predictive Low Alert – New alert feature predicts hypoglycemia before it hits to
help avoid dangerous low blood sugar events.
• Extended 10-Day Sensor – 10-day sensor allows for 43% longer wear than previous
generation Dexcom CGMs.
In October 2019, received clearance from FDA for its Dexcom G6 Pro CGM for healthcare
professionals. Dexcom G6 Pro is the first and only single use, professional CGM that
gathers real-time glucose data over a 10-day period and offers both a blinded and unblinded
mode.
In July 2021, Dexcom received FDA clearance for its Real-Time API, which expands
connectivity and interoperability of the Dexcom system. Additionally, in July 2021, CE
marking was obtained for the Dexcom ONE CGM system. The product was launched in
four countries including Bulgaria, Estonia, Latvia, and Lithuania.
In March 2022, Dexcom received CE marking for its Dexcom G7 G System for people in
Europe. The new product features 30-minute sensor warm up, 12-hour grace period, 60
percent smaller wearable (developed in partnership with Verily), Clarity integration, direct
to Apple watch design. The Dexcom G7 is currently under FDA review.

Exact Sciences
Madison, WI
www.exactsciences.com
Table 4-15: Exact Sciences Revenue History, 2017-2021 (in $ millions)
2017 2018 2019 2020 2021
Total revenue $276 $454 $876 $1,491 $1,767
Revenues increased in 2021 reaching $1,767 million demonstrating an increase of 18.5%

over 2020’s $1,491 million. The company has continued to increase its revenues for its
lead product, Cologuard. For 2021, the Cologuard test revenues grew from $815 million
in 2020 to $1,062 million. Revenues increased in 2021 due to a full year of Precision
Oncology revenue, reaching $532 million in 2021 up from $440 million in 2020. In
addition to the regular revenue, the company secured $143 million from COVID-19 testing.
Figure 4-8: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions)estimated

Exact Sciences was founded in 1995 through a collaboration with the Mayo Clinic. In
December 2012, Exact Sciences submitted the first module of the premarket approval
application to the U.S. Food and Drug Administration for its multi-target stool DNA
colorectal cancer screening
In May 2019, Exact Sciences reported that its work with collaborator, Mayo Clinic, using
blood-based methylated DNA markers demonstrated a potential to achieve 92% sensitivity
for detecting the most common type of pancreatic cancer. The collaboration between the
Mayo Clinic and Exact Sciences is focused on identifying biomarkers for 15 of the
deadliest cancers.
In July 2019, Exact Sciences acquired Genomic Health. The combined companies offer two
of the strongest and fastest growing brands in cancer diagnostics, Cologuard and Oncotype
DX, providing a robust platform for continued growth. With this enhanced platform,
including a commercial presence in more than 90 countries, the combined company expects
to continue to increase adoption of current tests, and to bring new innovative cancer
diagnostics to patients throughout the world.
In September 2019, FDA granted approval for the use of Cologuard in individuals 45 to 49
years.
In November 2019, the company received FDA breakthrough device designation for liver
cancer. Exact Sciences is finalizing its HCC test development and plans to make the test
available in the second half of 2020. This helps generate real-world evidence to support
guideline inclusion, broad reimbursement, and adoption of the test over time.
In March 2020, Exact Sciences acquired Paradigm Diagnostics and Viomics. Paradigm
offered a comprehensive genomic profiling test for patients with advanced, refractory, or
recurrent cancer, allowing physicians to better understand a patient's tumor profile and
more effectively recommend targeted therapies or clinical trials. Viomics provided
extensive sequencing capabilities and expertise in identifying unique biomarkers that
indicate the presence of cancer in solid tissue and blood.
In October 2020, the company acquired Base Genomics, whose methylation analysis
technologies help to enhance the Cologuard test.
In October 2020, Exact Sciences and Pfizer extended their agreement to promote
Cologuard. Pfizer continues to provide marketing and related support for Cologuard.

Additionally, in October 2020, Exact Sciences introduced the Oncotype MAP Pan-Cancer
Tissue Test.
In January 2021, Exact Sciences acquired Thrive, a developer of blood-based multi-cancer

screening products.
Also in January 2021, Exact Sciences acquired an exclusive license to The Translational
Genomics Research Institute’s proprietary Targeted Digital Sequencing technology for use
in minimal residual disease.
In February 2021, Exact Sciences announced that it has entered into an agreement to
acquire Ashion Analytics. The acquisition was finalized in April 2021.
In May 2021, the company acquired PFS Genomics and in April the company acquired
Ashion Analytics.
In September 2021, the company entered into an agreement to hire 400 former Pfizer sales
personnel to help increase the adoption of the Cologuard test.
In December 2021, the company acquired PreventionGenetics, and it also acquired an

exclusive license for the U.S. services of Xerna TME Panel (OncXerna Therapeutics).
COVID-19
In March 2020, responding to the emergent public health crisis, Exact Sciences began
providing COVID-19 testing. The company reported more than 2 million results had been
delivered for residents in all 50 states by the end of 2020.
Beginning in March 2020, the company also allocated space at its clinical laboratories in
Madison, Wisconsin to process the COVID-19 tests.
Exact Sciences reported COVID-19 testing revenues of nearly $143 million in 2021, a
decline from $236 million in 2020. Revenues are expected to decline further in 2022 due to
pandemic abatement and alternative testing options.

Hologic, Inc.
Bedford, MA
www.hologic.com
Table 4-16: Hologic Revenues 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Total Dx $1,197 $1,147 $1,180 $2,903 $3,516
Hologic diagnostic sales reached approximately $3,516 million in 2021. Diagnostic

revenues increased 20.5% compared to 2020 due to the increase in sales of COVID-19
assays.
Hologic’s diagnostics revenues are approximately 63.9% of the company’s total sales with
some 68% generated in the U.S.

The following is an estimate of the revenue stream of selected diagnostic segments ($

million):
Table 4-17: Global Hologic Revenues in Selected Test Segments 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Molecular $612 $675 $675 $2,452 $2,989
Blood Bank $140 $55 $58 $40 $47
ThinPrep/cytology $477 $480 $472 $411 $480
Hologic, Inc. is active in several markets: diagnostic products, medical imaging systems,
and surgical products. The company operates four core business units focused on
diagnostics, breast health, gynecological surgical and skeletal health.
Hologic’s diagnostics business is based primarily on molecular tests acquired with the
acquisition of Gen-Probe Inc. Hologic is best known for the ThinPrep Pap test and
ThinPrep Imaging system for cervical cancer screening with a liquid cervical fluid sample
and single layer slide preparation. The ThinPrep System is primarily used in cytology
applications, such as cervical cancer screening, and the Rapid Fetal Fibronectin Test assists
physicians in assessing the risk of pre-term birth. Rapid fFN (fetal fibronectin) test is a
marker to assess the risk of preterm birth.
In January 2021, Hologic acquired Biotheranostics, a leader in molecular tests for breast
and metastatic cancers.
In February 2021, Hologic and Google entered into a collaboration that features the
integration of Google Cloud’s machine learning with Hologic’s Genius Digital Diagnostics
System to achieve better screening and accelerate the eradication of cervical cancer.
In March 2021, Hologic acquired Diagenode, a molecular diagnostic company, to increase

Hologic’s molecular diagnostic business. Diagenode offers more than 30 real-time PCR
tests that are CE-marked for the detection of bacteria, parasites and viruses involved in
sexually transmitted infections, respiratory diseases, meningitis, and gastroenteritis.

Diagenode previously collaborated with Hologic to develop Panther Fusion assays for
group B Streptococcus and Bordetella.
In April 2021, Hologic announced that it is acquiring Mobidiag, an acute care POC
diagnostic testing company. Mobidiag develops and markets PCR-based tests for acute care
conditions such as gastrointestinal and respiratory infections, antimicrobial resistance
management, and healthcare associated infections. The Amplidiag and Novodiag platforms
are automated instruments that deliver rapid turnaround times ranging from 50 minutes to
two hours.
In June 2021, the company completed the acquisition of Mobidiag Oy, a molecular
diagnostic test company in Finland. The company is a developer of PCR-based test for
acute care conditions such as GI and respiratory infections, antimicrobial resistance
management and healthcare-associated infections.
PANTHER Molecular System
The Panther system was developed to complement the Tigris system that was designed for
high-volume clinical testing labs. Aptima is the brand name for Hologic’s line of
molecular assays. The Panther system was launched in Europe in late 2010 and is intended
for use in low- to mid-volume labs. Otherwise, the two platforms share many of the same
technologies, including a proprietary target capture method based on capture oligomers and
magnetic microparticles; and transcription-mediated amplification, an isothermal
amplification method that can produce billions of RNA amplicons from a single target
molecule in less than one hour.
The Panther system offers primary tube sampling with random access loading for
maximum flexibility and productivity. Multiple assays can be run from a single sample,
and operators have continuous access to samples, reagents and consumables. The system
has a small footprint and compact profile with a width of 48 inches, a depth of 32 inches,
and a height of 69 inches. The Panther system builds on Gen-Probe's Tigris system, which
was the first fully automated, high-throughput molecular testing system for large
laboratories. The Panther can also be used to test urine and genital samples for chlamydia
and gonorrhea.
The Panther system’s growing assay menu includes tests for chlamydia, gonorrhea,
trichomoniasis, HPV and HPV genotyping. In the U.S, the Panther menu includes tests for

HIV-1 viral load and sexually transmitted infections that include chlamydia, gonorrhea,
trichomonas, and human papillomavirus.
In February 2020, Hologic launched new product offerings for its Panther system within
the Panther Scalable Solutions portfolio including Panther Plus which add flexibility and
capacity to existing Panther systems, and Panther Link which is a software solution that
provides additional efficiencies by creating a virtual connection that allows multiple
Panther instruments to communicate with one another and function within a singular
workflow.
In December 2021, Hologic launched Panther Trax. The Panther Trax is the latest addition
to the Panther Scalable Solutions portfolio.
Panther Fusion
Hologic received FDA clearance to market its Panther Fusion Flu A/B/RSV assay running
on the Panther Fusion system.
Hologic received FDA clearance to market its Panther Fusion AdV/hMPV/RV assay. The
multiplexed detects Adenovirus, human Metapneumovirus, and Rhinovirus. It is the third
diagnostic assay available on the Panther Fusion system, complementing the Panther
Fusion Flu A/B/RSV assay and the Panther Fusion Paraflu assay, which both received
clearance in October 2017.
The next generation Panther Fusion is available as a full system, or the Panther Fusion
module can be attached to existing Panther systems in the field to extend testing
capabilities. The Panther Fusion module adds the capacity to run PCR assays in addition to
tests based on TMA (transcription-mediated amplification), the proprietary Hologic
chemistry that powers the company’s Aptima brand. The Panther Fusion system retains all
the key benefits of the Panther platform, including full sample-to-result automation, and is
suitable to any size laboratory.
The Panther Fusion assays offer a modular approach to syndromic respiratory testing via
the ability to run one, two or all three assays from a single patient specimen. to existing
Panther systems to extend testing capabilities. According to Hologic, the Panther side of
the instrument is designed for high volume tests that use liquid reagents. The Fusion side
uses a cartridge format that is conducive for low volume testing.

The company has been working on expanding the test menu for the Fusion system.
Hologic was awarded the CE Mark for its Panther Fusion Bordetella assay, expanding the
menu of the molecular testing device. The real-time PCR assay can detect and differentiate
between B. pertussis and B. parapertussis from samples collected from the patient’s
nasopharynx. Because the assay can differentiate between the two bacteria, which are
known to cause whooping cough, it enables physicians to prescribe the right antibiotic for
the patient.
Hologic announced the availability of Open Access functionality for its Panther Fusion
system that allows CLIA-certified laboratories to develop laboratory developed tests
(LDTs) to run on the fully automated Fusion platform. Laboratories are able to run their
LDTs simultaneously with commercially available IVD assays, and results are release
automatically to laboratory information systems. The Open Access functionality is enabled
by the new myAccess software, which is designed to help laboratories create protocols,
analyze data, set thresholds, and interpret results.
Laboratories can combine Women’s Health, Virology, Respiratory, Hospital-Acquired

Infections, and Open Access tests on the Panther Fusion system, running up to 32 different
assays at the same time. In addition, Panther Fusion offers labs the potential to process up
to 500 Panther Fusion and Aptima assays in an 8-hour period.
In May 2022, Hologic launched two molecular assays, Panther Fusion EBV Quant Assay
and Panther Fusion BKV Quant Assay. The assays are in vitro NATT test that are run on
the Panther Fusion system. Panther Fusion EBV Quant is used with whole blood and
plasma for management of transplant patients monitoring viral levels. The BKV Quant is
used with plasma and urine samples to identify important biomarkers when using
quantitative NAATs for diagnosis and management of transplant patients.
Infectious Diseases
Hologic received FDA clearance to market its Aptima HCV Quant Dx assay on the Panther
system, to quantify hepatitis C viral load and confirm active HCV infection. The assay
uses real-time transcription-mediated amplification to provide quantitation for
determination of sustained antiviral response across all major genotypes.
Hologic received FDA clearance to market the Aptima Herpes Simplex Virus 1 & 2
molecular assay on the Panther system. The test used in conjunction with swab specimens

from anogenital skin lesions, can be used to qualitatively detect and differentiate between
HSV-1 and HSV-2. Clinicians collect samples using a new Aptima Multitest Swab
Specimen Collection Kit or commercially available viral transport media.
Hologic received FDA clearance to market the Aptima HBV Quant Assay for quantitation
of hepatitis B viral load on the Panther system. The assay quantitates HBV DNA across
genotypes A-H. Thus, with the Panther system, labs can run viral load assays for HIV-1,
HCV, and HBV in parallel or from a single patient sample. The assay joins a previously
approved Aptima HIV-1 Quant Assay for human immunodeficiency virus and Aptima
HCV Quant Dx Assay for hepatitis C virus on the Panther system's viral load menu. All
three assays use real-time transcription-mediated amplification, which the firm said
provides highly sensitive and specific performance.
In June 2021, Hologic received CE Mark for Aptima CMV Quant assay in Europe. The
assay quantifies the viral load of CMV and is intended for use to aid in the diagnosis and
management of solid-organ transplant patients and hematopoietic stem cell transplant
patients.
In May 2022, Hologic received FDA approval of Aptima CMV Quant Assay to quantify
the viral load of CMV in transplant patients.
Sexually Transmitted Infections
In January 2019, Hologic received de novo FDA clearance to market the Aptima assay for
Mycoplasma genitalium sexually-transmitted infection in men and women. The FDA said
that this is the first test it has authorized to test for M. genitalium, a slow-growing
bacterium that is difficult to detect with traditional laboratory methods and is associated
with inflammation of the urethra in men and inflammation of the cervix and infection of the
reproductive organs in women.
Hologic's Aptima assay is a nucleic acid amplification test used for the qualitative detection
of M. genitalium rRNA on the automated Panther system. It detects M. genitalium in urine,
urethral, penile-meatal, endocervical, or vaginal swab samples collected in a clinical
setting.

Cytology
Hologic markets the market-leading ThinPrep liquid cytology franchise. Hologic reported
that the company is a leading supplier in Europe of Pap tests (ThinPrep) and HPV tests
(Aptima). These tests can be used on the same sample to screen for cervical pre-cancer and
cancer (independently or together for co-testing: Pap+HPV together).
The Genesis processor is the latest extension of the ThinPrep portfolio, which (according to
Hologic) revolutionized and increased the accuracy of cervical cancer screening with the
first liquid-based Pap test in 1996. Hologic launched an updated ThinPrep 2000 processor
in 2017 and received FDA approval in 2018 for the ThinPrep Integrated Imager, which
guides cytotechnologists to areas showing potential abnormal cells.
In conjunction with the ThinPrep Integrated Imager, Hologic is also launching the Compass
Stainer in the U.S. Already available internationally, the Compass Stainer is a smaller
footprint automated stainer that can perform both routine and special staining protocols.
Hologic reported that most ThinPrep Pap tests are currently run-in high-volume reference
laboratories that employ automated imaging via the Hologic ThinPrep Imaging System.
The ThinPrep Integrated Imager combines the power of ThinPrep computer-assisted
imaging and the ease of dual slide review into a single, automated microscope, bringing
increased sensitivity for cervical disease detection to laboratories of all sizes.
In April 2021, Hologic released its Genius Digital Diagnostics System, which is the next
generation cervical cancer screening product that combines AI with advanced imaging
technology to identify pre-cancerous lesions and cervical cancer cells. The system works in
conjunction with ThinPrep Pap test to create a single view.
COVID-19
In March 2020, the FDA granted Hologic EUA authorization for its new Panther Fusion
SARS-CoV-2 assay, a molecular test that detects SARS-CoV-2. The Panther Fusion SARS-
CoV-2 assay is a real-time RT-PCR in vitro diagnostic test intended for the qualitative
detection of RNA from the SARS-CoV-2 isolated and purified from nasopharyngeal and
oropharyngeal swab specimens obtained from individuals who meet COVID-19 clinical
and/or epidemiological criteria.

