POC Diagnostics - Future Players and Prospects

POC Diagnostics:
Players, products & future

market prospects
World Leaders in Health Industry Analysis

POC Diagnostics: Players, products & future market prospects
November 2009
ISBN: 978 1 85822 359 9
© Copyright 2009 Espicom Business Intelligence
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ii ©Espicom Business Intelligence November 2009

POC Diagnostics: Players, products & future market prospects Table of Contents
Contents
EXECUTIVE SUMMARY................................................................................................................................... 1
BACKGROUND............................................................................................................................................................................ 1
The Role Of POC Testing.........................................................................................................................................................2
CURRENT MARKET DYNAMICS................................................................................................................................................ 4
Fig.1: POC Diagnostics in Relation to the IVD Market, 2008....................................................................................................................................................................4
Fig.2: Percentage of POC Diagnostics Market by Product, 2008.............................................................................................................................................................5
Fig.3: POC Diagnostics Market by Product, excl. Glucose, 2008..............................................................................................................................................................6
Customers of POC Diagnostic Products................................................................................................................................6
POC Technologies by Customer Segment................................................................................................................................................................................................7
Fig.4: POC Diagnostics Market by Customer Type, 2008.........................................................................................................................................................................8
Fig.5: POC Diagnostics Self-Testing Market by Product Type, 2008........................................................................................................................................................8
Regional Perspective.............................................................................................................................................................8
Fig.6: POC Diagnostics Market by Region, 2008...................................................................................................................................................................................10
Fig.7: Professional POC Diagnostics Market by Region, 2008...............................................................................................................................................................10
Regulatory and Reimbursement Environment.................................................................................................................10
CLIA Waiver.........................................................................................................................................................................................11
COMPETITIVE LANDSCAPE..................................................................................................................................................... 12
Market Leaders by POC Product Type....................................................................................................................................................................................................12
Key POC Diagnostics Acquisitions, 2008-2009......................................................................................................................................................................................13
GROWTH DRIVERS, RESTRAINTS AND FUTURE OPPORTUNITIES.................................................................................... 14
POC Diagnostics as a Disruptive Technology.....................................................................................................................15
Clinical Utility and Accuracy................................................................................................................................................15
Connectivity..........................................................................................................................................................................16
Future Technology: Next-Generation POC Diagnostic Products.....................................................................................17
Summary: Market Drivers, Restraints and Opportunities....................................................................................................................................................................18
MARKET OUTLOOK.................................................................................................................................................................. 18
Global POC Diagnostics Market by Product Type, 2007-2014 (US$ million).........................................................................................................................................19
POC Diagnostics Market by Product Growth, 2008-2014 (%)..............................................................................................................................................................19
Fig:8: Percentage of POC Diagnostics Market by Product, 2014E..........................................................................................................................................................20
Fig.9: POC Diagnostics Market by Product, excl. Glucose, 2014E...........................................................................................................................................................20
POC PRODUCTS AND TECHNOLOGIES........................................................................................................ 21
POC BLOOD GLUCOSE TESTING AND DIABETES................................................................................................................. 21
WHO Diabetes Prevalence, 2000 and 2030..........................................................................................................................................................................................22
Blood Glucose Testing Market Dynamics.......................................................................................................................... 22
Leading Companies’ Diabetes Care Sales, 2004-2008 (US$ million)....................................................................................................................................................22
Fig.10: Global Blood Glucose Testing Market, 2005-2014E (US$ million).............................................................................................................................................23
Fig.11: Blood Glucose Testing Market by Customer Type, 2008.............................................................................................................................................................23
Diabetes Self-Testing.......................................................................................................................................................... 23
Conventional Blood Glucose Testing Products and Technologies.................................................................................. 25
FDA Warning - GDH-PQQ Test Strips.............................................................................................................................................25
Market-Leading Self-Testing Blood Glucose Meters.............................................................................................................................................................................27
Competing Self-Testing Blood Glucose Meters......................................................................................................................................................................................28
New Products ....................................................................................................................................................................................28
Abbott’s FreeStyle Lite and FreeStyle Freedom Lite . ...............................................................................................................................................................28
Arkray’s Glucocard Blood Glucose Monitoring Systems............................................................................................................................................................29
AgaMatrix’ WaveSense Products...............................................................................................................................................................................................29
Bayer’s Contour USB....................................................................................................................................................................................................................29
Bayer’s DIDGET Meter.................................................................................................................................................................................................................30
Home Diagnostics.......................................................................................................................................................................................................................30
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Table of Contents POC Diagnostics: Players, products & future market prospects
Infopia’s Evolution.......................................................................................................................................................................................................................31
LifeScan’s New OneTouch Products............................................................................................................................................................................................31
Roche’s New Accu-Chek Products .............................................................................................................................................................................................32
Standard Diagnostics’ SD Codefree ...........................................................................................................................................................................................33
Professional Use Products ..............................................................................................................................................................33
Abbott’s Precision PCx ...............................................................................................................................................................................................................33
AgaMatrix’ KeyNote Pro . ...........................................................................................................................................................................................................33
Arkray Assure Blood Glucose Testing Products..........................................................................................................................................................................33
LifeScan’s SureStep Flexx and SureStep Hospital .....................................................................................................................................................................34
Nova Biomedical’s StatStrip Glucose Monitor............................................................................................................................................................................34
Quest Diagnostics’ HemoCue Blood Glucose Testing Systems..................................................................................................................................................34
Roche’s Accu-Chek Inform II ......................................................................................................................................................................................................35
Via Medical’s Via Blood Glucose Monitoring System . ..............................................................................................................................................................35
Continuous Glucose Monitoring.........................................................................................................................................35
Clinical Trial Results - Highlighting Benefits and Drawbacks...................................................................................................36
Reimbursement Issues.....................................................................................................................................................................36
CGM Competitive Landscape..........................................................................................................................................................37
Medtronic’s CGM Systems...............................................................................................................................................................37
Paradigm Veo System.................................................................................................................................................................................................................37
CGMS iPro Recorder....................................................................................................................................................................................................................38
Guardian REAL-Time System......................................................................................................................................................................................................38
Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System..................................................................................................................38
OneTouch UltraLink Meter..........................................................................................................................................................................................................39
Clinical Trials................................................................................................................................................................................................................................39
DexCom’s CGM Systems...................................................................................................................................................................40
Litigation with Abbott................................................................................................................................................................................................................40
Abbott’s FreeStyle Navigator CGM System..................................................................................................................................41
ACON Laboratories On Call Plus ....................................................................................................................................................42
A Menarini Diagnostics’ GlucoDay S..............................................................................................................................................42
CGM Products in Development......................................................................................................................................................42
DexCom Products.......................................................................................................................................................................................................................42
Medtronic....................................................................................................................................................................................................................................43
Next-Generation Blood Glucose Testing .......................................................................................................................... 43
OrSense’s NBM-200G Non-Invasive Blood Glucose Meter........................................................................................................44
Products in Development................................................................................................................................................................44
AiMedics’ HypoMon . .................................................................................................................................................................................................................44
Calisto Medical’s Glucoband.......................................................................................................................................................................................................44
Draper Laboratory’s Ion-Selective Quantum Dots.....................................................................................................................................................................45
Echo Therapeutics’ Symphony tCGM System............................................................................................................................................................................45
Freedom Meditech’s Non-Invasive Technology.........................................................................................................................................................................47
Integrity Applications’ GlucoTrack..............................................................................................................................................................................................47
Lein Applied Diagnostics............................................................................................................................................................................................................48
LighTouch Medical Technology..................................................................................................................................................................................................48
MicroCHIPS..................................................................................................................................................................................................................................48
Oxygen Biotherapeutics/Glucometrics......................................................................................................................................................................................49
Sensors for Medicine & Science’s SMSI Glucose Sensor.............................................................................................................................................................49
Solianis Monitoring’s Non-Invasive Continuous Glucose Monitor............................................................................................................................................49
VeraLight’s SCOUT DS .................................................................................................................................................................................................................50
Other Blood Glucose Products in Development................................................................................................................51
GluMetrics’ GluCath Intravascular CGM........................................................................................................................................51
Luminous Medical’s Automated Blood Glucose Monitor .........................................................................................................52
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HbA1c Testing.......................................................................................................................................................................52
HbA1c Products.................................................................................................................................................................................53
ApexBio’s A1C Express.................................................................................................................................................................................................................53
Arkray’s ADAMS A1c HA-8160.....................................................................................................................................................................................................53
Axis-Shield’s Afinion HbA1c and NycoCard HbA1c Tests............................................................................................................................................................53
Bayer’s A1CNow Products...........................................................................................................................................................................................................53
Bio-Rad’s in2it A1C Analyser ......................................................................................................................................................................................................54
DiaSys Diagnostic Systems’ InnovaStar......................................................................................................................................................................................54
Hubit’s LabonaCare HbA1c . .......................................................................................................................................................................................................54
Infopia’s Easy/Clover A1c.............................................................................................................................................................................................................54
Inverness Medical Innovations’ Cholestech GDX.......................................................................................................................................................................54
MEC Dynamics’ Avie A1c HbA1c System ....................................................................................................................................................................................54
Quotient Diagnostics’ Quo-Test..................................................................................................................................................................................................55
Siemens’ DCA Vantage Analyser................................................................................................................................................................................................55
TOSOH Bioscience’s G7 and G8 HbA1c Analysers .......................................................................................................................................................................55
In Development..........................................................................................................................................................................................................................55
Ketone Testing..................................................................................................................................................................... 56
POC MULTI-FUNCTIONAL CLINICAL CHEMISTRY ANALYSERS..........................................................................................56
Abaxis’ Piccolo xpress......................................................................................................................................................... 56
Abbott’s i-STAT POC Products.............................................................................................................................................57
Audit Diagnostics’ Liqui-Stat Wet Chemistry POC System.............................................................................................. 58
Arkray’s SpotChem EZ Dry Chemistry Analyser and SpotChem D-Concept.................................................................. 58
Axis-Shield’s Afinion POC System...................................................................................................................................... 58
Axis-Shield’s NycoCard System.......................................................................................................................................... 59
Horiba ABX’ ABX Pentra 400 Clinical Chemistry Analyser............................................................................................... 60
MagnaBioSciences’ MICT.................................................................................................................................................... 60
Ortho-Clinical Diagnostics' VITROS DT60 II Chemistry System....................................................................................... 60
Probe Scientific MicroEye Blood Analysis Device..............................................................................................................61
Radiometer’s AQT90 FLEX Immunoassay Analyser...........................................................................................................61
ReLIA Diagnostic Systems’ ReLIA System.......................................................................................................................... 62
TOSOH Bioscience’s AIA-360 System . ............................................................................................................................... 62
Wako Diagnostics’ APOLOWAKO Point-of-Care Analyzer . ............................................................................................. 62
In Development ................................................................................................................................................................................63
Claros Diagnostics’ Claros System..............................................................................................................................................................................................63
DxTech’s Vantix System...............................................................................................................................................................................................................63
POC CARDIOVASCULAR TESTING..........................................................................................................................................64
POC Coagulation Testing.................................................................................................................................................... 64
Market Dynamics .............................................................................................................................................................................65
Fig.12: Global POC Coagulation Market, 2007-2014E (US$ million)......................................................................................................................................................65
Self-Monitoring.................................................................................................................................................................................66
Inverness Medical Innovations’ HemoSense INRatio System and CoagCare............................................................................................................................66
International Technidyne Corporation’s ProTime Microcoagulation System...........................................................................................................................67
Roche’s CoaguChek XS ...............................................................................................................................................................................................................67