In May 2020, the company received FDA EUA authorization for its Aptima SARS-CoV-2
assays for the detection of SARS-Co-V-2 which is run on the standard Panther and Panther
Fusion systems.
In September 2020, Hologic was granted FDA EUA authorization for its asymptomatic
COVID-19 testing with Panther Fusion SARS-CoV-2 assay. Hologic’s assay is the first
widely available, high-throughput molecular diagnostic test specifically authorized for
screening asymptomatic people. This availability is expected to play a key role in
identifying early infection in exposed individuals, as well as reopening schools, workplaces
and the economy in general.
In December 2020, Hologic received FDA EUA authorization for its Aptima SARS-CoV-
2/Flu assay.
In January 2022, Hologic added the Aptima SARS-CoV-2 assay to its Global Access
Initiative.
“Hologic remains committed to building diagnostic capacity and equitable health systems
through affordable and accessible technical innovation,” said Joao Malagueira, Hologic’s
vice president, EMEA Commercial. “We have a responsibility to bridge the diagnostic gap
to sustainably control current and future disease outbreaks globally, and the expansion of
the GAI to include our Aptima SARS-CoV-2 assay empowers countries to respond to the
pandemic and control new waves of COVID-19.”
Hologic received CE marking for two new respiratory assays for the detection of COVID-
19, Flu A, Flu B and RSV for the Panther Fusion and the Novodiag Systems. Both assays
detect and differentiate the four listed respiratory viruses which produce similar symptoms.
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is fully automated. The Novodiag
RESP-4 assay runs on the Novodiag system and is also fully automated for infectious
disease testing.
“As we move into the next phase of COVID, it is important that we evolve our assays to
support our customers with tests that enable them to differentiate between the multiple
respiratory pathogens as easily as possible. The ability to accurately differentiate between
respiratory viruses with similar symptoms is essential if physicians are to ensure optimized
care for each patient,” said Jan Verstreken, Group President International. “Together,
these two assays further build our international offering of molecular diagnostic scalable

solutions that meet the growing needs of a broad range of customers, from single-patient
rapid testing to population-level screening.”

Illumina
San Diego, CA
www.illumina.com
Table 4-18: Illumina Revenue History ($ million – not all revenues are for clinical products and services;
estimated)
2017 2018 2019 2020 2021
Total Revenues $2,289 $2,749 $2,929 $3,239 $4,521
Illumina reported 2021 revenue of $4,521 million, an increase of 39.7% compared to

$3,239 million in 2020 primarily due to growth in sequencing consumables and
instruments.

Revenues are estimated as follows:
Table 4-19: Illumina Diagnostic Revenues by Segment ($ million) est
2017 2018 2019 2020 2021
Clinical Sequencing $1,971 $2,359 $2,592 $2,456 $3,650
Microarray $318 $390 $337 $279 $323
Other Revenue $463 $584 $614 $504 $546
Kalorama Information
In November 2018, Illumina announced that it planned to acquire Pacific Biosciences. The
acquisition complements Illumina sequencing solutions with accurate long-read sequencing
capabilities to answer a set of complex genomic questions in functional genomics, tissue
transplantation, and pharmacogenomics.
However, on April 17, 2019, GenomeWeb reported that the UK government's Competition
and Markets Authority (CMA) launched an investigation into Illumina's planned
acquisition of Pacific Biosciences. CMA is considering whether the acquisition "will result
in the creation of a relevant merger situation under the merger provisions of the Enterprise
Act 2002" and whether it will likely result "in a substantial lessening of competition within
any market or markets in the United Kingdom for goods or services." Until May 3,
stakeholders are invited to send the agency comments on competition issues with a deadline
of May 3, 2019.
In January 2020, Illumina and Pacific Biosciences announced the termination of the merger
agreement.
The heart of its business, Illumina’s sequencers offer a broad range of genomic
applications, including whole-genome sequencing, targeted resequencing, de novo
sequencing, amplicon sequencing, SNP discovery, identification of copy number variations,
and chromosomal rearrangement. The company’s sequencing products have been
developed to meet the growing demand for next generation sequencing and to compete
primarily with Thermo Fisher Scientific’s Life Technologies’ Ion Torrent systems.

Illumina’s MiSeq is a low-cost personal sequencing system that provides individual

researchers a platform with rapid turnaround time, unmatched accuracy, and radically
improved ease of use. Leveraging the company’s TruSeq sequencing chemistry, the
system’s workflow offers the flexibility to go from purified DNA to analyzed data in as few
as eight hours, or to generate in excess of 1 gigabase per run in slightly over a day.
The MiSeqDx Sequencing System is a benchtop sequencer that incorporates an easy-to-use

workflow and data output tailored to the diverse needs of clinical labs. Based on Illumina
sequencing by synthesis (SBS) chemistry, the MiSeqDx Sequencing System provides IVD
developers the tools to create accurate diagnostic testing. Additionally, integrated software
enables run setup, sample tracking, user management, audit trails and data interpretation.
The MiSeqDx Sequencing System has regulatory approval in the United States, China,
Canada, Argentina, and European countries recognizing the CE-IVD mark, Australia, South
Korea, Singapore, Thailand and the Philippines.
With Amgen, Illumina developed a companion diagnostic test kit that interrogates 56
variants across the KRAS and NRAS genes in order to establish mutant status in a single
test. Illumina stated: “The Extended RAS Panel on the MiSeqDx System enables labs to
implement an in-house solution for precision oncology and signifies that NGS has reached
a milestone as a clinical diagnostic platform to aid therapeutic decision-making in
oncology.”
Illumina and Bio-Rad Laboratories launched the Illumina Bio-Rad Single-Cell Sequencing
Solution that the companies stated is the first next-generation sequencing (NGS) workflow
for single-cell analysis, providing researchers the ability to investigate the coordinated
contribution of individual cells in tissue function, disease progression, and therapeutic
response.
The solution comprises the ddSEQ Single-Cell Isolator and SureCell WTA 3’ Library Prep
Kit. Bio-Rad’s Droplet Digital technology is used to isolate and barcode single cells for
downstream sequencing on many of Illumina’s leading NGS instruments. Primary and
secondary data analysis is conducted via the BaseSpace Informatics Suite, Illumina’s cloud-
based genomics computing environment, and tertiary data analysis and visualization with
SeqGeq from FlowJo, LLC, a leader in flow cytometry analysis.
Illumina launched the iSeq 100 Sequencing System, a new next-generation sequencing
(NGS) system that delivers (according to Illumina) exceptional data accuracy, at a low

capital cost, making Illumina technology available to virtually any lab. The combination of
the company’s sequencing by synthesis (SBS) chemistry, along with the complementary
metal-oxide-semiconductor (CMOS) detection technology, represents an entirely different
configuration that delivers highly accurate data at substantially lower capital costs
(according to Illumina).
Illumina launched TruSight Oncology 500 (TSO 500), a comprehensive pan-cancer assay
designed to identify known and emerging tumor biomarkers. TruSight Oncology 500
utilizes both DNA and RNA from subject tumor samples to identify key somatic variants
underlying tumor progression, such as small DNA variants, fusions, and splice variants.
Importantly, TruSight Oncology 500 can measure tumor mutational burden (TMB) and
microsatellite instability (MSI), features that are potentially key biomarkers for emerging
immunotherapies.
In January 2019, Illumina launched a new chip for its NovaSeq instrument and upgrades to
the iSeq sequencer in the first quarter of 2019. The planned SP chip for the NovaSeq will
have the "fastest run time, lowest run cost, and longest reads.”
In May 2022, Illumina introduced Pan-Cancer companion diagnostic to its TruSight

Oncology Comprehensive test. The test assesses multiple tumor genes and biomarkers to
reveal the specific molecular profile of the patient’s cancer. The CDx pan-cancer indication
allows identification of cancer patients with solid tumors that are positive for NTRK gene
fusions including NTRK1, NTRK2 or NTRK3 and could benefit from Bayer’s Vitrakvi.
CareDx signed a licensing and commercialization agreement with Illumina for the
worldwide distribution, development, and commercialization rights to Illumina's next-
generation sequencing transplant clinical application products.
CareDx will be the exclusive worldwide distributor of Illumina's TruSight HLA v1 and v2
product lines, and associated Assign HLA software. CareDx plans to use the Illumina
products for bone marrow transplantation diagnostic testing and solid organ transplantation
diagnostic testing. It has also been granted exclusive rights to develop and commercialize
the next generation, v3, of the HLA product lines for use in bone marrow and solid organ
transplant testing, and as an NGS product for chimerism detection.
CareDx will use its own trademarks for commercialization of the development stage HLA
and chimerism products and intends to use names under the overall brand of AlloSeq. The
individual products will be named AlloSeq HLA, AlloSeq BMT, and AlloSeq cfDNA.

Further, CareDx has made a $5 million initial payment to Illumina and will pay royalties in
the mid-single to low-double digits on sales of future commercialized products. The firm
has also agreed to minimum purchase commitments of finished products and raw materials
from Illumina through 2023. Illumina, in turn, has agreed to provide transition and support
services to CareDx.
Illumina announced the establishment of GRAIL Bio as a separate company, majority

owned by Illumina. The company was formed to enable cancer screening from a simple
blood test. Powered by Illumina sequencing technology, GRAIL will develop a pan-cancer
screening test by directly measuring circulating nucleic acids in blood.
Illumina launched TruSight Oncology 500 (TSO 500), a comprehensive pan-cancer assay
then in February 2019, Illumina formed a partnership with the U.S. National Cancer
Institute to validate the sequencing assay for an eventual liquid biopsy application.
Illumina reported that the U.S. Frederick National Laboratory for Cancer Research has
selected TSO 500 for several National Cancer Institute-sponsored clinical studies. As part
of a five-year collaboration, the assay will be used on liquid biopsies to assess up to 7,000
patient samples, including one study that will investigate concordance between circulating
tumor DNA and matched tissue.
TSO 500 would put Illumina in direct competition with a number of its customers,
including Foundation Medicine and Guardant Health, both of which have also developed
liquid biopsy assays that analyze tumor mutational burden. Foundation Medicine, a unit of
Roche Diagnostics, is also looking to develop a blood-based version of its tumor mutational
burden assay as a companion diagnostic for the immunotherapy drug Tecentriq
(atezolizumab).
However, June 2018, Foundation Medicine and Illumina amended their supply and service
agreement and extended the terms of the agreement through June 6, 2023, according to a
document filed with the U.S. Securities and Exchange Commission by Foundation
Medicine.
According to the agreement, Illumina will supply Foundation Medicine and its German
subsidiary with sequencers, reagents, other consumables, as well as service contracts to
maintain and repair its instruments. Foundation Medicine has committed to purchasing a
certain number of reagents and other consumables every six months. Sequencers and

service contract prices will be based on Illumina's list prices, while reagents and
consumables prices are fixed for a set period of time.
In June 2019, Illumina launched VeriSeq NIPT solution v2 a CE marked NGS solution.
The automated comprehensive solution allows laboratories to screen for a broader range of
chromosomal and sub-chromosomal conditions associated with birth defects and adverse
pregnancy outcomes than the standard NIPT menu. VeriSeq NIPT Solution v2 delivers the
most comprehensive view of the fetal genome compared to other CE-IVD NIPT products,
enabling healthcare providers to support expectant parents with informed, timely and
personalized pregnancy management options better than ever before. VeriSeq NIPT
Solution v2 is now available across most countries in Europe, as well as South Africa.
Product registration is pending in Australia, Israel and New Zealand.
TruSight Tumor 170 is a next-generation sequencing test that interrogates point mutations,
fusions, amplifications and splice variants in 170 genes associated with common solid
tumors. The CDx version of TruSight Tumor 170 will allow local laboratories to provide
referring physicians with comprehensive genomic information, so that patients can be
matched to the most appropriate therapeutic options. This version of TruSight Tumor 170
will run on the NextSeq 550Dx platform.
In January 2019, Illumina and PierianDx signed a non-exclusive, multi-year partnership to

develop cancer sequencing products. PierianDx will provide variant interpretation and
reporting, based on its Clinical Genomics Workspace platform and Clinical Genomics
Knowledgebase, for Illumina's TruSight Tumor 170 and TruSight Oncology 500 research
assays, as well as for future in vitro diagnostic products.
Illumina will be responsible for distributing the oncology products and packaged solutions.
Labs that purchase the oncology assays with PierianDx informatics will have access to the
PierianDx Clinical Genomics Workspace for analysis, interpretation, and reporting of
results and will be able to get additional services from PierianDx, such as medical sign-out
and electronic medical record integration.
In October 2019, Illumina entered into a partnership with QIAGEN to broaden the
availability and use of NGS-based IVD kits, including companion diagnostics. The
agreement grants QIAGEN non-exclusive rights to develop and globally commercialize
IVD kits to be used together with Illumina’s MiSeq Dx and NextSeq 550Dx Systems. The
agreement also includes rights for expansion of the partnership on future Illumina

diagnostic systems. Both partners are also exploring opportunities for QIAGEN to develop
and market companion diagnostics based on Illumina’s TruSight Oncology (TSO) assays
that enable comprehensive genomic profiling of tumor samples in immunotherapy.
In January 2020, Illumina and Roche entered into a partnership to broaden the adoption of
distributable NGS testing in oncology. As part of this agreement, Illumina will grant Roche
rights to develop and distribute in-vitro diagnostic (IVD) tests on Illumina’s NextSeq
550Dx System, as well as on its future portfolio of diagnostic (Dx) sequencing systems,
including the forthcoming NovaSeqDx. Roche will in turn collaborate with Illumina to
complement Illumina’s comprehensive pan-cancer assay, TruSight Oncology 500 (TSO
500), with new companion diagnostic (CDx) claims. The financial terms of the deal were
not disclosed.
In January 2020, Illumina and Pacific Biosciences mutually agreed to terminate their
merger agreement which began in November 2018.
In June 2020, Illumina acquired BlueBee to accelerate processing, analysis and sharing of
NGS data at scale.
In September 2020, Illumina announced that it had entered into an agreement to acquire
GRAIL. GRAIL offers the Galleri multi-cancer screening test.
In January 2021, Illumina entered into several new and expanded partnerships with BMS,
Kura Oncology, Myriad Genetics, and Merck to develop standardized tools for precision
oncology.
In April 2021, Illumina entered into a partnership with Kartos Therapeutics to co-develop a
TP53 CDx based on the content of Illumina’s TruSight Oncology 500. The CDx is for
multiple hematologic indications, and it will be the first to use TSO 500 with peripheral
whole blood.
In August 2021, Illumina acquired GRAIL and GRAIL’s Galleri blood test that detects
various types of cancers before they are symptomatic. The acquisition will accelerate the
adoption of NGS-based early multi-cancer detection tests.

COVID-19
Illumina received FDA EUA authorization for its sequencing-based COVID-19 diagnostic
test. The COVIDSeq uses upper respiratory specimens, including a nasopharyngeal or
oropharyngeal swab, and delivers sample receipt to result in 24 hours using the NovaSeq
6000 Sequencing System. The differentiated diagnostic design includes 98 amplicons that
target the full SARS-CoV-2 genome, creating accurate detection and high sensitivity.
COVIDSeq is currently available to a limited number of early access sites and is expected
to be more broadly available summer 2020.
In January 2021, Illumina and Helix entered into a collaboration to assess the prevalence of
the SARS-CoV-2 UK Variant in the U.S. The combination of Illumina’s sequencing
technology and expertise and Helix’s national COVID-19 testing footprint will
significantly expand the country’s existing surveillance efforts to detect and characterize
emerging variants of SARS-CoV-2.

Ortho Clinical Diagnostics (QuidelOrtho)
Raritan, NJ
www.jnj.co
Table 4-20: Ortho Clinical Diagnostics Revenues 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Total $1,700 $1,727 $1,740 $1,735 $2,011
In May 2022, Quidel completed the acquisition of Ortho Clinical Diagnostics. The new
company, called QuidelOrtho, is headquartered in San Diego, California.
Geographically, some 61% of Ortho Clinical Diagnostic's sales were generated in North
America and the rest internationally.
Clinical laboratories accounted for $1,363 million in 2021, increasing by $20.2 million over
2020. This was mainly due to increased sales in North America and COVID-19 sales.

The following is Kalorama’s estimate of the breakdown of OCD's revenue in selected test
segments in 2021.
Table 4-21: Global Ortho Clinical Diagnostics Revenues in Selected Test Segments 2021 (millions $)
Item/Year 2021
Immunoassays $850
Chemistry $513
Blood Grouping $658
Ortho-Clinical Diagnostics produces in-vitro diagnostics equipment and associated assays

and reagents. Ortho's largest segment, Clinical Laboratories, develops clinical chemistry
and immunoassay tests, targeting primarily small/medium size hospitals. Ortho also
develops immunohematology products used by blood banks and hospitals to determine

patient-donor compatibility in blood transfusions. Ortho also develops and markets

equipment and assays for blood and plasma screening for infectious diseases.
Ortho was selected for a gold-level Edison Award in the Best New Product Awards
category for its VITROS NEPHROCHECK Test. VITROS NEPHROCHECK (according
to Ortho) is the first fully automated risk assessment tool for predicting acute kidney injury
(AKI), a serious and potentially fatal condition affecting hospital patients worldwide.
The VITROS NEPHROCHECK Test detects two key urinary biomarkers, TIMP-2 and
IGFBP-7, first discovered by Astute Medical, which indicate risk of AKI in intensive care
unit patients. It is a simple urine test that provides lab results in 16 minutes. Ortho
developed VITROS NEPHROCHECK and launched it in CE Mark countries in 2017.
Edison Award winners are selected as the "best of the best" by 3,000 of the world's top
senior business executives, academics and innovation professionals.
Ortho announced that, for the third year in a row, the Ortho Care service and support
program was the highest-ranked original equipment manufacturer for overall service
performance in the diagnostics industry. The rankings were published in three IMV 2018
ServiceTrak reports, which are based on opinions of laboratory professionals working in
U.S. hospitals representing more than 3,000 systems. Respondents were randomly
distributed across the U.S., both geographically and by hospital size.
Blood Bank
For more than 75 years, Ortho has pioneered advances in immunohematology, from early
work in blood typing to the latest developments in laboratory systems. Ortho serves the
global transfusion medicine community with donor screening and blood typing products to
help ensure every patient receives blood that is safe, the right type and the right unit.
Ortho Clinical Diagnostics is committed to blood safety. More than 20 years ago, the
company introduced the first test for the detection of antibodies to hepatitis C and has since
remained a leader in the marketing and development of instrumentation and reagent
systems for blood typing. Further automation of rare phenotyping using Ortho’s
instrumentation is expected in the future.
Ortho announced that ORTHO Sera, a fully automated solution for extended antigen
phenotyping was awarded the CE Mark and is available on the ORTHO VISION Analyzer.
ORTHO Sera expands the testing menu on the ORTHO VISION, allowing virtually all

testing to be done on one platform and delivering results in a maximum of 20 minutes.