Professional Use Products...............................................................................................................................................................67
Axis-Shield Products...................................................................................................................................................................................................................68
Helena Laboratories’ Cascade POC System................................................................................................................................................................................68
Medtronic‘s ACT Plus Automated Coagulation Timer System..................................................................................................................................................69
Instrumentation Laboratory’s GEM PCL Plus.............................................................................................................................................................................69
International Technidyne Corporation’s Hemochron Whole Blood Coagulation System........................................................................................................69
Roche’s CoaguChek Systems.......................................................................................................................................................................................................70
Cardiac Markers....................................................................................................................................................................70
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POC Testing........................................................................................................................................................................................71
Fig.13: Global POC Cardiac Marker Testing Market, 2007-2014E (US$ million)....................................................................................................................................72
POC Testing Products.......................................................................................................................................................................73
Currently-Available Cardiac Marker POC Tests......................................................................................................................................................................................73
bioMérieux VIDAS Emergency Care Products............................................................................................................................................................................74
DxCon POC Cardiovascular Tests.................................................................................................................................................................................................74
Inverness Medical Innovations’ Triage and Clearview Products...............................................................................................................................................75
Princeton BioMeditech/LifeSign’s StatusFirst Tests and DXpress Reader.................................................................................................................................76
Mitsubishi Chemical’s Pathfast Immunoassay Analyzer...........................................................................................................................................................76
Response Biomedical’s RAMP 200 Platform..............................................................................................................................................................................76
Roche Cardiac Testing Products.................................................................................................................................................................................................77
Siemens’ Stratus CS Analyzer.....................................................................................................................................................................................................77
Cholesterol Testing............................................................................................................................................................. 78
Home Testing.....................................................................................................................................................................................78
Chematics Chemcard Cholesterol Test.......................................................................................................................................................................................78
Infopia’s Lipid Pro........................................................................................................................................................................................................................79
Inverness Medical Innovations’ First Check Cholesterol Test....................................................................................................................................................79
Roche’s Accutrend Plus ..............................................................................................................................................................................................................79
Syntron Bioresearch’s Venture Total Cholesterol Test ..............................................................................................................................................................79
In Development . ........................................................................................................................................................................................................................79
Professional Use Products...............................................................................................................................................................79
Inverness Medical Innovations’ Cholestech LDX System ..........................................................................................................................................................80
Polymer Technology Systems’ CardioChek................................................................................................................................................................................80
PreMD’s PREVU Point of Care Skin Sterol Test............................................................................................................................................................................80
POC HAEMATOLOGY AND HAEMOSTASIS PRODUCTS......................................................................................................82
Haematology Analysers...................................................................................................................................................... 82
Beckman Coulter’s COULTER AC•T Series .....................................................................................................................................82
Chempaq’s POC Haematology Analysers.....................................................................................................................................82
Quest Diagnostics’ HemoCue White Blood Cell Analyzer.........................................................................................................83
Horiba ABX’ Haematology Analysers............................................................................................................................................83
ABX Micros ES60.........................................................................................................................................................................................................................83
ABX Micros 60.............................................................................................................................................................................................................................83
ABX Micros CRP 200....................................................................................................................................................................................................................84
ABX Pentra 60C+ . ......................................................................................................................................................................................................................84
Symex’ Haematology Analysers.....................................................................................................................................................84
Arkray’s PocketChem BA Blood Ammonia Meters........................................................................................................... 84
Arkray’s Lactate Pro LT-1710 Blood Lactate Test Meter ................................................................................................... 85
Haemoglobin Systems........................................................................................................................................................ 85
ApexBio’s HemoSmart Haemoglobin Screening System..........................................................................................................85
Audit Diagnostics’ Hb-Stat..............................................................................................................................................................85
International Technidyne’s Hgb Pro Professional Hemoglobin Testing System..................................................................85
Quest Diagnostics’ HemoCue Haemoglobin Systems...............................................................................................................85
HemoCue 201 DM Analyser Whole Blood Systems...................................................................................................................................................................86
Stanbio Laboratory’s HemoPoint H2 and STAT-Site M Hgb .....................................................................................................86
URIT Medical’s HemoTest Hemoglobin Meter.............................................................................................................................87
Coagulation, Platelet Function and Haemostasis............................................................................................................ 87
Platelet Function Assessment.........................................................................................................................................................87
Accumetrics’ VerifyNow System................................................................................................................................................................................................87
Akers Biosciences’ PIFA Heparin/PF4 Rapid Assay.....................................................................................................................................................................88
DiaMed’s Impact Analyzer ........................................................................................................................................................................................................89
Haemonetics’ TEG Thrombelastograph Hemostasis Analyzer..................................................................................................................................................89
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Helena Laboratories’ Plateletworks System..............................................................................................................................................................................89

Medtronic’s HMS PLUS Haemostasis Management System.....................................................................................................................................................89
Pentapharm’s ROTEM Systems...................................................................................................................................................................................................89
Siemens’ PFA-100 Platelet Function Analyser...........................................................................................................................................................................90
Sienco’s Sonoclot Coagulation & Platelet Function Analyzers..................................................................................................................................................90
POC BLOOD GAS/ELECTROLYTE ANALYSERS...................................................................................................................... 91
Mayo Clinic’s Estimated Glomerular Filtration Rate Study..............................................................................................91
Arkray’s SpotChem EL Electrolyte Analyser.......................................................................................................................92
Epocal’s epoc.........................................................................................................................................................................92
Instrumentation Laboratory’s POC Critical Care Diagnostics..........................................................................................92
Synthesis Blood Gas Analysers.......................................................................................................................................................93
International Technidyne’s IRMA TRUpoint Blood Analysis System.............................................................................. 93
International Technidyne Corporation’s AVOXimeter Products..................................................................................... 93
Nova Biomedical’s Products............................................................................................................................................... 94
Statsensor Creatinine Meter...........................................................................................................................................................94
Stat Profile Critical Care Xpress ......................................................................................................................................................94
Stat Profile pHOx ........................................................................................................................................................................................................................95
Nova Biomedical Electrolyte/Chemistry Analysers....................................................................................................................95
Patient Data Manager (PDM)..........................................................................................................................................................95
OPTI Medical Systems’ Products........................................................................................................................................ 96
OrSense’s NBM-200MP Multi-Parameter Sensor............................................................................................................. 96
Clinical Trial Results ....................................................................................................................................................................................................................97
Radiometer’s Blood Gas Analysers.................................................................................................................................... 97
1st automatic.....................................................................................................................................................................................97
ABL80 FLEX.........................................................................................................................................................................................98
ABL800 FLEX......................................................................................................................................................................................98
ABL77...................................................................................................................................................................................................98
ABL5.....................................................................................................................................................................................................98
NPT7....................................................................................................................................................................................................98
Roche’s cobas Blood Gas Analysers................................................................................................................................... 98
Siemens’ Blood Gas Analyser Range.............................................................................................................................................99
RAPIDPoint 340/350 Blood Gas Systems......................................................................................................................................99
RAPIDPoint 400 Series.....................................................................................................................................................................99
RapidComm.......................................................................................................................................................................................99
Via Medical’s Products.................................................................................................................................................................. 100
POC INFECTIOUS DISEASE TESTS........................................................................................................................................100
Fig.14: Global POC Infectious Disease Testing Market, 2007-2014E (US$ million)..............................................................................................................................101
POC Influenza Testing........................................................................................................................................................101
Performance and Use of Rapid Influenza Tests in the US........................................................................................................102
Flu Detection Products...................................................................................................................................................................103
3M Rapid Detection Flu A+B Test/RAMP Influenza A/B Assay..............................................................................................................................................103
Arkray’s SPOTCHEM IL SL-4720 ................................................................................................................................................................................................103
Becton Dickinson’s Directigen EZ Flu A+B test........................................................................................................................................................................104
Genzyme Diagnostics’ OSOM Influenza A & B Test..................................................................................................................................................................104
Inverness Medical Innovations’ BinaxNOW Influenza A&B Test.............................................................................................................................................104
Inverness Medical Innovations’ Clearview Exact Influenza A & B...........................................................................................................................................104
Medix Biochemica’s Actim Influenza A&B...............................................................................................................................................................................104
Meridian Bioscience’s TRU FLU.................................................................................................................................................................................................105
Quidel’s QuickVue Influenza Tests............................................................................................................................................................................................105
Remel’s Xpect Flu A&B..............................................................................................................................................................................................................105
SA Scientific’s SAS FluAlert ......................................................................................................................................................................................................105
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Sysmex’ POCTEM Influenza A/B...............................................................................................................................................................................................105

Products in Development..............................................................................................................................................................106
Chembio’s DPP Influenza .........................................................................................................................................................................................................106
DxCon/HX Diagnostics’ fluID and panfluID Rapid Influenza Test............................................................................................................................................106
GlaxoSmithKline and Enigma Diagnostics ..............................................................................................................................................................................106
Meso Scale Diagnostics’ MSD Point of Care Influenza Test.....................................................................................................................................................107
Sysmex’ Avian Influenza Test...................................................................................................................................................................................................107
Respiratory Syncytial Virus.............................................................................................................................................. 107
3M Rapid Detection RSV Test........................................................................................................................................................108
Group A Streptococcus Tests............................................................................................................................................ 109
Currently Available POC Tests..............................................................................................................................................................................................................109
POC HIV Testing..................................................................................................................................................................110
HIV Prevalence by Region, 2007.......................................................................................................................................................................................................... 111
Market Dynamics............................................................................................................................................................................ 111
Currently-Available Products.......................................................................................................................................................112
Ani Biotech’s Biocard HIV (1+2)................................................................................................................................................................................................ 112
AT First Diagnostic’s FirstVue HIV Tests.................................................................................................................................................................................... 112
bioLytical Laboratories’ INSTI Kit.............................................................................................................................................................................................. 112
BioMérieux’ VIKIA HIV1/2 HIV Test........................................................................................................................................................................................... 113
Bio-Rad’s Multispot HIV-1/HIV-2 Rapid Test............................................................................................................................................................................ 113
Calypte Biomedical’s Aware HIV-1/2 Tests............................................................................................................................................................................... 113
Chembio Diagnostics SURE CHECK HIV 1/2/Clearview Complete HIV 1/2.............................................................................................................................. 114
EY Laboratories’ InstantCHEK................................................................................................................................................................................................... 115
Hema Diagnostic Systems........................................................................................................................................................................................................ 115
IND Diagnostic’s One-Step Anti-HIV (1+2) Tests...................................................................................................................................................................... 115
Inverness Medical Innovations’ Determine and Clearview..................................................................................................................................................... 115
MedMira’s Tests........................................................................................................................................................................................................................ 116
OraSure’s OraQuick ADVANCE HIV-1/2 ..................................................................................................................................................................................... 116
Trinity Biotech’s POC HIV Tests.................................................................................................................................................................................................. 117
Savyon Diagnostics’ HIVSav 1/2/0 Rapid SeroTest.................................................................................................................................................................. 118
Standard Diagnostics’ SD BIOLINE HIV-1/2 3.0......................................................................................................................................................................... 118
Calypte Biomedical................................................................................................................................................................................................................... 118
Chembio’s DPP HIV 1/2 Screening Assay.................................................................................................................................................................................. 119
OraSure’s OraQuick HIV OTC Test . ............................................................................................................................................................................................ 119
Inverness Medical Innovations’ pima Point-of-Care CD4 Instrument ................................................................................................................................... 119