The product received FDA clearance in August 2017 for use with Ortho’s ID-Micro Typing
System Gel Card technology.
ORTHO Sera extended phenotype tests cover more than 99% of the most commonly tested
blood group antigens, providing support for patients with unexpected antibodies. ORTHO
Sera has been developed to use ORTHO BioVue System Column Agglutination
Technology, eliminating the need to purchase additional cassettes.
ORTHO Sera enables customized, flexible profile testing through an antisera additive
approach. This allows extended phenotyping to be personalized according to patient needs.
The 13 ORTHO Sera reagents available on the ORTHO VISION Analyzer platform include
Anti-Fya, Anti-Fyb, Anti-Jka, Anti-Jkb, Anti-S, Anti-s, Anti-K, Anti-D (IAT), Anti-D
(DVI), Anti-P1, Anti-Lea, Anti-Leb and Anti-M. ORTHO Sera manual testing was
previously available on ORTHO Workstation.
Ortho received FDA clearance to market the ORTHO Sera blood grouping reagents that are
designed for extended phenotype testing. According to Ortho, the company was the only
provider in the U.S. that offers a comprehensive menu of antisera for extended antigen
phenotyping in a gel testing format.
Ortho received FDA clearance to market its ORTHO CONNECT V2.0 middleware
solution. ORTHO CONNECT is a comprehensive, integrated and customizable
middleware system that centralizes laboratory operations and workflow across hospitals
and networks, allowing blood banks and their data to be confidently managed through one
central terminal. It also enables the ORTHO VISION and ORTHO VISION Max
immunohematology analyzers, which test blood for transfusion compatibility, to integrate
with a hospital’s laboratory information systems (LIS) through a single validated
connection to exchange data and simplify processes.
In transfusion medicine, Ortho, in collaboration with Novartis Diagnostics, had marketed

blood virus ELISA screening tests for hepatitis B and C, HIV to blood banks. In 2013,
Novartis sold its blood bank business to Grifols (Barcelona, Spain). In July 2016, Grifols
extended the arrangement with Ortho Clinical Diagnostics until 2026.
Ortho demonstrated how its ORTHO CONNECT V2.0 middleware system is part of its
portfolio of solutions for the ORTHO CONNECT and the automated ORTHO VISION and
VISION Max immunohematology analyzers.

In October 2019, FDA cleared Ortho’s Sera ID-MTS for use on the Ortho Vision Analyzer
In September 2021, Ortho launched the new ISXM (Immediate Spin Crossmatch) for the
company’s ORTHO VISION and ORTHO VISION MAX Analyzers to detect
incompatibility between donors and recipients in blood transfusions. ISMX is a serological
tests.
Core Lab / Immunoassays
The Ortho VITROS Chemistry, Immunodiagnostics and Integrated Systems represent a

portfolio of products for coagulation, clinical chemistry and immunoassays. Ortho's
VITROS brand chemistry and immunoassay analyzers offer a broad menu covering basic
metabolites, classical chemistries, special chemistries, proteins, toxicology and therapeutic
drug monitoring tests. Ortho's enhanced chemiluminescence technology and immunoassay
systems offer tests for thyroid function, reproductive endocrinology, cardiology, anemia,
metabolism, oncology and infectious diseases.
In oncology immunoassays, Ortho's VITROS ECi Immunodiagnostic System offers tests

for CA 125, CEA, alpha-fetoprotein and CA 15-3. Ortho has engaged in a number of
alliances with a view to expanding its presence in the cancer test market.
In April 2019, Ortho in collaboration with Diazyme Laboratories, Inc. (Poway, CA) has
launched its D-Dimer assay, the latest offering in Ortho’s MicroTip Partnership Assay
program that was launched in 2016. The D-Dimer assay detects the presence of
intravascular coagulation and fibrinolysis through the measurement of the fibrin
degradation product D-Dimer in venous thromboembolism (blood clots).
In February 2020, Ortho launched the VITROS XT 3400 Chemistry System. The new
VITROS XT 3400 Chemistry System simultaneously performs two tests frequently ordered
together on one VITROS XT MicroSlide, a multi-layered, postage-stamp sized slide which
filters out lipids and proteins that can impact the quality of results and offers an up-to-40
percent higher throughput than current slides.
In March 2020, the company’s B.R.A.H.M.S. PCT Assay was granted FDA clearance to
assist physicians to identify sepsis and other severe bacterial infections.

COVID-19
In April 2020, Ortho launched its SARS-CoV-2 antibody test, the VITROS
Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack. The test runs on the
VITROS XT 7600 Integrated System, the VITROS 3600 Immunodiagnostic System, the
VITROS 5600 Integrated System and VITROS ECi/ECiQ Immunodiagnostic Systems and
can process approximately 150 tests in an hour. Additionally, in April 2020, Ortho
launched its second COVID-19 antibody test, the IgG test. Both antibody tests for COVID-
19 received CE Mark in May 2020
In May 2020, Ortho entered into a partnership with Quest Diagnostics to expand COVID-
19 antibody testing to 20 Quest labs. Quest uses Ortho’s VITROS Immunodiagnostic
Products Anti-SARS-CoV-2 IgG Test (COVID-19 IgG antibody test) to test patients for
detectable levels of SARS-CoV-2 antibodies, which are generated by the body in response
to infection.
In January 2021, Ortho received FDA EUA authorization for it VITROS SARS-CoV-2,
which is the first high-volume COVID-19 antigen test granted EUA. The test is run on
Ortho’s high-volume VITROS systems.
In July 2021, the company received FDA EUA for its quantitative COVID-19 IgG
Antibody Test.
In August 2021, Ortho Clinical received FDA EUA for its qualitative VITROS ANTI-
SARS COVID-19 N antibody test. The test is the fifth assay to received EUA within
Ortho’s COVID-19 testing portfolio.

QIAGEN N.V.
Venlo, Netherlands
www.QIAGEN.com
Table 4-22: QIAGEN N.V. IVD Revenues 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Total Diagnostics IVD $683 $732 $737 $904 $1,143
QIAGEN reports IVD sales grew 26.4% to $1,143 million in 2021 compared to $904
million in 2020. There was significant demand for solutions used in the COVID-19
pandemic. Molecular diagnostics accounted for $1.1 billion in sales in 2021.
QIAGEN has built an increasing presence in key emerging markets as a growth strategy. In
2021, the top seven emerging markets - Brazil, Russia, India, China, South Korea, Mexico
and Turkey - contributed approximately $309 million in sales.

Figure 4-12: 2021 QIAGEN IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
The following is an estimate of QIAGEN’s molecular IVD product revenues ($ million

estimated):
Table 4-23: Global QIAGEN IVD Revenues by Type, 2017-2021 (million)
Item/Year 2017 2018 2019 2020 2021
TB & Respiratory $175 $223 $240 $257 $505
Other Molecular $365 $354 $302 $439 $352
NGen Sequencing $115 $140 $y718 $166 $245
HPV $28 $15 $15 $42 $41
QIAGEN N.V. is a holding company with subsidiaries in Germany, the United States,
China, Japan, the United Kingdom, Switzerland, France, Italy, Australia, Norway, Austria,
Canada, Sweden, and the Netherlands.

QIAGEN markets more than 500 products around the world, selling both consumable kits
and automation systems to organizations within molecular diagnostics, applied testing,
pharmaceuticals, biotechnology, and academia. QIAGEN pioneered DNA and RNA
extraction for molecular test sample preparation. For the past few years, QIAGEN has
transformed itself into a molecular diagnostics company with previous acquisition of DxS,
Eppendorf’s DNA reagent business, artus, eGENE, Genaco, Biotage, Corbett Life Science
and Digene. Now QIAGEN’s clinical business is focusing on market and product
expansion and is moving from a base in infectious diseases to cancer testing and
personalized medicine.
In addition to tuberculosis testing, QIAGEN continues to expand its immune-monitoring

pipeline for the future, developing new applications and content for QuantiFERON
technology and other emerging platforms.
QIAGEN, a global pioneer in Personalized Healthcare, markets a portfolio of more than 30

companion diagnostics, which detect genetic abnormalities to provide insights that guide
clinical decision-making. QIAGEN continues to expand its pipeline of solutions for
precision medicine in cancer and other diseases, partnering with more than 25
pharmaceutical and biotechnology companies to co-develop companion and
complementary diagnostics.
The company’s test solutions span disease stages including screening, diagnostic,
prognostic, predictive, and therapeutic and recurrence monitoring. QIAGEN’s pipeline
draws on a full range of testing platforms including polymerase chain reaction (PCR) using
QIAsymphony workflows, next-generation sequencing (NGS) with the GeneReader NGS
System and universal solutions, and near-patient testing with QIAstat-Dx.
QIAGEN is a global leader in Sample to Insight solutions, with a portfolio of technologies

to empower customers from start to finish in the molecular testing process. QIAGEN
provides tissue and liquid biopsy-based tests for personalized healthcare using companion
diagnostics to guide the use of medicines for treatment of cancer and other diseases.
In September 2020, QIAGEN acquired NeuMoDx.
In February 2021, QIAGEN entered into five initial partnerships with:

• DNAnexus
• GNS Healthcare
• Personal Genome Diagnostics
• ThermoFisher Scientific
• Wellcome Sanger Institute

Additionally, in February 2021, QIAGEN entered into an expanded collaboration with
Inovio to develop MGS companion diagnostic for Inovio’s VGX-3100 for advanced
cervical dysplasia.
Tuberculosis
According to QIAGEN its QuantiFERON-TB tests play an increasingly central role in the
global fight against tuberculosis (TB). Sales of the QuantiFERON-TB franchise, including
the fourth-generation QuantiFERON-TB Gold Plus (QFT-Plus) and third-generation
QuantiFERON-TB Gold (QFT) grew 8% in 2019 to $240 million.
The fourth-generation test adds clinical insights by measuring cell-mediated immune

response to TB infection from both CD4+ and CD8+ T cells, a feature cited by experts for
its potential to identify adults at greater risk of progressing to active TB. QIAGEN
continues to enhance the ease of use, efficiency and accessibility of QuantiFERON-TB
tests.
In January 2019, QIAGEN is partnering with Ellume (Brisbane, Australia), a digital

diagnostics developer of handheld phone enabled devices. The companies are developing
QuantiFERON-TB Access (QFT Access) as a latent tuberculosis workflow dedicated to the
needs of low-resource regions with a high disease burden of TB. Clinical trials for QFT
Access are planned for this year, and commercialization is began in 2020. Ellume is
receiving an AUS$21 million ($15 million) investment from QIAGEN as part of the
agreement.
QFT-Plus is the fourth generation of QIAGEN’s QuantiFERON-TB technology, combining

CD4+/CD8+ design for comprehensive immune response detection for screening in large-
scale TB control programs. QFT-Plus builds on the foundation of QuantiFERON-TB Gold
(QFT), the third generation of QIAGEN’s interferon gamma release assay (IGRA).

In April 2019, QIAGEN announced that its gold standard QuantiFERON-TB test for
detection of latent tuberculosis (TB) infections has surpassed 60 million tests administered.
QIAGEN reported that it is continuing to improve and innovate with new automation
options for the fourth-generation QuantiFERON-TB Gold Plus (QFT-Plus) test which
continues to drive rapid growth in the conversion of latent TB testing from the century-old
technology of tuberculin skin tests to QIAGEN’s modern, accurate and efficient blood test.
QIAGEN is partnering with two leaders in liquid handling solutions to provide options for
automated aliquoting of samples from the single tube option to the QuantiFERON-TB Gold
Plus Tubes for analysis with the QFT-Plus assay, for those customers who choose to
implement a single tube collection process. The collaborations integrate the Hamilton
Robotics Microlab STAR automated liquid handling workstation into the QFT-Plus assay
workflow, or the Tecan Fluent Laboratory Automation workstation to automate the manual
step of aliquoting of samples from a single collection device such as Lithium Heparin blood
collection tube into the QuantiFERON-TB Gold Plus workflow.
In November 2019, QIAGEN and DiaSorin launched an automated workflow for

QuantiFERON-TB Plus. The fourth-generation gold standard for latent TB detection. The
FDA approved the LIAISON QuantiFERON-TB Plus Test, developed by QIAGEN and
DiaSorin to offer streamlined laboratory automation for latent TB screening, supporting the
conversion from tuberculin skin tests to modern blood-based QuantiFERON technology.
The highly automated workflow on LIAISON platforms provides QuantiFERON customers
a powerful, highly flexible automation option for all throughput ranges.
In February 2020, QIAGEN’s QuantiFERON-TB Gold Plus was adopted for latent TB
testing in Nigeria.
In November 2021, QIAGEN and DiaSorin received approval of the LIAISON

QuantiFERON TB Gold Plus assay for use on DiaSorin’s automated LIAISON XS
platform.
QIAGEN launched a new tuberculosis blood test, the QIAreach QuantiFERON-TB test for
TB infection. The new test is a portable device that provides digital detection of TB
infection with end-to-end workflow and increases access to Interferon Gamma Release
Assay (IGRA) testing. QuantiFERON-TB uses blood samples to test for IGRA released
from T-cells that have come into contact with TB bacteria. The test is easy to administer
and provides results in 20 minutes.

Lyme Disease
In April 2021, the company, in partnership with DiaSorin, announced the launch of the new
LIAISON LymeDetect Assay based on QuantiFERON technology for early diagnosis of
Lyme Borreliosis.
Molecular Expansion
QIAGEN has reported that the company’s molecular portfolio of QIAsymphony, QIAstat-
Dx, GeneReader, and NeuMoDx enables QIAGEN to offer complementary systems that
create an “unparalleled portfolio of platforms for molecular diagnostics labs worldwide.
QIAGEN received FDA clearance to market for its QIAstat-Dx syndromic testing system
and respiratory assay panel for detection of multiple respiratory viral and bacterial
pathogens. The panel provides simultaneous testing for more than 20 pathogens.
Syndromic testing with molecular diagnostics can identify illnesses that manifest as a set of
symptoms with uncertain causes, such as influenza or pneumonia. QIAGEN said it expects
to release numerous diagnostics for infectious diseases, oncology and other areas.
QIAGEN and LabCorp launched a collaboration to provide Day-One access for patients to
companion diagnostics at the time of drug approvals. As a participant in QIAGEN’s Day-
One Lab Readiness program, LabCorp is able to provide physicians and patients with faster
access to tests for new, genomically targeted drugs that are becoming increasingly
important therapies for a growing variety of cancers. LabCorp is the latest company to join
the program, and its expertise in the commercial use of companion diagnostics help a
broader range of patients gain access to innovative tools for precision medicine. LabCorp
Diagnostics and the company’s Covance Drug Development business already work with
QIAGEN and its pharma partners on multiple oncology biomarker and clinical trial
programs.
In September 2020, QIAGEN finalized the acquisition of NeuMoDx Molecular.
In May 2022, the company launched its QIAstat-Dx Rise which is a high capacity version
of the original QIAstat-Dx syndromic system. The QIAstat-Dx Rise features a capacity of
up to 18 different tests and it can provide results for up to 56 tests in an eight-hour period.