Inverness Medical Innovations’ Clondiag HIV Molecular Device.............................................................................................................................................120
POC Hepatitis Tests............................................................................................................................................................120
Hepatitis B . ......................................................................................................................................................................................120
Hepatitis C........................................................................................................................................................................................121
Available Tests.................................................................................................................................................................................121
Alfa Scientific Designs’ Instant-View Tests..............................................................................................................................................................................121
AT First Diagnostic FirstVue Rapid Test Kit ..............................................................................................................................................................................121
BioMérieux‘ VIKIA HBs Ag Hepatitis B Test..............................................................................................................................................................................122
MedMira’s MiraWell Rapid HBV and HCV Tests.......................................................................................................................................................................122
Runbio Biotech’s One Step Tests...............................................................................................................................................................................................123
YD Diagnostics’ HepaScan Tests ..............................................................................................................................................................................................123
In Development...............................................................................................................................................................................123
OraSure Technologies’ OraQuick HCV Test ..............................................................................................................................................................................123
MedMira’s Multiplo Combination HIV/Hepatitis Tests...................................................................................................124
H. pylori Tests......................................................................................................................................................................124
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Currently Available H. pylori Tests.......................................................................................................................................................................................................125

Exalenz Bioscience’s BreathID System........................................................................................................................................125
Meretek Diagnostics’ BreathTek UBT..........................................................................................................................................126
Mononucleosis Tests..........................................................................................................................................................126
Currently Available POC Tests..............................................................................................................................................................................................................126
Hema Diagnostic Systems’ Rapid 1-2-3 Hema TB Test....................................................................................................127
Tropical Disease Tests........................................................................................................................................................127
Akers Bioscience..............................................................................................................................................................................127
Ani Biotech’s BIOCARD Malaria....................................................................................................................................................127
Hema Diagnostic Systems’ Malaria Tests...................................................................................................................................127
Quest Diagnostics’ Focus Dengue Rapid Tests..........................................................................................................................127
New Horizons Diagnostic’s Cholera SMART...............................................................................................................................128
Sexually-Transmitted Diseases and Related Diagnostics...............................................................................................128
Ani Biotech’s Biocard Candida and Trichomonas Tests...........................................................................................................128
AT First Diagnostic’s inSTIcheck...................................................................................................................................................128
Focus Diagnostics’ HerpeSelect Express HSV-2.........................................................................................................................129
Genzyme’s OSOM Trichomonas and OSOM BVBLUE Test........................................................................................................129
Gryphus Diagnostics’ BVBLUE......................................................................................................................................................129
Hema Diagnostic Systems’ Rapid 1-2-3 Hema Syphilis............................................................................................................130
MagnaBioSciences MICT Chlamydia Test...................................................................................................................................130
Quidel Reproductive and Women’s Health................................................................................................................................130
Runbio Biotech’s Tests....................................................................................................................................................................130
Savyon Diagnostics’ SavvyCheck.................................................................................................................................................130
Rotavirus and Adenoviral Enteritis Tests.........................................................................................................................131
Ani Biotech’s Biocard Tests............................................................................................................................................................131
Meridian Bioscience ImmunoCard STAT! Rotavirus..................................................................................................................131
Orion Diagnostica’s Diarlex, Rotalex and Adenolex Tests.......................................................................................................131
Trinity Biotech’s Uni-Gold Legionella Urinary Antigen . ................................................................................................131
Ani Biotech’s MySet............................................................................................................................................................131
Products in Development .................................................................................................................................................132
Chembio Diagnostics’ DPP Platform ..........................................................................................................................................132
DPP Syphilis Screen & Confirm.................................................................................................................................................................................................132
DPP Hepatitis C and DPP Hepatitis C/HIV Oral Fluid Antibody Tests ......................................................................................................................................133
DPP Leptospirosis .....................................................................................................................................................................................................................133
Visceral Leishmaniasis Disease Research Institute..................................................................................................................................................................133
Work with Oswaldo Cruz Foundation .....................................................................................................................................................................................134
MedMira ...........................................................................................................................................................................................134
Tyrian Diagnostics’ DiagnostIQ for TB.........................................................................................................................................134
POC C-REACTIVE PROTEIN DIAGNOSTICS.......................................................................................................................... 135
Abaxis’ MetLyte Plus CRP...................................................................................................................................................136
Arkray’s SPOTCHEM IL SL-4720 ........................................................................................................................................136
Axis-Shield..........................................................................................................................................................................136
LifeAssays’ CRP and hsCR...................................................................................................................................................137
Medix Biochemica’s Actim CRP.........................................................................................................................................137
Orion Diagnostica’s QuikRead System.............................................................................................................................137
POC CANCER DIAGNOSTICS................................................................................................................................................. 137
Fig.15: Global POC Cancer Testing Market, 2007-2014E (US$ million)................................................................................................................................................138
Prostate Specific Antigen Tests.........................................................................................................................................138
Market Dynamics............................................................................................................................................................................139
Mediwatch’s PSAwatch............................................................................................................................................................................................................140
Recall of PSA POC Tests ............................................................................................................................................................................................................140
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Occult Blood Testing......................................................................................................................................................... 140

Aerscher Diagnostics’ HemaPrompt ..........................................................................................................................................141
Beckman Coulter’s Hemoccult Tests . .........................................................................................................................................141
Biomerica’s EZ Detect.....................................................................................................................................................................141
Helena Laboratories’ ColoCare.....................................................................................................................................................141
Immunostics’ Hema-Screen..........................................................................................................................................................142
Inverness Medical Innovations’ Tests..........................................................................................................................................142
Orion Diagnostica’s QuikRead System........................................................................................................................................142
Quest Diagnostics’ InSure Quik F I T............................................................................................................................................142
Quidel’s QuickVue iFOB . ...............................................................................................................................................................143
Other Available FOB Tests . ...........................................................................................................................................................144
Gastric Occult Blood Tests.............................................................................................................................................................144