Additionally, in May 2022, the company added HSV1/2 Quant Assay for the quantification
and differentiation of herpes simplex virus type 1 DNA and herpes simplex virus type 2.
Precision Medicine / Companion Diagnostics
QIAGEN is a pioneer in Precision Medicine and is a global leader in collaborations with

pharmaceutical and biotechnology companies. The company has more than 25 projects to
co-develop and market companion diagnostics with pharmaceutical and biotech companies
such as Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Clovis Oncology, Eli Lilly and
Company, and Pfizer.
In January 2019, QIAGEN announced that its Therascreen EGFR RGQ PCR kit has been
approved by the Japanese Pharmaceuticals and Medical Device Agency as a companion
diagnostic with Pfizer's Vizimpro (dacomitinib) for EGFR mutation-positive, inoperable, or
recurrent non-small cell lung cancer. The test uses real-time PCR on the Rotor-Gene Q
platform, a module in QIAGEN's QIAsymphony family of instruments. The kit is
registered in more than 40 countries, and it is QIAGEN's first companion diagnostic
approval in Japan.
In April 2019, QIAGEN announced the U.S. launch of its therascreen FGFR RGQ RT-PCR
Kit (therascreen FGFR Kit) as a companion diagnostic to help guide the use of the newly
approved FGFR kinase inhibitor, BALVERSA (erdafitinib), developed by Janssen Biotech,
Inc. (Janssen). The test aids in identifying patients with urothelial cancer (bladder cancer)
whose tumors have certain alterations in the fibroblast growth factor receptor 3 (FGFR3)
gene. The FDA co-approved the new test with BALVERSA, as announced by Janssen.
According to QIAGEN Balversa is the first targeted treatment that the FDA has approved
for bladder cancer patients with FGFR alterations. The therascreen FGFR Kit co-approval
with BALVERSA marks the sixth FDA approval of a therapy with a QIAGEN companion
diagnostic assay.
In May 2019, QIAGEN and Inovio Pharmaceuticals (Plymouth Meeting, PA) are
collaborating to develop a companion diagnostic to guide clinical decision making related
to Inovio's DNA-based immunotherapy for cervical dysplasia caused by human
papillomavirus. Inovio's VGX-3100 is a late-stage investigational product candidate with
potential to become the first treatment for HPV infection of the cervix and the first non-
surgical treatment for precancerous cervical lesions associated with the virus. Specifically,

the test is under investigation for treatment of infection with HPV 16 and HPV 18 and
precancerous lesions of the cervix (Phase 3), and the vulva and anus (Phase 2).
"Our team has deep experience in HPV-related molecular testing and cervical cancer and
is looking forward to applying this expertise in partnership with Inovio," QIAGEN CEO
Peer Schatz said in a statement. "This project is also a case study of a collaboration that
started in the discovery phase, when Inovio selected QIAGEN Genomic Services to work on
the discovery of novel biomarkers that now contribute to the power of this unique
molecular assay."
In May 2019, LabCorp began to sell QIAGEN's new companion diagnostic for bladder
cancer, the therascreen fibroblast growth factor receptor (FGFR) mutation analysis. The
test is designed to assess whether patients with urothelial cancer are eligible for treatment
with Johnson & Johnson's newly approved FGFR kinase inhibitor Balversa (erdafitinib).
The therascreen FGFR Kit runs on QIAGEN’s Rotor-Gene Q MDx, which leverages a
worldwide exclusive license for in vitro diagnostic use of FGFR3:TACC3 fusions from
Columbia University. The therascreen FGFR Kit is available through QIAGEN’s Day-One
Lab Readiness program to accelerate the availability of innovations in Precision Medicine.
That program is designed to speed patient access to companion diagnostics soon after FDA
has approved a new treatment and its associated test.
In May 2019, QIAGEN launched its FDA-approved companion diagnostic for PIK33CA
biomarkers to enhance precision medicine in breast cancer.
In April 2020, the company launched therascreen BRAF test as a companion diagnostic to a
BRAFTOVI based regimen in metastatic colorectal cancer.
In November 2020, QIAGEN entered into a collaboration with BioNTech for the
development of a companion diagnostic for HPV-associated squamous cell carcinoma of
the head and neck.
In February 2021, QIAGEN and Inovio expanded their collaboration to develop next
generation sequencing companion diagnostic for Inovio’s VGX-3100 for advanced cervical
dysplasia.

In May 2021, QIAGEN partnered with Mirati Therapeutics to develop KRAS-G12C CDx
for NSCLC. Additionally, in May, QIAGEN launched the first FDA-approved tissue CDx
to identify the KRAS G12C Mutation in NSCLC and other lung cancer options.
In July 2021, QIAGEN forged an alliance with Sysmex for the development of CDx using
NGS and plasma-safe-seqS technology.
In August 2021, the company and OncXerna Therapeutics entered into an agreement to
collaborate to advance the Xerna TME panel for regulatory approval as a NGS companion
diagnostic for Navicixizumab for ovarian cancer.
In May 2022, QIAGEN launched therascreen EGFR Plus RGQ PCR Kit. The test is
capable of detecting all currently known activating and resistance EGFR mutations
featuring C707S detection to help guide NSCLC treatment. This key biomarker indicates
resistance to third-generation EGFR tyrosine kinase inhibitor [TKI], giving oncologists
additional insights to adjust EGFR treatment for NSCLC patients.
“The therascreen EGFR Plus RGQ PCR Kit combines sensitivity in mutation detection with
the flexibility to test both tissue and liquid samples, helping oncologists to make confident,
informed treatment decisions for patients with advanced NSCLC”, said Kai te Kaat, Vice
President, Head of Global R&D Molecular Diagnostics at QIAGEN. “With this launch, we
continue to further advance our Precision Medicine portfolio by covering new clinically
relevant mutations such as C797S that further improve patient outcomes.”
Molecular Microbiology
QIAGEN’s legacy molecular test business is based on the artus brand products from
Gesellschaft molekularbiologische Diagnostik und Entwicklung mbH (Germany) that was
acquired in 2005. The artus RealArt assay range has been developed for use on a variety of
open architecture detection platforms including the Roche LightCycler, the ABI Taqman
and the RotorGene from Corbett Research. artus' portfolio spans over 60 tests including 30
CE marked assays for the detection of a variety of viral and bacterial pathogens such as
SARS, Herpes simplex virus -1/-2, Epstein-Barr-virus, West Nile virus, malaria and
Salmonella. The portfolio also includes select assays for genotyping and veterinary
medicine and a strong pipeline of complete panels for various disease profiles.

Expanding on this PCR-based business, QIAGEN’s QIAstat-Dx system can deliver Sample
to Insight processing of even the most challenging samples including tissue samples in
pathology, liquid or difficult-to-handle sputum samples in infectious disease, with direct
onboard swab processing.
QIAGEN reported that the system is the only multiplex syndromic testing system based on
real-time PCR (polymerase chain reaction) technology that can process up to 48 targets and
is designed with the additional capability to process immuno-assays. This system also
offers real-time PCR tests in oncology and transplantation.
The artus T. vaginalis QS-RGQ Kit extends the STI detection capabilities of QIAsymphony
RGQ and adds to the platform’s menu. The QIAsymphony family of instruments features
30 different CE-IVD marked tests, including key market differentiating assays for
pathogens important in transplant settings (BKV, CMV, EBV, VZV) as well as bloodborne
viruses (HIV-1, HCV and HBV).
In March 2021, QIAGEN launched QIAcube Connect MDx platform. The device allows
labs to use IVD and more than 140 other QIAGEN standard protocols for automated
sample processing.
Prenatal Testing
In March 2018, QIAGEN and Natera (San Carlos, CA) signed a 10-year agreement to
develop cell-free DNA assays for use on QIAGEN's GeneReader next-generation
sequencing system, for the purposes of prenatal screening. The assays is designed for use
with maternal blood samples and builds on QIAGEN's PaxGene cell-free DNA collection
and sample processing technology. The tests are expected to selectively differentiate fetal
placental DNA from maternal background DNA to test whether a baby is at higher risk for
common genetic disorders.
The partners are focused on establishing a complete sample-to-answer workflow on the

research-use-only GeneReader NGS system and are validating the sample prep workflow
using Natera's Constellation software, which is also accessible to assay users through
QIAGEN's Clinical Insights bioinformatics software. The software also provides
personalized risk reports for healthcare and genetic counseling.

For preterm birth risk, QIAGEN acquired Parsagen Diagnostics (Boston, MA) that had
developed the PartoSure test. In April 2018, QIAGEN received FDA clearance to market
PartoSure, a rapid test for assessing the risk of spontaneous preterm birth in patients with
symptoms of preterm labor. The FDA clearance follows the launch of the test in more than
35 countries across Europe, the Middle East, Asia and Latin America. The five-minute
non-invasive strip test detects placental alpha microglobulin-1 (PAMG-1) in patients
presenting with signs and symptoms of preterm labor. The PartoSure test is a rapid, point-
of-care test, performed with a simple sample collection procedure that does not require a
speculum examination or specialized equipment for sample analysis.
PartoSure added to QIAGEN’s comprehensive Sexual and Reproductive Health portfolio,

which includes the AmniSure ROM Test, the world’s leading assay for rupture of
membranes (ROM); differentiated core technologies and bioinformatics solutions for non-
invasive prenatal testing (NIPT); and the digene HC2 HPV Test to screen for human
papillomavirus (HPV) and protect women from cervical cancer.
Next Generation Sequencing
The GeneReader NGS System provides a Sample to Insight NGS workflow for laboratories
worldwide to take advantage of the power of NGS technology. The system’s integrated
bioinformatics for analysis and interpretation of NGS data, as well as a family of gene
panels under the GeneRead QIAact brand, enable laboratories to identify gene variations
linked to diseases and gain actionable molecular insights. QIAGEN continues to add
content for GeneReader, with a pipeline of potential future tests in areas such as oncology,
prenatal testing, infectious disease genotyping, and customized panels for specific needs.
Integrated bioinformatics provide streamlined, cloud-based analysis and interpretation. The
current version of the GeneReader NGS System is available in the United States for
research use only (RUO).
QIAGEN’s QIAGEN Clinical Insight (QCI) is an integrated solution for NGS analysis and
interpretation in clinical settings. QCI includes QIAGEN’s Human Gene Mutation
Database (HGMD), a resource containing comprehensive data on inherited disease
mutations for genetic and genomic research. HGMD offers research and clinical labs a
comprehensive and easy-to-use database to connect disparate genetic and clinical findings
and identify inheritance patterns.

In June 2019, the company launched a new NGS panel for rare and inherited diseases with
advanced informatics for complete Sample to Insight solution.
In October 2019, QIAGEN launched the QIAseq FastSelect. QIAseq FastSelect technology
consistently removes high levels of ribosomal RNA from mammalian samples through 14
minutes of interaction with the FastSelect RNA removal reagent.
In October 2020, the company launched the QIAseq Human Exome TR Insights. The
product is an innovative solution combining high-performance chemistry with robust
bioinformatics to enable customers to sequence and analyze multiple types of genomic
variation across the entire human exome. This integrated research solution offers rapid
preparation of next-generation sequencing (NGS) exome libraries, robust sequence data
analysis, and industry-leading variant interpretation capabilities.
In June 2021, QIAGEN entered into a partnership with Verogen to offer the broadest
portfolio for human identification, including NGS solutions.
Digital PCR
The company’s dPCR offering is based on the acquisition of Netherlands-based

Formulatrix (Boston, MA) in an agreement set to be completed mid-2019. QIAGEN is in
the advanced stages of development using its technologies and automation, with
Formulatrix’s key dPCR assets. Formulatrix has been developing Constellation, a low-cost
the microtiter-plate-based digital PCR system that it was positioning as a compromise
between expensive droplet-based digital PCR systems and traditional plate-based real-time
PCR platforms.
Commenting on the announcement, QIAGEN said: “The addition of a digital PCR

platform is a logical evolution for our PCR portfolio. As the use of digital PCR continues to
emerge and gains utility across a wide range of applications in Life Sciences, we plan for
expansion into applications for Molecular Diagnostics.”
In January 2022, QIAGEN announced several new collaborations to its digital PCR
platform QIAcuity. A collaboration with Atila BioSystems aims to provide non-invasive
prenatal testing solution to QIAGEN’s dPCR franchise and a co-marketing agreement with
German start-up ACtome with extends QIAcuity’s reach beyond genomics into proteomics.

Liquid Biopsy
QIAGEN has been pioneering the use of liquid biopsy-based companion diagnostics as a
less-invasive option to complement surgical biopsies for genomic profiling of cancers.
QIAGEN is expanding its industry-leading portfolio of liquid biopsy solutions addressing
all major technologies including cell free DNA, exosomal analytes and circulating tumor
cells.
In March 2019, QIAGEN launched novel liquid biopsy solutions and next generation
sequencing (NGS) panels with integrated bioinformatics to support advances in cancer
research. Among the new solutions are bundles for all QIAseq and QIAact DNA panels for
next-generation sequencing (NGS), integrating its CLC Genomics Workbench and
QIAGEN Clinical Insight-Interpret software with these assays for seamless secondary
analysis and tertiary interpretation of complex genomic data.
QIAGEN introduced its exoRNeasy Midi and Maxi Kits for isolation of exosomes and
other extracellular vesicles from urine and other samples, as well as the miRNeasy 96
Advanced QIAcube HT Kit for automated purification of total RNA, including miRNA,
from serum and plasma samples. These are two novel liquid biopsy workflows for cancer
research designed to enable non-invasive extraction and purification of ribonucleic acid
(RNA).
In March 2019, QIAGEN launched new options for customers to streamline NGS analysis
and interpretation by bundling QIAGEN’s bioinformatics solutions with preconfigured
QIAseq DNA panels and custom panels for use on any sequencing platform, as well as with
QIAact targeted gene and custom panels for use on QIAGEN’s GeneReader NGS System.
The new assay-and-software bundles include QIAGEN’s CLC Genomics Workbench and
QIAGEN Clinical Insight-Interpret (QCI-I) for QIAseq DNA panels and QCI-I for QIAact
panels. QIAGEN’s GeneReader Sample to Insight NGS system already includes QIAGEN
Clinical Insight-Analyze (QCI-A) for data analysis.
COVID-19
In February 2020, QIAGEN shipped its newly developed QIAstat-Dx Respiratory 2019-
nCoV test kit to four hospitals in China. The QIAstat-Dx Respiratory 2019-nCoV Panel is a
new version of the existing QIAstat-Dx Respiratory Panel for differential analysis of 21
viral and bacterial pathogens in respiratory syndromes. Once the SARS-CoV-2 genome was

sequenced in January, QIAGEN developed two highly sensitive assays to detect SARS-
CoV-2 targeting ORF1b and the E gene. The addition of these targets provides parallel
tools for combined detection of the novel coronavirus with increased sensitivity. The test
was CE marked in March 2020 and received EUA authorization from FDA for US. It was
the first and only syndromic solution integrating detection of SARS-CoV-2.
In August 2020, the company launched a digital test in the U.S. for rapid detection of
SARS-CoV-2 antibodies after securing FDA EUA authorization.
In September 2020, QIAGEN launched the QIAreach SARS-CoV-2 Antigen Test that was
developed in conjunction with Ellume. The test provides results in 15 minutes. Two
versions of the Antigen Test were US launched in November 2020– one for labs and one
for point-of-care (POC) use.
In November 2020, QIAGEN launched NeuMoDx multiplex test. QIAGEN has launched
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage in the European Union and in the U.S.
with FDA EUA. QIAGEN at that time was the only company to be able to offer fast
singleplex and multiplex PCR tests as well as a fast syndromic solution (QIAstat-Dx),
providing customers with a broad variety of PCR-based testing options.
In March 2021, QIAGEN received FDA EUA for NeuMoDx Multiplex test for Flu A-
B/RSV/SARS-CoV-2.
In April 2021, QIAGEN launched artus Prep&Amp as Ce-marked SARS-CoV-2 test.

QIAGEN’s innovative artus SARS-CoV-2 Prep&Amp UM Kit integrates a liquid-based
sample preparation that takes no more than two minutes with the provided real-time PCR
assay.
In May 2021, QIAGEN received FDA EUA for QIAreach Anti-SARS-CoV-2 Total Test. It
is an easy-to-use digital test to detect SARS-CoV-2 antibodies.
In August 2021, QIAGEN received FDA EUA for its QIAreach SARS CoV-2 Antigen Test
which is a portable test that can detect SARS-CoV-2 antigen in people with active
infections in 2 to 15 minutes.
In November 2021, the company launched its expanded QIAstat-Dx testing menu with the
respiratory four-plex panel that differentiates between flu, RSV and SARS-CoV-2.

In January 2022, QIAGEN stated it is working with genetic laboratories to increase

COVID-19 testing capacity with its artus SARS-CoV-2 Prep&Amp UM Kit. The kit uses
liquid-based sample preparation technology to cut processing times for PCR results.

Quidel Corporation (QuidelOrtho)
San Diego, CA
www.quidel.com
Table 4-24: Quidel Revenue History ($ million)
2018 2019 2020 2021
Total revenues $522 $535 $1,662 $1,699
In May 2022, Quidel completed the acquisition of Ortho Clinical Diagnostics. The new
company formed by the completion of the transaction is QuidelOrtho. The new company
will be headquartered in San Diego, California and has approximately 6,000 employees.
Together, the company revenues reached $3.5 billion in 2021.
Revenues for 2021 totaled $1,699 million increasing 2.2% over 2020. Revenues increased
during 2021 due to strong demand for COVID-19 rapid immunoassay products for both
Sofia and QuickVue, with QuickVue sales increasing exponentially, including all molecular
lines- Lyra, Solana, and Savanna. Revenues for COVID-19 products increased 42% to
$1,267 million in 2021 up from $891 in 2020.

Figure 4-13: 2021 QIAGEN IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
The following is a breakdown of Quidel’s revenues as provided by the company.
Table 4-25: Quidel Diagnostic Revenues by Segment ($ million) est
2018 2019 2020 2021
Rapid Immunoassay $183 $192 $1,145 $1,198
Cardiac Immunoassay -- $267 $243 $256
Specialized Diagnostic Solutions $53 $55 $51 $45
Molecular Diagnostic Solutions $19 $22 $223 $200
Quidel Corporation markets diagnostic applications in infectious diseases, women’s health

and gastrointestinal diseases. The company sells its products for professional use in
physician offices, hospitals, clinical laboratories, reference laboratories, universities, retail

clinics and wellness screening centers. Its products are marketed in the United States
through a network of national and regional distributors, and a direct sales force.
Internationally, it sells and markets primarily in Japan and Europe through distributor
arrangements.
Marketed under the Sofia, QuickVue, D3 Direct Detection and Thyretain brand names, as
well as under the new Solana, AmpliVue and Lyra molecular diagnostic brands, Quidel's
products aid in the detection and diagnosis of many critical diseases and conditions,
including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy,
thyroid disease and fecal occult blood.
Quidel's acquired the Alere Triage system of tests that comprises a rapid test menu that
offers a diverse quantitative immunoassay menu for BNP, CK-MB, d-dimer, myoglobin,
troponin I and qualitative TOX Drug Screen.
Immunoassays
Quidel Corporation markets POC and lab-based immunoassays under the QuickVue, D3
Direct Detection and Thyretain leading brand names, as well as under the new Sofia brand.
The portfolio includes tests for influenza, respiratory syncytial virus, fecal occult blood,
Strep A, pregnancy, thyroid disease, bacterial vaginosis, infectious mononucleosis, HSV,
H. pylori, and chlamydia.
Sofia is the brand name for Quidel's next-generation, immunoassay system, an automated
immunofluorescence-based (FIA) lateral flow test. The Sofia Analyzer and Sofia FIA
assays combine Kinetic Check Technology, fluorescent chemistry, advanced lateral flow
technology, and failure alert and fail-safe systems quantitative assays. Quidel reported that
the instrument is designed to quickly incorporate software upgrades for new analyte-
specific algorithms as the Sofia menu of products expands. The Sofia analyzers and assays
combine unique software and fluorescent chemistry to yield an automatic, objective result
that is readily available on the instrument’s screen, in a hard-copy printout, and in a
transmissible electronic form that can network via a laboratory information system to
hospital and medical center databases.
Quidel reported that the strategy for Sofia is based on the fact that professionals would
prefer rapid point-of-care assays that could be objectively interpreted by an instrument in
contrast to visual read lateral flow tests. The FDA cleared and CLIA Waived Sofia system

is designed to provide a diagnostic result within five minutes of application of the patient's
specimen. The Sofia immunoassays presently for sale include tests for Legionnaires’
disease, Influenza A+B, Strep A and RSV.
Quidel received FDA clearance to market its point-of-care Sofia Lyme fluorescent
immunoassay (FIA) for use with Sofia 2 instrument. The test is intended for use with either
the Sofia or Sofia 2 analyzer to aid in the diagnosis of Lyme disease. The Sofia Lyme
Assay is the fourth 510(k) cleared Sofia test for use on the Sofia 2 system, which includes
the Sofia Influenza A+B Assay, the Sofia RSV Assay, and the Sofia Strep A+ Assay.
The Sofia 2 is a bench-top immunoassay analyzer that offers higher- and lower-volume
utilization than the first iteration of the platform. It received FDA clearance for market in
March 2017. Test results are available in 3 minutes. Sofia 2 also integrates ethernet
connectivity and its barcode scanner within a smaller footprint than the legacy Sofia
instrument. Quidel markets Sofia immunoassays to aid in the diagnosis of Lyme disease,
vitamin D and infections including Influenza A+B, Respiratory Syncytial Virus (RSV),
Group A Streptococcus, Legionella, and S. pneumoniae.
Sofia 2 also integrates wireless connectivity and its barcode scanner within a smaller
footprint than the legacy Sofia instrument. The Sofia 2 system also comes connected to
Virena, Quidel’s data management system, which provides aggregated, de-identified testing
data in near real-time.
Rapid Immunoassays
In May 2017, Quidel completed its acquisition of the InflammaDry and AdenoPlus
diagnostic businesses from RPS Diagnostics. InflammaDry and AdenoPlus were RPS’ only
products. They are rapid, lateral-flow based, point-of-care products for the detection of
infectious and inflammatory diseases and conditions of the eye.
InflammaDry detects elevated levels of MMP-9, an inflammatory marker for dry eye.
AdenoPlus is a test that differentiates between a viral and bacterial infection of acute
conjunctivitis. Both products are CE marked, FDA-cleared, and CLIA-waived.
InflammaDry and AdenoPlus revenues will be reflected in Quidel’s immunoassay revenue
category.

Quidel received FDA clearance to market for its CLIA Waived QuickVue Influenza A+B
assay for the rapid, differential detection of influenza types A and B. The test identifies
and differentiates influenza type A and B in approximately 10 minutes. It is used for the
qualitative detection of influenza type A and type B antigens directly in nasal swab and
nasopharyngeal swab specimens from symptomatic patients.
The Solana Business
Quidel reported that the commercial introduction of Solana has broadened Quidel’s
molecular strategy to include instrumented systems and has grown the number of its
molecular platforms that are both FDA cleared and available commercially. Quidel
reported the Solana reagent kit revenue doubled from 2017 to 2018 due in part to new
HSV/VZV and C. difficile products.
Quidel’s other FDA cleared molecular solutions include the AmpliVue non-instrumented
system for lower-volume moderately complex labs, and Lyra reagents for higher
throughput, highly complex laboratories that are compatible with existing PCR
infrastructure.
The Solana molecular platform leverages Quidel's Helicase-Dependent Amplification

(HDA) technology, and in some tests a Reverse-Transcriptase HDA that is resident in
Quidel's AmpliVue molecular product line to generate a fast test result. Solana can process
up to 12 patient samples in each 45-minute run.
Quidel has reported that it is working with one of its larger distribution partners in the U.S.
on a plan to increase Solana sales. The Solana molecular platform processes up to 12
different assays or samples in each batched run, and the menu for the instrument also
includes Quidel's Influenza A+B, Strep Complete (Groups A+C/G), RSV+hMPV, HSV
1+2/VZV, Trichomonas, and C. difficile tests.
The Solana Trichomonas assay received CE Mark and is Quidel's second molecular
infectious disease diagnostic test to receive FDA 510(k) clearance in the Solana format.
Quidel received FDA clearance to market the Solana RSV + hMPV assay that can detect
and differentiate respiratory syncytial virus and human metapneumovirus. The assay
detects viral RNA from nasal and nasopharyngeal swabs and runs on the firm's Solana
molecular testing instrument. It requires no upfront extraction of RNA and generates a

result in approximately 45 minutes, The RSV and hMPV assay also uses a novel reverse-
transcriptase HDA that is used in Quidel’s AmpliVue molecular product line to generate
fast and accurate test results. The assay received the CE Mark in August 2017.
Quidel received FDA clearance to market its Solana GBS Assay for the direct, qualitative
detection of Group B Streptococcus from enriched broth cultures of specimens from
antepartum women. The Solana GBS Assay is an easy-to-use, molecular diagnostic test
that generates an accurate result from either LIM or Carrot enrichment broth cultures of
vaginal/rectal swabs from antepartum women following 18 to 24 hours of incubation.
Quidel received FDA clearance to market the Solana Bordetella Complete Assay, a
molecular diagnostic assay to detect bacterial strains that cause whooping cough. The
assay also detects and differentiates Bordetella pertussis and Bordetella parapertussis in
nasopharyngeal swabs. The test runs on Quidel's Solana system, which uses helicase-
dependent amplification and processes up to 12 samples per batched run.
Molecular – Savanna
Savanna is a cartridge-based, sample-to-answer system that can run both real-time PCR and
isothermal helicase-dependent amplification assays. According to Quidel the Savanna
system would offer CLIA Waived sample-in result-out mini panels (4 to 8 analytes)
including a STD panel, pharyngitis panel, respiratory panel, HSV / VZV / Syphilis panel
and vaginitis panel.
COVID-19
In March 2020, Quidel received FDA EUA for its Lyra SARS-CoV-2 Assay, a RT-PCR for
qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or
oropharyngeal swab specimens. It also received CE Mark in the EU and authorization in
Canada.
In April 2020, Quidel received FDA EUA authorization for Lyra Direct SARS-CoV-2
assay to allow direct sample processing. The assay will be run on the same six different
instruments as the Lyra SARS-CoV-2 Assay.
In May 2020, the company received FDA EUA for its Rapid antigen COVID-19 diagnostic
assay. Sofia 2 SARS Antigen FIA is a rapid point-of-care test to be used with the Sofia 2

Fluorescent Immunoassay Analyzer for the rapid detection of SARS-CoV-2 in nasal or

nasopharyngeal specimens from patients meeting the CDC criteria for suspected COVID-
19 infection. Additionally, in May, the company received FDA EUA authorization and CE
Mark for Lyra Direct SARS-C-oV-2 Assay for molecular detection of COVID-19 without
extraction step.
In June 2020, Quidel received an amended FDA EUA for its rapid antigen COVID-19
assay using Sofia 1 instrument. Also, the company received BARDA funding to develop a
POC assay that includes COVID-19.
In October 2020, Quidel received FDA EUA for the first rapid antigen ABC test. The Sofia
2 Flu+SARS Antigen FIA is a rapid POC test to be used with the Sofia 2 Fluorescent
Immunoassay Analyzer. The test provides a simultaneous qualitative detection and
differentiation of the nucleocapsid protein antigens from SARS-CoV-2 and influenza A
and B .
In December 2020, the company received FDA EUA for QuickVue SARS Rapid Antigen
Test. The test is a POC assay for the rapid, qualitative detection of the nucleocapsid protein
antigen from SARS-CoV-2. Additionally, in December, the company received FDA EUA
for moderately complex Solana SARS molecular test. Solana SARS-CoV-2 Assay, an
isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) assay is
intended for the qualitative detection of nucleic acid from SARS-CoV-2.
In March 2021, Quidel received FDA EUA for QuickVue At-Home COVID-19 Test. The
test is designed for the qualitative detection of the nucleocapsid protein antigen from
SARS-CoV-2. This test is authorized for prescription home use with self-collected anterior
nares (NS) swab specimens. The test was also authorized for screening use with serial
testing.
In May 2021. Quidel formed a retail collaboration with Walgreens to provide OTC
QuickVue AT-Home COVID-19 Tests. The tests are also available on Amazon.
In September 2021, Quidel announced that its QuickVue AT-Home COVID-19 test will be
available to consumers in CVS Pharmacies throughout the United States and online.
In 2022, Quidel introduced QVue Business, a mobile application that provides at-home
tests for employees using QuickVue At-Home OTC COVID-19 tests and a reporting
system for employers to help track COVID-19 results within the workplace.

PerkinElmer
Waltham, MA
www.perkinelmer.com
Table 4-26: PerkinElmer Revenue History, 2017-2021 ($ million, estimated)
2017 2018 2019 2020 2021
Total Diagnostics $679 $1,080 $1,137 $1,783 $1,951
Diagnostic revenue for 2021 reached $1,951 million, a 9.4% increase over 2020’s $1,783
million. The increase was due to increased demand for COVID-19 product offerings.
Figure 4-14: 2021 PerkinElmer IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions)
estimated
The following is an estimate of PE’s diagnostics revenues in selected segments.

Table 4-27: PerkinElmer Diagnostic Revenues by Segment, 2017-2021 ($ million) est
2017 2018 2019 2020 2021
Newborn/reproductive health $407 $432 $435 $387 $451
Immunoassays $170 $486 $532 $982 $1,024
Molecular microbiology - - - $359 $401
Genomics/NGS $102 $162 $170 $339 $477
PerkinElmer, Inc. is focused on human and environmental health and has been a leader in
the field of prenatal and newborn screening for more than 30 years. PerkinElmer also
provides immunoassays, genetic screening, drug discovery, life science research, and
analytical solutions. PerkinElmer’s diagnostic offerings include: prenatal, neonatal and
infectious disease screening, along with molecular diagnostics solutions, through its wide
range of instruments, reagents and assay platforms, and software. The company also
provides private cord blood and cord tissue preservation to families through ViaCord LLC.
PerkinElmer provides DNA/RNA sequencing services to accelerate target identification,

biomarker discovery, and diagnostic applications. The lab provides end-to-end sequencing
and bioinformatics services.
The DELFIA Xpress screening platform is a complete solution for prenatal and maternal
health screening and is supported by kits for both first and second trimester analyses for
prenatal screening and clinically validated LifeCycle software.
In April 2019, PerkinElmer acquired Cisbio Bioassays. For the last 20 years, Cisbio has
become a leading Life Sciences company that develops, manufactures, and markets high
quality kits and reagents for the drug discovery and life science markets used by
pharmaceutical, biotechnology, academia and contract research organizations worldwide.
Cisbio’s range of kits and reagents are complementary to PerkinElmer’s Alpha, DELFIA
and LANCE assay technologies, which are used in drug discovery and screening
applications.

In May 2021, the company reached an agreement to acquire Immunodiagnostic Systems

Holdings. Through this acquisition, the company is able to grow its diagnostic business.
Additionally, in May, PE also reached an agreement to acquire Nexcelom Bioscience.
Nexcelom is a provider of automated cell counting instruments, image cytometry
workstations, assays and a variety of cell reagents, consumables, and fit-for-purpose cell
counting method selection and development instructions that follow ISO Cell Counting
Standards and aid in the development of cell and gene and immuno-oncology therapies,
virology drugs and vaccines.
In June 2021, the company agreed to acquire SIRION Biotech, a provider of viral vector-
based technology.
Diagnostics
PerkinElmer’s Diagnostics business group focuses on reproductive health, infectious

disease testing and genomics offerings for oncology and other molecular tests through its
broad range of instruments, reagents, assay platforms and software offerings.
With the additions of EUROIMMUN and Tulip, as well as RHS (genomics) and others,
PerkinElmer commented that the Diagnostics business has evolved from a business focused
on newborn screening and centered around the mother and child to a broader specialty
diagnostics provider.
PerkinElmer received FDA clearance to market the EUROPattern microscope for use with
EUROIMMUN’ s IFA Mosaic assays including the ANCA Mosaic that is designed as
indirect immunofluorescence test for the qualitative or semi-quantitative determination of
anti-neutrophil cytoplasmic antibodies (ANCA) of immunoglobulin class IgG in human
serum. The EUROPLUS Granulocyte Mosaic EUROPattern assay allows for additional
monospecific detection of anti-PR3, anti-MPO and anti-GBM IgG antibodies. The
company’s IFA Mosaic assays, together with the FDA-cleared EUROPattern microscope,
are used to aid in the diagnosis of ANCA-associated vasculitis (AAV).
EUROIMMUN’s proprietary BIOCHIP technology offers the ability to provide

differentiation of cANCA and pANCA, detection of any co-existing ANA and
monospecific confirmation via EUROPLUS antigen dots (PR3, MPO and GBM)—all in
the same well. The fully automated EUROPattern system for computer-aided

immunofluorescent microscopy allows for faster processing by acquisition of digital images

within 13 seconds per image and subsequent automated classification/evaluation of results.
In July 2019, PE and EverlyWell entered into a collaboration to accelerate at-home testing.
By adding PE’s CLIA-certified and CAP-accredited lab facilities to EverlyWell’s network.
PerkinElmer launched EUROIMMUN Aspergillus Antigen ELISA in August 2019. The

enzyme-linked immunosorbent assay is specifically designed to detect the Aspergillus
antigen galactomannoprotein and assist in distinguishing invasive aspergillosis (IA).
Sequencing /Genomics
GenePrism: Actionable Insights leverages PerkinElmer’s longstanding diagnostics

expertise and state-of-the-art clinical genomics program. The DNA from individuals that
purchase GenePrism is sequenced by Helix, then results are interpreted by board-certified
medical geneticists at PerkinElmer Genomics using ODIN (Ordered Data Interpretation
Network), PerkinElmer’s proprietary high-throughput software platform. Further,
GenePrism: Actionable Insights analyzes each of the 59 genes in its entirety—including
BRCA1 and BRCA2. Free genetic counseling sessions from Genome Medical are included
to ensure customers understand their results fully and in the correct context.
10x Genomics and PerkinElmer announced a partnership to develop a workflow that

combines PerkinElmer's automation technology with 10x Genomics' linked-reads for
exome and whole-genome sequencing. The workflow is expected to enable large-scale
studies from samples like saliva and archived dried blood spots. The collaboration
combines PerkinElmer's Chemagic nucleic acid extraction technology and Sciclone
automation platform with the 10x Genomics' Chromium instrument. PerkinElmer stated:
“The combination of 10x Genomics’ advanced technology and the precision automation
provided by PerkinElmer’s portfolio will potentially enable a significant increase in sample
numbers and elucidate important genomic variants that are associated with specific
phenotypic traits or the progression of disease.”
PE launched the Chemagic Prime instrument, a streamlined, walk-away sample processing

solution that offers automated nucleic acid isolation and assay setup by combining
PerkinElmer’s Chemagic 360 instrument with the JANUS automated liquid handling
system. The Chemagic Prime instrument uses magnetized rods rather than magnetic plates
to separate nucleic acids from solutions. According to PE, transferring the magnetic beads

instead of the process solutions reduces contamination risk and isolates higher purity, more
intact DNA and RNA. By incorporating additional liquid handling capabilities, the
Chemagic Prime instrument also automates primary sample transfer, normalization, and
setup of PCR assays and NGS libraries. The Chemagic Prime instrument can pair with
PerkinElmer’s reagent kits for isolating nucleic acids from a variety of human samples
including whole blood, saliva, plasma, tissues, FFPE samples, and feces.
PerkinElmer announced its acquisition of RHS Limited (Australia). RHS's primary

platform, DOPlify, performs whole-genome amplification of a small number of or single
cells. Its next-generation sequencing workflow, PG-Seq, and its microarray workflow,
EmbryoCellect, use DOPlify, and have been specifically designed to genetically screen IVF
embryos.
In April 2019, PerkinElmer partnered with Helix to promote Helix’s DNA marketplace,
GenePrism: Actionable Insights, a clinical-grade DNA test available to health individuals
that analyzes all 59 medically actionable genes identified by the American College of
Medical Genetics and Genomics.
Helix has developed a marketplace for DNA-powered products where people can explore
diverse and uniquely personalized genome search. The company operates a CLIA-certified
and CAP-accredited next-generation sequencing lab in San Diego powered by Illumina
next generation sequencing technology.
Liquid Biopsy
In November 2018, PerkinElmer and Precipio signed an agreement to jointly offer

Precipio’s ICE COLD-PCR (ICP) mutation enrichment technology with PerkinElmer's
NextPrep-Mag cell-free DNA isolation kit, Janus G3 liquid handling workstation, and
Chemagic MSM I, Chemagic 360, and Chemagic Prime platforms.
Precipio and PerkinElmer anticipate providing an automated cell-free DNA analysis

workflow alongside mutation enrichment technology in ICE COLD-PCR to enable lab-
based liquid biopsy testing. ICE COLD-PCR is a non-allele specific mutation multiplexed
enrichment technology developed at the Dana Farber Cancer Institute and licensed
exclusively to Precipio that can be used on any downstream DNA sequencing platform and
on any sample type.