CEA Testing..........................................................................................................................................................................145
Alpha Fetoprotein Testing.................................................................................................................................................145
Bladder Cancer Testing......................................................................................................................................................145
Inverness Medical Innovations’ Matritech NMP22 BladderChek Test..................................................................................146
Mediwatch’s Bladderwatch BTA Test...........................................................................................................................................146
Novel Products in Development...................................................................................................................................... 146
Akers Biosciences’ Breath PulmoHealth Check.........................................................................................................................146
Balter Medical’s Optical Transfer Diagnosis Platform .............................................................................................................146
Guided Therapeutics’ LightTouch Cervical Cancer Detection Device...................................................................................147
Lung and Oesophageal Cancer.................................................................................................................................................................................................148
MASCOT Project’s Lab-on-a-Chip for Breast Cancer Detection.............................................................................................148
POC URINALYSIS.....................................................................................................................................................................149
Fig.16: Global POC Urinalysis Market, 2007-2014E (US$ million).......................................................................................................................................................150
Currently-Available Urine Analysis Test Strips....................................................................................................................................................................................150
Key Products.......................................................................................................................................................................151
ACON Laboratories’ Mission Products........................................................................................................................................151
Arkray’s Products............................................................................................................................................................................151
PocketChem UA.........................................................................................................................................................................................................................151
AUTION ELEVEN.........................................................................................................................................................................................................................151
DiaScreen 50 Urine Chemistry Analyser and DiaScreen Reagent Strips for Urinalysis...........................................................................................................151
Roche’s Products.............................................................................................................................................................................152
Urisys 1100 Urine Analyser.......................................................................................................................................................................................................152
Chemstrip Criterion II Analyzer................................................................................................................................................................................................152
Siemens’ Products...........................................................................................................................................................................152
Clinitek Advantus Analyzer.......................................................................................................................................................................................................152
Clinitek Status Analyser............................................................................................................................................................................................................152
Multistix10 SG Reagent Strips .................................................................................................................................................................................................152
Urinary Tract Infection Tests.............................................................................................................................................153
ACON Laboratories’ Mission UTI Urinary Tract Infection Test Strips.....................................................................................153
Jant Pharmacal’s Accutest Uriscreen Rapid UTI Screen Test ..................................................................................................153
Orion Diagnostica’s Uricult Dipslide Tests..................................................................................................................................153
Microalbumin Testing........................................................................................................................................................153
Axis-Shield’s Afinion ACR Test......................................................................................................................................................154
Biomerica’s Fortel Urine Albumin Test........................................................................................................................................154
Genzyme’s OSOM ImmunoDip Urinary Albumin Test.............................................................................................................154
Orion Diagnostica’s QuikRead U-ALB..........................................................................................................................................154
Quest Diagnostics’ HemoCue Albumin 201 System.................................................................................................................154
Siemens’ Clinitek Microalbumin Strips.......................................................................................................................................155
POC FERTILITY AND PREGNANCY TESTING....................................................................................................................... 155
©Espicom Business Intelligence November 2009

Fig.17: Global POC Pregnancy & Fertility Market, 2007-2014E (US$ million).....................................................................................................................................155
Competitive Landscape - Pregnancy Testing Kits...........................................................................................................156
Inverness Medical’s US Federal Trade Commission Settlement Agreement.......................................................................157
Competitive Landscape - Ovulation Testing Kits........................................................................................................... 158
Competitive Landscape - Menopause Testing Kits........................................................................................................ 158
SPD Swiss Precision Diagnostics’ Consumer Products ...................................................................................................159
Labour and Delivery Testing............................................................................................................................................ 160
Amnisure International’s AmniSure PROM Tests......................................................................................................................160
Medix Biochemica’s Actim PROM and Actim Partus................................................................................................................161
POC DRUGS OF ABUSE TESTING.......................................................................................................................................... 161
Market Dynamics............................................................................................................................................................... 162
Currently-Available POC Drugs of Abuse Testing Products.................................................................................................................................................................162
DoA Product Highlights.................................................................................................................................................................163
Alfa Scientific Designs’ Drug Screen Tests................................................................................................................................................................................163
American Bio Medica’s Drug Abuse Tests................................................................................................................................................................................164
Inverness Medical Innovations’ Tests.......................................................................................................................................................................................165
Phamatech Drugs of Abuse Tests.............................................................................................................................................................................................166
Concateno and Philips Alliance................................................................................................................................................................................................166
Alcohol Testing................................................................................................................................................................................167
ACON Laboratories' Alcohol Testing Products.........................................................................................................................................................................167
Akers Biosciences’ BreathScan.................................................................................................................................................................................................167
Chematics’ Alco-Screen............................................................................................................................................................................................................167
Inverness Medical Innovations’ Products................................................................................................................................................................................167
OraSure’s Q.E.D. Saliva Alcohol Test..........................................................................................................................................................................................168
OTHER POC PRODUCTS.........................................................................................................................................................168
Thyroid Tests...................................................................................................................................................................... 168
Screening Devices Canada’s ThyroChek.....................................................................................................................................168
Ani Biotech’s Biocard Coeliac Tests.................................................................................................................................. 168
BioMérieux’ VIDAS B·R·A·H·M·S PCT Test........................................................................................................................ 169
Exalenz Bioscience’s BreathID System............................................................................................................................ 169
Inverness Medical Innovations’ Triage NGAL Test.......................................................................................................... 169
Magellan Biosciences’ LeadCare II System......................................................................................................................170
EMERGING TECHNOLOGIES................................................................................................................................................. 170
Amic (Johnson & Johnson).................................................................................................................................................171
Atlas Genetics’ Velox..........................................................................................................................................................171
Atonomics’ Atolyzer...........................................................................................................................................................172
Cepheid’s GeneXpert.........................................................................................................................................................172
Draper Laboratory and Sionex .........................................................................................................................................173
Enigma Diagnostics’ PRADA..............................................................................................................................................174