Histology
PerkinElmer launched its Vectra Polaris Automated Quantitative Pathology Imaging

System, a multi-modal tissue imaging system. The Vectra Polaris system integrates high
throughput, seven-color multispectral imaging with whole-slide scanning in a digital
pathology workflow to support the quantification and analysis of tissue sections that are
stained with multiple immunohistochemical stains.
According to PerkinElmer, this helps scientists assess biomarkers that probe deeper into the
biology occurring in the immune system and cancer by detecting multiple cell types and
their functional states, while also allowing researchers to determine their spatial
distributions.
The Vectra Polaris system is part of PerkinElmer's Phenoptics workflow solution for
quantitative pathology research, which enables exploration of the interaction between
tumors and immune cells to obtain a deeper understanding of disease mechanisms.
Prenatal Business
PerkinElmer is a long-time contributor to fetal and maternal health and neonatal screening
for inherited disorders that are offered through the company’s network of company-owned
laboratories.
PerkinElmer marked the company’s entrance into the market for non-invasive prenatal
testing (NIPT) with the acquisition of Vanadis Diagnostics, AB. Based in Sweden,
Vanadis was developing a novel solution for NIPT based on digital analysis of cell-free
DNA that was designed to provide automated testing for routine use by high-throughput
biochemistry labs as well as genetic labs.
PerkinElmer received FDA clearance to market the NeoLSD MSMS kit for screening
common lysosomal storage disorders in newborns.
In October 2019, PE launched PG-Seq Rapid Non-Invasive Preimplantation Genetic

Testing for Aneuploidy. The solution tests for chromosomal abnormalities during IVF
treatment.

In December 2019, PE launched the first FDA approved assay kit to screen for Duchenne
MD in newborns. The GSP-Neonatal Creatine Kinase kit is the first commercially available
assay for screening newborns affected by DMD.
In June 2020, PE launched the DELFIA Xpress sFlt-1 kit. The kit enables short term
prediction of pre-eclampsia and aid in diagnosis in the second and third trimester.
Lab Services
Through its integrated laboratories in the U.S., India and China, PerkinElmer offers a
global genomic lab-testing platform that performs screening and diagnostic testing,
specializing in newborn screening and high throughput next generation sequencing for rare
inherited diseases,
In the U.S. PerkinElmer Genetics has two CLIA-certified clinical laboratories based in
Pittsburgh, PA and Branford, CT that process more than 500,000 samples a year. Its testing
menus include newborn screening, biochemical profiling, second tier molecular
confirmatory testing, Sanger and NGS-based panels, and exome and genome sequencing.
PerkinElmer launched its PerkinElmer Genetics’ clinical genomics service that offers
whole exome sequencing (WES) and whole genome sequencing (WGS) services. These
services are also offered in combination with biochemical profiling targeted for rapid WES
and WGS for genetic disease diagnosis. While initially focused on our newborn and
ViaCord customers, PerkinElmer Genetics has also developed a biochemical and molecular
testing menu to meet the needs of other segments, such as pharmaceutical companies.
PerkinElmer Genetics provides clinical WGS, interpretation services, and diagnostic report
generation to IDG. IDG uses the de-identified genomic and clinical data to support R&D in
hundreds of rare neurological conditions.
PerkinElmer, Inc., expanded its Whole Genome Sequencing (WGS) services to families
that preserve their cord blood and cord tissue with ViaCord. This launch follows the
company’s recent introduction of its clinical WGS services. Parents that choose ViaCord,
PerkinElmer’s cord blood and cord tissue preservation business, have the opportunity to
benefit from a physician ordered WGS test of their child’s DNA via a simple saliva test.
The test examines a broad range of disease-related genes and provides diagnostic findings

contributing to pediatric onset diseases. Additionally, the test reports on pharmacogenetic

variants used to optimize certain drug selection.
Mass Spectrometry
PerkinElmer launched its QSight 210 MD system using tandem mass spectrometry
(MSMS) technology designed to enable laboratories to run hundreds of samples per day.
The QSight MD 210 system provides a complete workflow, from sample preparation to end
result for maximized throughput.
In June 2022, PE launched its GC Platform, an advanced automated gas chromatography

headspace sampler and GC/mass spectrometry solution to help labs operations.
COVID-19
PerkinElmer received FDA EUA for the company’s new coronavirus RT-PCR test, Anti-
SARS-CoV-2 ELISA serology test. Additionally, EUROIMMUN received CE mark for its
EURORealTime SARS-CoV-2. EUROIMMUN is one of the first European manufacturers
of diagnostic tests to provide antibody detection systems to support COVID-19 diagnostics.
In May 2020, FDA provided EUA for its serology test.
In July 2020, PerkinElmer launched a dry blood spot (DBS) based test for SARS-CoV-2
IgG using its GSP/DELFIA platform, enabling processing of up to 5,000 samples per day.
The finger-prick sample collection device allows for both decentralized sample collection
and high-throughput testing. The product is being marketed as a CE-IVD test and received
Emergency Use Authorization (EUA) with the US Food and Drug Administration.
In August 2020, PerkinElmer launched a series of explorer workstations for SARS-CoV-2

testing capable of preparing and running up to 10,000 COVID-19 tests per day.
In October 2020, the company received FDA EUA for its COVID-19 Test kit for Sample
Pooling. Additionally, in November 2020, EUROIMMUN, a PerkinElmer company,
launched the Anti-SARS-CoV-2 QuantiVac ELISA (IgG) to quantify IgG antibodies
against the sARS-CoV-2 S1 antigen.

PerkinElmer received FDA EUA in October 2021, for the PKamp Respiratory SARS CoV-
2 RT-PCR Panel 1 assay. This is a single test that provides simultaneous qualitative
detection of SARS-CoV-2, influenza A, B and RSV from a nasal swab.

Roche Diagnostics
Indianapolis, IN
www.roche.com
Table 4-28: Roche IVD Diagnostics Revenues 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Roche Diagnostics $12,094 $12,977 $12,875 $14,544 $19,433
In 2021, Roche Diagnostics reached revenues of $19,433 million.
Figure 4-15: 2021 Roche IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated

For full-year 2021, Roche Diagnostics revenues grew 32.3% due to sales of COVID-19-
related tests, namely, cobas SARS-CoV-2 PCR test and the SARS-CoV-2 Rapid Antigen
test. Strong momentum from the base diagnostic sales also contributed to growth.
Molecular diagnostic sales increased by 29% driven by the virology business. The Delta
variant continued to create opportunities for COVID-19 testing.
Core lab sales increased by 21% due to its immunodiagnostics businesses with infectious
and cardiac tests as the main contributors.
Point of care sales grew significantly in 2021 up 138%. The SARS-CoV-2 Rapid Antigen
test was the main growth driver.
Diabetes care sales increased 3% and pathology lab sales increased 12%.
Table 4-29: Global Roche IVD Diagnostics Revenues by Type, 2017-2021 (million)
Item/Year 2017 2018 2019 2020 2021
Core/POC $7,292 $7,942 $7,870 $7,756 $11,007
Diabetes $1,996 $2,024 $1,931 $1,781 $1,850
Molecular $1,544 $1,621 $1,750 $3,630 $4,765
Tissue $1,031 $1,137 $1,111 $1,160 $1,315
Sequencing $231 $253 $213 $168 $287
Hematology
The cobas m 511 digital Bloodhound technology facilitates the identifying, counting,
isolating and categorizing white blood cells, red blood cells and platelets, then presenting
the digital images of all these cell types. The Bloodhound technology counts, analyzes
morphology and then classifies every cell in the viewing area to provide a standard
complete blood count (CBC) and 5-part differential and reticulocyte count.

Immunoassays
Roche’s immunoassay cobas and Elecsys systems run more than 80 different
immunoassays for cardiac and infectious diseases, bone markers, thyroid, rheumatoid
arthritis, tumor markers and tests for maternal care. Infectious disease immunoassays
include those for HSV, hepatitis A/B/C, chagas, HIV, CMV, HTLV, rubella, syphilis, and
toxoplasma. In serology, Roche’s patented ECL technology, is a proven and trusted
technology in immunodiagnostics performing more than a billion tests a year.
The Elecsys family of assays is based on Roche’s Elecsys heterogeneous immunoassay

electrochemiluminescence (ECL) technology. The tests can be performed on any of the
cobas modular platforms, including the cobas 4000 and cobas 6000 analyzer series, or the
high-volume cobas 8000 modular analyzer series.
In September 2020, Roche launched the Elecsys HIV Duo immunoassay in the US
following FDA approval in April 2020. Elecsys HIV Duo is an advanced 4th generation
HIV screening test, offering separate HIV antigen and anti-HIV antibody results, as well as
a single combined result. The test has several benefits over traditional 4th generation tests,
not only for the patient, but also for the laboratory and the clinician. The total testing time
is only 18 minutes, allowing rapid results in the case of emergency situations.
Elecsys CSF immunoassays: Establishing the presence of degenerative diseases of the

central nervous system is important when it comes to distinguishing age-related memory
disorders from early-stage dementia. Deposits of β-amyloid peptides (1-42) and
neurofibrillary tangles in the brain are the two earliest changes associated with the
development of Alzheimer's disease and can be detected by different methods. Biomarkers
in the cerebrospinal fluid (CSF) help clinicians detect Alzheimer’s disease, the most
common form of dementia, from an earlier stage.
The Elecsys β-Amyloid (1-42) CSF, Elecsys Phospho-Tau (181p) CSF and Elecsys(R)
Total-Tau CSF immunoassays are in vitro tests for the quantitative determination of
concentrations of the β-amyloid (1-42), phosphorylated tau (181P) protein and total Tau
protein in human cerebrospinal fluid. The markers can be used alone or in combination.
The ElectroChemiLuminescence Immunoassay “ECLIA” is intended for use on Elecsys
and cobas e immunoassay analyzers.
Roche received FDA Breakthrough Device Designation for the Elecsys ß-Amyloid (1-42)
CSF and Elecsys Phospho-Tau (181P) CSF. These in vitro diagnostic immunoassays are for

the measurement of the ß-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal

fluid (CSF) in adult patients with cognitive impairment who are being evaluated for
Alzheimer’s disease (AD) or other causes of dementia in concordance with amyloid PET
visual read result and risk of cognitive or functional decline.
Core Molecular
The cobas 6800 and cobas 8800 systems are fully integrated, automated solutions for
routine molecular testing in the areas of viral load monitoring, blood donor screening,
women’s health and microbiology. Based on PCR technology, the systems allow up to
three tests in the same run with no pre-sorting required. The systems also enable up to
eight hours (cobas 6800) and four hours (cobas 8800) of walk-away time with minimal user
interaction. Roche reported that more than 500 systems have been installed worldwide.
Molecular cobas assays for use on the cobas 6800/8800 Systems include: HIV-1, HIV-
1/HIV-2; HCV; HBV; CMV; HPV and CT/NG plus three next-generation assays for donor
screening: cobas MPX, WNV and HEV.
In May 2019, Roche received FDA clearance to market its cobas TV/MG test for the
detection of Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in
symptomatic and asymptomatic patients.
The test, which runs on Roche's cobas 6800 and cobas 8800 real-time PCR systems,
expands the company's existing test menu and has been validated for use on different
specimen types, including male or female urine, endocervical swabs, and vaginal swabs
collected by clinicians or patients in a clinical setting. Roche added that labs can now assess
a patient sample for TV/MG as well as using the existing cobas CT/NG test for Chlamydia
trachomatis (CT) and Neisseria gonorrhea (NG).
The Cobas MTB test enables the detection of Mycobacterium tuberculosis complex
(MTBC) DNA, while the cobas MAI test enables the direct detection and differentiation of
Mycobacterium avium and Mycobacterium intracellular DNA in symptomatic patients.
Roche’s mycobacteria tests have been validated for use with raw sputum, sputum sediment,
and bronchoalveolar lavage sediment samples. The high sensitivity of the cobas MTB test
enables increased detection of tuberculosis in challenging smear-negative samples.

In December 2020, Roche received FDA approval for the first HIV-1/HIV-2 Qualitative
Test run on the cobas 6800/8800 systems. The test is intended to be used as an aid in
diagnosis of HIV-1/HIV-2 infection. Detection of HIV-1 or HIV-2 nucleic acid is
indicative of HIV-1 or HIV-2 infection, respectively.
In February 2021, Roche received FDA clearance for its cobas BKV Test, which is run on
the cobas 6800/8800 systems. It is able to detect early infection in immunocompromised
transplant patients.
In September 2021, Roche launched three molecular PCR diagnostic tests that
simultaneously detect and differentiate common respiratory pathogens. The tests include:
• Influenza A, Influenza B and RSV
• Adenovirus, human metapneumonia and Enterovirus
• Parainfluenza 1,2,3 and 4
The tests can be run together or individually from a single specimen.
Digital PCR
The digital PCR space now appears poised to become more competitive in the future with
the recent announcement that Roche is a top contributors to developing a six-channel
digital PCR system that competes with leaders Bio-Rad Laboratories and Thermo Fisher
Scientific.
Diabetes Care
Roche Diabetes Care has served the diabetes community for more than 40 years in 100
markets. Roche Diabetes Care is a pioneer in the development of blood glucose monitoring
systems. Under the brand Accu-Chek and in collaboration with partners, Roche Diabetes
Care offers integrated solutions to monitor glucose levels, deliver insulin and track as well
as contextualize relevant data points for therapy management.
In March 2016, Cellnovo Group (Paris, France), a medical technology company marketing
a connected all-in-one diabetes management system, signed an agreement to integrate
Roche Diabetes Care’s Accu-Chek Aviva and Accu-Chek Performa blood glucose

monitoring (BGM) platforms into the Cellnovo diabetes management system, a CE Marked
next generation e-connected handset. The Roche BGM platform replaced the LifeScan
OneTouch Vita BGM currently used. The Cellnovo Diabetes Management System is
compact, tubeless, intuitive and entirely connected Cellnovo’s insulin pump comprises a
mobile touchscreen controller with an integrated blood-glucose meter.
Roche has also expanded its lab-based diabetes testing menu. In January 2017, Roche
received FDA clearance to market the cobas c 513 analyzer and Tina-quant HbA1c Gen. 3
assay. The cobas c 513 analyzer replaces the Cobas Integra 800 CTS and can increase
throughput to 400 patient results per hour. It also features direct results reporting.
In May 2021, the company signed a collaborative agreement with Eli Lilly to integrate data
from the company’s connected insulin pen into Roche’s open ecosystem through the
mySugr app.
In January 2022, Roche launched its cobas pulse system which is the newest generation of
connected POC solutions for professional blood glucose management. The cobas pulse
system is equipped with digital applications that are based on the Android operating
system.
cobas Liat System – POC
Utilizing PCR technology, the cobas Liat System fully automates the testing process,
simplifies workflow and enables healthcare professionals to perform molecular testing in a
variety of settings with minimal training. The Liat system performs real-time PCR in a
tube-based format, using spatial thermal cycling to enable results in 20 minutes or less.
HPV
In March 2020, Roche received FDA approval for CINtec PLUS cytology test as the first
biomarker-based triage test for women whose primary cervical cancer screening results are
positive for HPV using the cobas 4800 HPV Test.
In April 2020, Roche received FDA approval for cobas HPV test for use on the cobas
6800/8800 system to identify women at risk for cervical cancer.

Blood Bank
Roche blood banking business offers a portfolio through personalized lab automation that
integrates nucleic acid testing, serology testing, pre-analytics and IT solutions. Roche also
offers a connectivity of serology and nucleic acid testing. Roche claims to be a leader in
the global blood and plasma molecular (NAT) screening market. Roche's real-time PCR-
based nucleic acid assays have been used since 1998 to screen blood and plasma products.
In September 2019, FDA approved cobas Babesia test for use on the cobas 6800/8800
systems for individual blood donor testing. cobas Babesia detects parasites that live in red
blood cells. This test is an important advancement because the Babesia parasite cannot be
detected in traditional plasma or serum samples. The test is able to detect the four common
species of Babesia and employs the new whole blood collection tube, which simplifies
Babesia sample preparation by consolidating steps within the tube itself to provide an
efficient solution for testing laboratories.
Cancer Companion Testing
Roche’s blood-based companion tests are performed on the cobas 4800 System, which
offers amplification and detection coupled with software that automates results
interpretation and reporting. The cobas 4800 System menu for oncology in the U.S.
includes the cobas EGFR Mutation Test v2, the cobas EGFR Mutation Test, the cobas
KRAS Mutation Test, and the cobas BRAF V600 Mutation Test
In January 2019, Phoenix Molecular Designs (Vancouver, B.C.) and Roche partnered to
develop a molecular diagnostic to help stratify triple-negative breast cancer patients. Roche
developed an assay to detect activation of RPS6KA3, which Phoenix said preliminary data
suggests is present in up to 80% of TNBC patients.
In April 2019, Roche launched VENTANA HER2 Dual ISH companion diagnostic test for
breast and gastric cancer.
In June 2020, Roche received approval for cobas EXH2 Mutation Test as a companion
diagnostic for patients with follicular lymphoma.
In July 2020, FDA approved Roche’s VENTANA HER2 Dual ISH test as a companion
diagnostic to identify breast cancer patients eligible for targeted therapy.

In October 2020, Roche received FDA approval of its EGFR Mutation Test v2 as the first
companion diagnostic test approved for a broad group of therapies treating NSCLC.
In March 2021, Roche received FDA approval of the Ventana ALK CDx Assay as a
companion diagnostic to identify ALF-positive NSCLC patients eligible for treatment with
Pfizer’s Lorbrena. The test is the only IHC test approved by the FDA as a companion
diagnostic for Lorbrena.
In April 2021, Roche received FDA approval for first CDx to identify endometrial cancer
patients eligible for anti-PD1 immunotherapy.
In August 2021, Roche received FDA approval for Ventana MMR RxDx Panel. The test is
the first companion diagnostic test to aid in identifying patients whose solid tumors are
deficient in DNA mismatch repair who may be eligible for Jemperli.
In October 2021, Roche received FDA approval for its Ventana PD L-1 (SP263) Assay as a
companion diagnostic to identify certain non-small lung cancer patients that would benefit
from Tecentriq.
COVID-19
In March 2020, Roche received EUA authorization for cobas SARS-CoV-2 Test. It is
intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19
disease, in nasopharyngeal and oropharyngeal swab samples from patients who meet
COVID-19 clinical and/or epidemiological criteria for testing. Hospitals and reference
laboratories can run the test on Roche’s fully automated cobas 6800 and cobas 8800
Systems, which are widely available in the U.S. and around the world. The product also
received CE marking.
In April 2020, Roche received FDA EUA authorization for its new Elecsys Anti-SARS-
CoV-2 antibody test. The test is designed to help determine if a patient has been exposed to
the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2.
Roche has already started shipping the new antibody test to leading laboratories globally
and will ramp up production capacity to high double-digit millions per month to serve
healthcare systems in countries accepting the CE mark as well as the U.S.

In July 2020, Roche launched its SARS-CoV-2 Rapid Antibody Test for POC testing. The
product was developed in partnership with SD Biosensor. This newly developed SARS-
CoV-2 Rapid Antibody Test is for use in point of care settings and can help healthcare
professionals identify patients that have developed antibodies against SARS-CoV-2,
indicating prior infection.
In September 2020, Roches received FDA EUA authorization for the cobas SARS-CoV-2
Influenza A/B Test for use on the cobas 6800/8800 systems.
In March 2021, Roche launched the cobas SARS-CoV-2 Variant Set 1 Test to detect and
differentiate mutations found in variants of the virus.
In June 2021, Roche was granted FDA EUA for the cobas SARS-CoV-2 Nucleic Acid Test
for use on the cobas Liat System to test both symptomatic and asymptomatic individuals at
the point of care.
The company performed 60+ million COVID-19 tests per month during 2021, worldwide.
In March 2022, Roche and its subsidiary, TIB Molbiol, are pursuing tests that identify the
SARS-CoV-2 subvariants.
In June 2022, Roche received FDA EUA for its cobas SARS-CoV-2 Duo run on the cobas
6800/8800 systems for qualitative result of COVID-19 and quantitative measurement of
viral load.

Siemens Healthineers (Siemens)
Deerfield, IL
www.siemens.com/diagnostics
Table 4-30: Siemens Healthineers IVD Revenues 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Total Diagnostic IVD $4,696 $4,675 $4,630 $4,540 $6,770
Total revenue for diagnostics totaled $6,770 million for 2021, a 49.1% increase over 2020.
Traditionally, Siemens’s revenue is generated 49% N. America, 33% EU, 28% Asia and
ROW.
Figure 4-16: 2021 Siemens Healthineers IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in
millions) estimated

The following is Kalorama’s estimated breakdown of Siemens’ IVD product sales in

selected test segments; Kalorama has taken the liberty to estimate the company’s sales in
2021.
Table 4-31: Global Siemens Healthineers IVD Revenues by Type, 2021 (million)
Item/Year 2021
Immunoassays $3,058
Coagulation $470
Hematology $380
Molecular $562
POC $1,930
Urinalysis $50
Blood Gases $215
Other Rapid COVID $1,240
Siemens’ diagnostics business includes products from Diagnostics Products Corp. (DPC),
the Bayer Diagnostics Division (without Bayer Diabetes Care) and Dade Behring. The
Siemens healthcare business is one of the world's largest suppliers to the healthcare
industry and a major player in medical imaging, laboratory diagnostics, medical
information technology and hearing aids.
The diagnostics division includes products for: clinical chemistry, drug testing,
hematology, coagulation, immunoassay, infectious diseases, microbiology, molecular
diagnostics, plasma proteins, point of care testing, blood gases/electrolytes, and urinalysis.
In addition, Siemens operates a clinical laboratory and offers laboratory informatics and
automation.

Core Lab
In May 2019, Siemens launched its Atellica CH Enzymatic Hemoglobin A1c Assay to
assist clinicians in diagnosing and monitoring diabetes.
Immunoassays
Siemens became a top player in immunoassays via its acquisition of DPC in 2006. Since
its introduction in 1992 by DPC, the IMMULITE family of systems has grown to be a
premier brand in immunoassay testing. The tests complement Siemens' (Bayer) ADVIA
Centaur systems. Together, they have a large global installed base in hospital clinical
laboratories.
Siemens offers an FDA cleared menu of Atellica infectious disease immunoassays

including HIV Ag/Ab Combo (CHIV), HBsAg II, HCV and Syphilis. The HBsAg II
SMART algorithm and the hot zone helps reduce repeat testing and decreases turnaround
time.
The ADVIA Centaur HIV Ag/Ab Combo (CHIV) Assay was also developed,
manufactured, and sold by Siemens Healthcare Diagnostics Inc. for Ortho Clinical
Diagnostics, Inc. and Grifols Diagnostic Solutions Inc.
In January 2020, Siemens Healthineers added fentanyl assay to its Atellica menu. The ARK
Fentanyl Assay extends the detection window to provide the information clinicians need to
triage their patients more appropriately. This is important because fentanyl absorption
occurs at different rates depending upon the type of exposure, and during this time a patient
will typically face suppressed respiratory function and should be closely monitored.
In February 2020, Siemens Healthineers was selected by Quest Diagnostics to be its

preferred supplier for immunoassay testing. As part of the multi-year agreement, which
builds on an existing partnership, upon successful execution of sequenced phases, the
partnership foresees Quest Diagnostics deploying up to 120 Atellica Solution immunoassay
analyzers across 19 esoteric and core laboratories throughout the U.S.

Hematology
The company’s hematology offering is based on its ADVIA Systems that offer a portfolio
of diagnostic assays and gold-standard flow cytometry testing. The CellaVision DM1200
digital cell morphology system is designed to automate the traditional microscopy.
In October 2017, Siemens and HORIBA Medical (Montpelier, France) entered into a long-
term agreement to create new hematology solutions. This alliance provides HORIBA
Medical the opportunity to address the multidisciplinary requirements along with
complimentary innovative technology of Siemens Healthineers. HORIBA Medical will
continue offering innovative technology solutions through its Yumizen 2 brand and current
distribution channels.
In February 2021, Sysmex extended its alliance with Siemens Healthineers for hemostasis
testing. In August 2021, Siemens Healthineers launched INNOVANCE Anti-Xia assay for
heparin and DOAC run on Sysmex CN-3000 and CN-6000 systems
Molecular
Siemens' molecular testing systems provide detection of major infectious diseases,

monitoring of treatment efficacy, and selection of targeted, individualized treatment
options. The combination of infectious disease immunoassay and molecular testing offers a
total solution for diagnosis and monitoring of HIV and hepatitis.
Siemens’ molecular diagnostics business is based in Bayer’s Trugene and Versant

molecular lines of tests and systems. These have been used to sequence viruses (H1N1)
and bacteria (MRSA) and produce quantitative results that may be used to monitor response
to therapy.
The VERSANT kPCR Molecular System provides an automated solution for routine viral
load and laboratory-developed molecular assays in the fields of virology and bacteriology
utilizing kinetic PCR technology. VERSANT kPCR Molecular System delivers
quantitative and qualitative detection across many molecular diagnostic applications. The
new VERSANT MiPLX Software Solution allows multiple assays per sample and run. The
universal DNA and RNA extraction protocol supports a wide variety of sample types.
Closed-tube processing eliminates the need for clean room operations.

The test menu includes: VERSANT HIV-1 RNA 1.0 Assay (kPCR), VERSANT HCV
RNA Qualitative Assay (TMA), VERSANT HCV RNA 1.0 Assay (kPCR), VERSANT
HBV DNA 1.0 Assay (kPCR), VERSANT CT/GC DNA 1.0 Assay (kPCR), VERSANT
CT/GC DNA 1.0 Assay (kPCR), VERSANT HCV Genotype 2.0 Assay (LiPA),
VERSANT HCV Genotype 2.0 Assay (LiPA), TRUGENE HIV -1 Genotyping Assay,
VERSANT HCV RNA 3.0 Assay (bDNA, viral load), VERSANT HIV-1 RNA 3.0 Assay
(bDNA, viral load) and VERSANT HBV bDNA 3.0 Assay (viral load).
Acute Care – POC
In October 2019, Siemens launched its RAPIDPoint 500e Blood Gas System for critical
POC. The system generates blood gas, electrolyte and metabolite results used to diagnose
and monitor critically ill patients.
In December 2020, Siemens received CE marking and FDA clearance for it epoc blood
analysis system – epoc NXS Host. This is a handheld device designed for POC.
COVID-19
In May 2020, the company announced that its received CE mark for its SARS-CoV-2 IgM
and IgG antibodies test. The antibody test is now available on the largest installed base in
the U.S. and one of the largest in the world with 20,000 Siemens Healthineers systems
installed worldwide. This includes the Atellica Solution immunoassay analyzer, which can
run up to 440 tests per hour and enables a result in just 10 minutes. By detecting both IgM
and IgG antibodies, the test provides a clearer clinical picture over a longer period of time
as the disease progresses.
In August 2020, Siemens received FDA EUA authorization for the SARS-CoV-2 antibody
test, which is the first antibody test authorized with a semi-quantitative detection.
In November 2020, Siemens received CE marking for its SARS-CoV-2 IgG antibody Test,
which is designed to measure neutralizing antibodies. The company has submitted and
received FDA EUA authorization. Reliable antibody tests are valuable to measure the
effectiveness of vaccines. The test is available on the Atellica, ADVIA Centaur XP and
XPT families of analyzers.

In January 2021 Siemens received CE marking for its CLINITEST Rapid COVID-19
Antigen test.
In February 2021, the company launched its lab-based SARS-CoV-2 Antigen Assay on the
Atellica Solution and ADVIA Centaur analyzers.
In August 2021, Siemens Healthineers offers a RT, AI-based predictive tool to aid in
identifying patients at risk of progressing to severe outcomes from COVID-19.

Sysmex Corporation
Kobe, Japan
www.sysmex.co.jp
Table 4-32: Sysmex IVD Revenues 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
IVD revenues $2,427 $2,566 $2,667 $2,730 $3,065
Sysmex’s year end is March 31, so the company reported 2021 IVD revenues of $3,065
million.
The reader will note that the sales data as presented here will differ from that reported by
Sysmex.
In 2021, China accounted for approximately 27.5% of Sysmex’s consolidated net sales as
compared to 17% in previous years.
In 2021 Sysmex’s sales were generated 26.9% in Europe, 21.6% in the Americas, 16% in
Japan, 27.5% in China, and 8% in ROW.

Figure 4-17: 2021 Sysmex IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
The following is Kalorama’s estimated breakdown of Sysmex's product sales in selected

test segments ($ million):
Table 4-33: Global Sysmex IVD Revenues by Type, 2017-2021 (million)
Item/Year 2017 2018 2019 2020 2021
Hematology $1,559 $1,646 $1,719 $1,663 $1,879
Coagulation $402 $433 $442 $481 $554
Urinalysis $184 $191 $195 $188 $261
Immunoassay $118 $125 $136 $134 $170
Clinical Chem $25 $29 $27 $28 $29
Flow Cytometry $13 $13 $14 $13 $17
Others $126 $129 $134 $138 $155

Sysmex is an integrated manufacturer of laboratory software and diagnostic systems

involved in the development, production, marketing, and servicing of clinical laboratory
testing devices and reagents. Sysmex’s products are used by medical institutions in more
than 170 countries, with a significant portion of sales concentrated in Europe, the Americas,
Japan, and China.
Since its establishment in 1968, Sysmex had concentrated in hematology and urinalysis.
More recently, Sysmex has expanded its portfolio and now offers clinical laboratory
systemization and solutions, including clinical diagnostics, automation and information
systems. The company is innovating across all of its diagnostic practices, including flow
cytometry, urinalysis and hematology.
At this time, Sysmex has expanded its presence in molecular analysis and liquid biopsy
testing, primarily for cancer based on the establishment of Sysmex Inostics (2015) for next
generation sequencing, flow cytometry from the acquisition of Partec and its partnership
with Riken Genesis for clinical PCR.
Hematology
Sysmex America launched its XN-L automated hematology analyzers in the United States.
The new, smaller XN-L line delivers the same capabilities as the XN-Series to low volume
hematology laboratories. The XN-L analyzers is the first to feature the BeyondCare
Quality Monitor, a new approach to quality assurance. The XN-L automated hematology
analyzers offer a 6-part differential including immature granulocyte analysis (IG) on each
sample - all in a compact footprint.
In addition, the XN-L Series offers optional software licenses for a reticulocyte channel to
aid in anemia management, and body fluid cell counts. For integrated health networks,
common reagents and controls allow standardized testing from high volume core labs to
affiliated clinics and physician office labs.
In February 2021, Sysmex extended its alliance with Siemens Healthineers for hemostasis
testing.
Additionally, the company renewed its agreement for global alliance in the hematology
field with Roche.

For 2021, the 13% growth in the hematology arena was influenced by the XR Series, XQ
series and the relaunch of the XW-100 in the US.
Coagulation
In July 2020, Sysmex launched new products including the Automated Blood Coagulation
Analyzers CN-6500/CN-3500. These new offerings from Sysmex come with a measuring
unit using the chemiluminescence enzyme immunoassay methodology, which the company
cultivated in its Automated Immunoassay Systems HISCL-5000/HISCL 800 (HISCL), on
top of the unique features of the Automated Blood Coagulation Analyzers CN-6000/CN-
3000, making it possible to measure blood coagulation testing parameters, including
molecular markers for blood coagulation with a single device.
Urinalysis
Sysmex has been an innovator in urinalysis. In January 2019, Sysmex America announced
the availability of its first fully automated urine particle counter and digital imaging system,
the UN-2000. By combining urine flow cytometry with digital imaging, Sysmex’s UN-
2000 provides laboratories a standardized process for urine sediment analysis. Using
fluorescence flow cytometry, the UN-2000 offers full automation through walk-away
operation.
The UN-2000 offers consolidated quality control with BeyondCare Quality Monitor
(BCQM). The first quality management system of its kind (according to Sysmex) BCQM
streamlines the end-to-end process of running controls and reviewing results. Red, yellow
and green color-coded alerts intuitively track and annotate quality control. Customers can
access valuable peer group analytics and lot-to-lot quality control management, while
taking the guesswork out of quality control management. BCQM is standard on Sysmex
UN Series automated urinalysis analyzers available in the United States and Canada.
Growth was affected by expanded sales in North America, especially in the United States.
Sysmex acquired additional shares of Astrego Diagnostic AB. Through this acquisition,
Sysmex accelerated the clinical application of a rapid antimicrobial susceptibility test that
Astrego is developing for urinary infections.