IQuum’s Liat System...........................................................................................................................................................174
MASCOT Project’s Lab-on-a-Chip for Breast Cancer Detection.....................................................................................175
Molecular Vision ................................................................................................................................................................175
MycroLab.............................................................................................................................................................................176
Philips’ Magnotech.............................................................................................................................................................176
T2 Biosystems ....................................................................................................................................................................177
US Naval Research Laboratory’s cBASS............................................................................................................................178
POC MANUFACTURERS.............................................................................................................................. 179
POC COMPANY DIRECTORY.................................................................................................................................................. 179
LEADING COMPANY PROFILES............................................................................................................................................189
Abaxis................................................................................................................................................................................. 189
November 2009 ©Espicom Business Intelligence xi

Piccolo xpress...................................................................................................................................................................................189
Current Alliances.............................................................................................................................................................................190
Distribution Partners................................................................................................................................................................................................................190
bioMérieux SA...........................................................................................................................................................................................................................190
Financial Performance ..................................................................................................................................................................190
Abaxis - Operating Results, 2005-2009 (US$ million)........................................................................................................................................................................191
Latest Results............................................................................................................................................................................................................................191
Abbott.................................................................................................................................................................................192
Diabetes Care...................................................................................................................................................................................192
FreeStyle Blood Glucose Monitoring Products........................................................................................................................................................................192
Precision Xceed (Optium Xceed) Advanced Diabetes Management System..........................................................................................................................193
Precision Xtra Advanced Diabetes Management System.......................................................................................................................................................193
FreeStyle CoPilot Health Management System.......................................................................................................................................................................193
Precision PCx ............................................................................................................................................................................................................................194
QC Manager...............................................................................................................................................................................................................................194
i-STAT Point-of-Care Products.......................................................................................................................................................194
i-STAT System............................................................................................................................................................................................................................194
Cartridges..................................................................................................................................................................................................................................194
Axis-Shield.................................................................................................................................................................................................................................195
Calypte Biomedical...................................................................................................................................................................................................................195
Litigation ..........................................................................................................................................................................................195
Nova Biomedical.......................................................................................................................................................................................................................195
Church & Dwight.......................................................................................................................................................................................................................195
DexCom ....................................................................................................................................................................................................................................196
Becton Dickinson......................................................................................................................................................................................................................196
Financial Performance...................................................................................................................................................................197
Abbott Diagnostics Sales, 2005-2008 (US$ million)...........................................................................................................................................................................197
Fig.18: Percentage of Abbott Diagnostics Revenue by Region, 2008..................................................................................................................................................197
Abbott Diabetes Care Sales by Region, 2005-2008 (US$ million).......................................................................................................................................................198
Fig.19: Percentage of Abbott Diabetes Care Revenue by Region, 2008..............................................................................................................................................198
Latest Results............................................................................................................................................................................................................................198
Accumetrics ....................................................................................................................................................................... 199
Fig.20: Accumetrics Revenue by Segment, 2005-2008 (US$ thousands)...........................................................................................................................................199
VerifyNow System............................................................................................................................................................. 199
Distribution Agreements.................................................................................................................................................. 200
ACON Laboratories............................................................................................................................................................ 201
On Call Plus Blood Glucose Monitoring System .......................................................................................................................201
Mission Urinalysis Products . ........................................................................................................................................................201
Test Strips..................................................................................................................................................................................................................................201
Urine Analysers.........................................................................................................................................................................................................................201
Alcohol Testing................................................................................................................................................................................202
Akers Biosciences . ............................................................................................................................................................ 203
Recent Key Events................................................................................................................................................................................................................................203
Current Products............................................................................................................................................................................ 204
PIFA Heparin/PF4 Rapid Assay.................................................................................................................................................................................................204
BreathScan................................................................................................................................................................................................................................204
Non Core Products....................................................................................................................................................................................................................204
Research and Development......................................................................................................................................................... 204
Tri-Cholesterol Check................................................................................................................................................................................................................204
Breath Ketone Check.................................................................................................................................................................................................................205
xii ©Espicom Business Intelligence November 2009

Breath PulmoHealth Check......................................................................................................................................................................................................205

BreathScan PRO........................................................................................................................................................................................................................205
Current Alliances............................................................................................................................................................................ 206
AFRICA Continental Holdings...................................................................................................................................................................................................206
PULSE Health.............................................................................................................................................................................................................................206
Inverness Medical Innovations.................................................................................................................................................................................................206
Trinity Biotech, Corgenix and Cardinal Health.........................................................................................................................................................................206
Financial Performance.................................................................................................................................................................. 206
Akers Biosciences Operating Results, 2004-2008 (US$ thousands)....................................................................................................................................................207