Flow Cytometry
In August 2019, the company launched its PS-10 sample preparation system. By
automating complicated sample preparation work for clinical laboratories, the PS-10 results
in providing workflows, which are more efficient and aids in standardizing clinical flow
cytometry testing.
In June 2020, Sysmex launched the PS-10 sample preparation system Flow Cytometer XF-
1600 in North America. The Sysmex flow cytometry portfolio makes it possible for
laboratories to automate the entire process of flow cytometry testing from sample
preparation to the reporting of measurement results.
In November 2020, Sysmex added the CellaVision DC-1 to its portfolio of products for
low-volume hematology labs.
Precision Medicine / Companion Test Diagnostics
In January 2020, the company launched the Ipsogen JAK2 DX reagent. This product is a
gene testing kit that measures the JAK@V617F mutation quantitatively and is for the
diagnosis of hematopoietic tumors such as polycythemia, essential thrombocythemia and
primary myelofibrosis.
In July 2021, Sysmex formed an alliance with QIAGEN to provide cancer CDx that use
ultra-sensitive liquid biopsy NGS technology. Sysmex currently offers the
“OncoBEAMTM5 RAS CRC Kit” as companion diagnostics for colorectal cancer. It uses
highly-sensitive digital PCR technology and is regulatory approved and covered by national
insurance in Japan.

Thermo Fisher Scientific Inc.
Waltham, MA
www.thermofisher.com
Table 4-34: Thermo Fischer IVD Revenues 2017-2021 (millions $)
Item/Year 2017 2018 2019 2020 2021
Clinical Diagnostics & Clinical NGS $3,173 $3,315 $3,335 $5,035 $5,782
Thermo Fisher reported that geographically N. America accounted for 52% of revenues,
Europe 28%, Asia Pacific 17% and ROW 3%.
The company continues to focus on specialty diagnostics including microbiology,

histology, and immunoassays.

Figure 4-18: 2021 Thermo Fisher IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions)
estimated
The following is Kalorama’s estimate of the company’s sales in selected IVD test segments
($ million, estimated):
Table 4-35: Global Thermo Fisher IVD Revenues by Type, 2017-2021 (million)
Item/Year 2017 2018 2019 2020 2021
Clinical products $698 $750 $800 $684 $3,961
Immunoassays $590 $630 $700 $735 $743
Microbiology $520 $550 $600 $1,942 $2,248
Transplant $245 $245 $255 $251 $280
NGS $770 $785 $800 $1,423 $1,821

In the IVD sector Thermo Fisher Scientific Inc. is known under two brands, Thermo
Scientific and Fisher Scientific. Thermo Scientific offers customers a complete range of
high-end analytical instruments as well as laboratory equipment, software, services,
consumables and reagents to enable integrated laboratory workflow solutions. Fisher
Scientific provides a complete portfolio of laboratory equipment, chemicals, supplies and
services used in healthcare, scientific research, safety and education.
In May 2019, the company acquired Brammer Bio, a manufacturer of gene and cell
therapies.
In June 2019, the company divested its interest in its Anatomical Pathology business to
PHC Holdings.
In September 2019, Thermo Fisher Scientific (TFS) completed the acquisition of GSK
manufacturing site in Cork, Ireland.
In January 2021, Thermo Fisher announced its intent to acquire POC molecular business of
Mesa Biotech. Mesa Biotech has developed and commercialized a PCR-based rapid point-
of-care testing platform available for detecting infectious diseases including SARS-CoV-2,
Influenza A and B, respiratory syncytial virus (RSV) and Strep A. Mesa Biotech's patented
technology expands the availability of gold standard nucleic acid PCR amplification to
point-of-care diagnostics.
In February 2021, Thermo Fisher entered into a partnership with Mindray to make two
chemistry analyzers available in the US and Canada for drug screening in clinical and drug
court laboratories.
Immunoassays
In January 2019, Thermo Fisher received FDA clearance to market the ImmunoCAP
Specific IgE blood test for Ara h 6, part of a line of assays for detecting specific peanut
allergen components. Thermo Fisher reported that results from Ara h 6 ImmunoCAP
testing can act as an aid to help specialists and other clinicians better understand patients'
risk factors as part of tailored allergy treatment or management plans.
In April 2019, Thermo Fisher announced the availability of the Thermo Scientific CEDIA
Mitragynine (Kratom) Assay, its newest drugs of abuse test that includes supporting

calibrators and controls. The CEDIA Mitragynine (Kratom) Assay can be run on commonly
used clinical chemistry analyzers. This test is for criminal justice and forensic use only.
Kratom is not currently classified as a controlled substance, but it is listed by the Drug
Enforcement Agency (DEA) as a "drug of concern," since it can result in severe health
effects or even death.
Microbiology
According to Thermo Fisher, the company offers one of the largest and most up-to-date
selections of FDA-cleared antimicrobials for susceptibility testing (AST). The product line
includes the Thermo Scientific Sensititre Systems that provide manual and automated
minimum inhibitory concentration (MIC) results and a large, up-to-date selection of
antimicrobials. The complete automated system includes the Sensititre ARIS 2X,
OptiRead, Sensititre AIM, Sensititre Vizion System, Sensititre SWIN computer, barcode
printer and barcode labels.
Thermo Fisher announced the platform has seen strong adoption since its introduction.
Siemens Healthineers and Thermo Fisher announced a strategic agreement focused on
incorporating the QuantStudio 5 System into Siemens' Atellica MDX 160 Molecular
System to provide more flexibility and customization to its laboratory workflow. In
addition, Seegene Inc. and Thermo Fisher jointly announced a collaborative partnership to
seek FDA clearance for Seegene's Allplex diagnostic assay portfolio on the QuantStudio 5
System, for which Thermo Fisher is seeking clearance in parallel.
Molecular Test Business
A major part of the company’s molecular business is based on Thermo Fisher’s diagnostic
platforms for genetic analysis that include the Ion Torrent line, Applied Biosystems 3500
Dx Series genetic analyzers and the Applied Biosystems QuantStudio Dx real-time PCR
instrument.
Affymetrix microarray technologies have been a key enabler for multiplex and
simultaneous analysis of biological systems at the cell, protein, and gene level, facilitating
the rapid translation of benchtop research into clinical and routine use. More than 2,300
microarray systems have been shipped around the world and more than 94,000 peer-
reviewed papers have been published citing Affymetrix technologies.

Siemens Healthineers and Thermo Fisher Scientific announced collaboration that includes
the integration of Thermo Fisher Scientific’s real-time PCR system into Siemens’
VERSANT kPCR Molecular Solution. According to both the companies, bringing a new
level of innovation to the market by providing more flexibility and customization to the
molecular laboratory workflow.
Siemens' Versant kPCR system comprises two components including Siemens' benchtop
sample prep module and an Agilent thermal cycler. Siemens intends to replace the Agilent
thermal cycler with Thermo Fisher's QuantStudio 5, a qPCR platform.
The companies aim to establish themselves in the small to mid-sized hospital and reference
laboratories with a flexible, state-of-the-art system that offers the flexibility to run lab-
developed tests and CE marked or FDA-cleared assays with a moderate degree of
multiplexing. They plan to expand the test menu.
In March 2021, Thermo Fisher completed its FDA listing for the Applied Biosystems
QuantStudio 5 Dx Real-Time PCR System. The high-performing qPCR system's
simplified, efficient workflow minimizes steps to deliver quality results in as little as 30
minutes. The system has high sensitivity and specificity and offers up to six channels for
multiplexing.
Next Generation Sequencing
Next Generation Sequencing (NGS) automation offered by Thermo Fisher is enabled by the
Ion Chef System for library and template prep, and by the Ion S5 Sequencer. Also, Ion
AmpliSeq technology enables NGS results from low-quality, degraded samples and offers
various applications from a single workflow for inherited disease research, cancer research,
and human identification applications.
In September 2019, TFS entered into an agreement with Eli Lilly for the development of a
companion diagnostic using NGS-based Oncomine Dx Target Test to identify NSCLC and
thyroid cancer patients who may be treated with Lilly’s LOXO-292.
In November 2019, TFS launched its Ion Torrent Genexus System, a NGS platform
featuring an automated specimen-to-report workflow that delivers results in a single day.
The company also introduced its Oncomine Precision Assay, an innovative pan-cancer

panel for the Genexus platform. It enables comprehensive genomic profiling from formalin-
fixed, paraffin-embedded (FFPE) tissue and liquid biopsy samples with a single assay.
In August 2022, the FDA approved the first NGS-based companion diagnostic for NSCLC
patients with HER2 (ERBB2) activating mutations for treatment with ENHERTU. Thermo
Fisher received approval for Oncomine Dx Target Test as a companion diagnostic for
patients with unresectable or metastatic NSCLC. The test is the only NGS CDx that has
received regulatory approval and is available in 17 countries for 15 targeted therapies,
which was first approved in 2017.
qPCR
In April 2019, Thermo Fisher launched the Applied Biosystems QuantStudio 6 and 7 Pro
Real-Time PCR Systems, the world's first Smart qPCR instruments (according to Thermo
Fisher). Capabilities include facial authentication, voice commands, radio-frequency
identification (RFID)-enabled plate scanning, and quick access to service and support with
a single touch. QuantStudio Pro instruments use RFID-enabled Applied Biosystems
TaqMan Array Plates for seamless upload of plate layout and assay information for setting
up the run. This eliminates manual data entry, reduces potential errors and improves
experimental reproducibility. Results from experiments can then be analyzed remotely from
any desktop computer or smart phone using the Instrument Connect mobile app.
Oncology Companion Diagnostics
The Oncomine Dx Target Test is based on Thermo Fisher's Ion AmpliSeq technology and
runs on its PGM Dx System, which has FDA market clearance for analysis of formalin-
fixed paraffin embedded tissue samples. The technology can gauge multiple genetic
markers from 10 nanograms of DNA, a feature Thermo Fisher highlighted given the
challenge of procuring large biopsy samples from advanced lung cancer patients.
The next-generation sequencing-based test is designed to detect 46 cancer-driver gene

variants associated with approved and investigational targeted therapies for solid tumors —
including ones against EGFR, BRAF, KRAS, and ERBB2 mutations, and ALK, ROS1,
RET, NTRK, and MET fusions. It is also validated as a companion diagnostic for certain
approved non-small cell lung cancer therapies including ALK, ROS1, and BRAF kinase
inhibitors, as well as EGFR exon 19 deletions and L858R tyrosine kinase inhibitors.

In June 2020, the company made an agreement with Agios Pharmaceuticals to co-develop a
CDx for low grade glioma. The companies collaborate on validating biomarkers for a test
that will be based on Thermo Fisher’s Oncomine Precision Assay and used to identify
variant positive patients. Additionally, in June, FDA granted Breakthrough Device
Designation for Oncomine Precision Assay to identify IDH1 and IDH2 mutations in low
grade glioma patients.
In June 2020, Thermo Fisher expanded its partnership with Daiichi Sankyo to co-develop a
CDx that will use NGS-based Oncomine Dx Target Test. The CDx is designed to identify
NSCLC patients with HER2 mutations who may be eligible for Enhertu.
In August 2020, the company signed a CDx agreement with Hengrui Therapeutics to
develop a CDx that uses the Oncomine Precision Assay to identify NSCLC patients who
may be eligible for pryotinib.
In September 2020, the company received FDA approval of the company’s Oncomine Dx
Target Test as a CDx to identify RET fusion-positive, metastatic NSCLC in patients who
are candidates for Gavreto. This is the first and only FDA-approved test for a targeted
treatment for RET fusion -positive NSCLC.
Mass Spectrometry
Thermo Fisher claims to be the market leader in mass spectrometry, and while the
instruments have historically been research-use only tools, the company is working to
advance its mass spec offerings in clinical diagnostics.
In May 2020, the company showcased its new Orbitrap Exploris 240 mass spectrometer
which expands the Orbitrap Exploris platform and is designed to give scientists working in
proteomics, metabolomics, biopharmaceutical characterization and small-molecules, the
analytical performance required for research and high-throughput analyses. The new
system advances discovery and identification with increased accuracy for confident scale-
up, while providing operational simplicity and streamlining time-to-result.
COVID-19
In March 2020, the company received FDA EUA authorization for its SARS-CoV-2
diagnostic test. The authorized test uses Applied Biosystems TaqPath Assay technology

and is designed to provide patient results within four hours of a sample being received by a
lab. The estimated time-to-result also includes time for sample preparation and instrument
analysis.
In May 2020, the FDA expanded TFS’s authorization for its multiplex RT-PCR test
intended for the qualitative detection of nucleic acid from SARS-CoV-2. In addition to the
previously approved Applied Biosystems 7500 Real-time PCR series and a version of the
Applied Biosystems QuantStudio 5, labs can now run tests on specific configurations of
QuantStudio 7 Flex and QuantStudio 5 Real‑time PCR instruments, contributing
significantly to the number of instruments available for testing.
Additionally, in May 2020, the company released the OmniPATH COVID-19 Total
Antibody ELISA test that detects IGM and IgG. The test is designed to run on an open
instrument platform, and the determination of antibody status aids in the diagnosis of the
disease during the acute and recovery stages of infection. In December 2020, Thermo
Fisher secured CE marking for its OmniPATH Combi SARS-CoV-2 IgG ELISA Test.
In October 2020, Thermo Fisher introduced two new SARS-CoV-2 antibody tests – the
OmniPATH COVID-19 Total Antibody ELISA Test and the ELiA SARS-CoV-2 Sp1 IgG
Test. he OmniPATH COVID-19 Total Antibody ELISA test, developed in conjunction with
the Mayo Clinic and WuXi Diagnostics as previously announced, has been granted
Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA)
for qualitative detection of total antibodies to SARS-CoV-2, including immunoglobulin M
(IgM), immunoglobulin A (IgA) and immunoglobulin G (IgG).
In March 2021, the company launched its Applied Biosystems TaqMan SARS-CoV-2
Mutation Panel, which is a customizable menu of 22 PCR assays for identification of
SARS-CoV-2 mutations. Additionally, in March 2021, the company launched the Applied
Biosystems QuantStudio 5 Dx RtPCR.
In June 2021, Thermo Fisher launched the Ion AmpliSeq SARS-CoV-2 Insight Research
Assay to improve SARS-CoV-2 surveillance. The assay is designed to enable early
identification of variants.
In June 2021, the company launched a new COVID-19 test – the TaqPATH COVID-19
Fast PCR Combo Kit 2.0, which expands the menu for detection of active SARS-CoV-2
infections.

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United States Market for In

Vitro Diagnostic Tests, 4th

CHAPTER 1: EXECUTIVE SUMMARY............................................................................................................ 1

U.S. IVD MARKET .............................................................................................................................................. 1

CHAPTER 2: INTRODUCTION TO U.S. HEALTH CARE .................................................................................... 9

THE UNITED STATES AND IN VITRO DIAGNOSTICS...................................................................................................... 9

October 2022 © Kalorama Information i

Legionellosis, Listeriosis, Lyme Disease, Malaria, Meningococcal Disease, Pertussis, Q Fever,

CHAPTER 3: U.S. IVD MARKET ANALYSIS .................................................................................................. 41

CLINICAL CHEMISTRY ......................................................................................................................................... 42

ii October 2022 © Kalorama Information

Figure 3-3: U.S. Molecular Microbiology / Virology Market Distribution Estimates by

October 2022 © Kalorama Information iii

CHAPTER 4: TOP TIER U.S. IVD MARKET PLAYERS ..................................................................................... 81

Table 4-1: 2021 U.S. IVD Competitor Revenues ($ millions) .................................................................... 81

iv October 2022 © Kalorama Information

Recent Revenue History ........................................................................................................................ 104

October 2022 © Kalorama Information v

DANAHER CORPORATION ................................................................................................................................. 131

vi October 2022 © Kalorama Information

October 2022 © Kalorama Information vii

Recent Revenue History ........................................................................................................................ 193

viii October 2022 © Kalorama Information

October 2022 © Kalorama Information ix

Chapter 1: Executive Summary

Chapter 1: Executive Summary

U.S. IVD Market

October 2022 © Kalorama Information 1

Chapter 1: Executive Summary

2 October 2022 © Kalorama Information

Chapter 1: Executive Summary

Segment 2022 2027 CAGR

Clinical Chemistry $3,481 $3,671 1.1%

Microbiology - ID/AST 1,775 $2,089 3.3%

POC Diabetes (all) $8,617 $11,502 5.9%

POC - Other $11,996 $11,210 -1.3%

Immunoassay $12,891 $14,225 2.0%

Coagulation $1,068 $1,266 3.5%

Histology $1,822 $2,254 6.2%

Hematology $1,895 $2,242 3.4%

Blood Typing $507 $539 1.3%

Others $74 $81 1.8%

Total $54,033 $59,154 1.8%

Source: Kalorama Information

October 2022 © Kalorama Information 3

Chapter 1: Executive Summary

Source: Kalorama Information

4 October 2022 © Kalorama Information

Chapter 1: Executive Summary

Top 12 U.S. IVD Market Participants and Rankings

October 2022 © Kalorama Information 5

Chapter 1: Executive Summary

Company Rank IVD Strengths

Core Lab Integrated Chemistry, Diabetes Self-Testing, Point-of-Care

Core Lab Integrated Chemistry, Molecular Diagnostics, Diabetes Self-

Core Lab Integrated Chemistry, Coagulation, Urinalysis, Hematology,

Thermo Fisher Scientific 5 Immunoassays, Microbiology, Molecular Diagnostics, Histology

Hologic 7 Histology, Molecular Diagnostics, Blood Banking

Illumina 8 Sequencing, microarray

bioMérieux 10 Microbiology, Immunoassays, Molecular Diagnostics

Exact Sciences 11 Molecular genome cancer diagnostic testing

Ortho Clinical 12 Core Lab Integrated Chemistry, Blood Banking

Source: Kalorama Information

6 October 2022 © Kalorama Information