Latest Results............................................................................................................................................................................................................................207
Fig.21: Akers Biosciences - Revenue by Product, H1 2009...................................................................................................................................................................207
American Bio Medica........................................................................................................................................................ 208
Drug Abuse Tests............................................................................................................................................................................ 208
Urine Tests.................................................................................................................................................................................................................................208
Saliva Tests................................................................................................................................................................................................................................209
Rapid Reader.............................................................................................................................................................................................................................210
Adulteration, Alcohol and Nicotine Products..........................................................................................................................................................................210
Hema Diagnostic Systems........................................................................................................................................................................................................210
American Bio Medical Operating Results, 2004-2008 (US$ millions)................................................................................................................................................211
Latest Results............................................................................................................................................................................................................................ 211
Arkray..................................................................................................................................................................................212
SPOTCHEM IL SL-4720 . ..................................................................................................................................................................212
SpotChem EZ Dry Chemistry Analyser and SpotChem D-Concept.......................................................................................213
SpotChem EL Electrolyte Analyser..............................................................................................................................................213
PocketChem BA Blood Ammonia Meters...................................................................................................................................213
Lactate Pro LT-1710 Blood Lactate Test Meter ..........................................................................................................................214
Urinalysis...........................................................................................................................................................................................214
PocketChem UA.........................................................................................................................................................................................................................214
AUTION ELEVEN.........................................................................................................................................................................................................................214
DiaScreen 50 Urine Chemistry Analyser and DiaScreen Reagent Strips for Urinalysis...........................................................................................................214
Blood Glucose Self-Testing............................................................................................................................................................214
Glucocard Meters .....................................................................................................................................................................................................................214
Assure Blood Glucose Testing Products...................................................................................................................................................................................215
ELITech Group............................................................................................................................................................................................................................215
Nipro..........................................................................................................................................................................................................................................215
MyCareTeam . ...........................................................................................................................................................................................................................216
A Menarini Diagnostics.............................................................................................................................................................................................................216
Axis-Shield..........................................................................................................................................................................217
Afinion POC System........................................................................................................................................................................218
NycoCard . ........................................................................................................................................................................................219
Coagulation Products.....................................................................................................................................................................219
Thrombotrack Coagulometers.................................................................................................................................................................................................219
Thrombotest (PT-INR)...............................................................................................................................................................................................................220
Nycotest PT (INR)......................................................................................................................................................................................................................220
Current Alliances ........................................................................................................................................................................... 220
November 2009 ©Espicom Business Intelligence xiii

Abbott and PSS World Medical................................................................................................................................................................................................220

ITI Techmedia (Biosensor Platform for Theranostic Applications)..........................................................................................................................................220
Fig.22: Axis-Shield Revenue by Business, 2008...................................................................................................................................................................................221
Fig.23: Axis-Shield Revenue by Region, 2008.....................................................................................................................................................................................222
Axis-Shield - POC Segment Operating Results, 2004-2008 (£ million)...............................................................................................................................................222
Axis-Shield - POC Sales by Product Line, 2004-2008 (£ million).........................................................................................................................................................222
Fig.24: Axis-Shield POC Sales by Product, 2008..................................................................................................................................................................................223
Latest Results............................................................................................................................................................................................................................223
Bayer................................................................................................................................................................................... 224
Ascensia Blood Glucose Monitoring Systems............................................................................................................................224
Contour USB..............................................................................................................................................................................................................................225
DIDGET Meter............................................................................................................................................................................................................................225
A1CNow Products........................................................................................................................................................................... 225
Medtronic..................................................................................................................................................................................................................................226
Echo Therapeutics.....................................................................................................................................................................................................................226
Fig.25: Bayer Diabetes Care Revenue, 2005-2008 (EUR million)........................................................................................................................................................227
Bayer Diabetes Care Revenue by Type, 2005-2008 (EUR million).......................................................................................................................................................227
Beckman Coulter............................................................................................................................................................... 228
Rapid Tests....................................................................................................................................................................................... 228
Hemoccult Tests .......................................................................................................................................................................................................................228
Gastroccult ...............................................................................................................................................................................................................................228
Haematology Analysers................................................................................................................................................................ 228
Biomerica........................................................................................................................................................................... 230
Home Diagnostic Products.......................................................................................................................................................... 230
Fortel Urine Albumin Test.........................................................................................................................................................................................................230
Professional Use Products.............................................................................................................................................................231
Biomerica - Operating Results, 2005-2009 (US$ thousand)..............................................................................................................................................................232
Biomerica - Revenue by Region, 2008-2009 (US$ thousand)............................................................................................................................................................232
Fig.26: Percentage of Biomerica’s Revenue by Region, 2009..............................................................................................................................................................233
Latest Results............................................................................................................................................................................................................................233
bioMérieux......................................................................................................................................................................... 234
Emergency Care............................................................................................................................................................................. 234
VIDAS NT-proBNP . ...................................................................................................................................................................................................................234
VIDAS D-Dimer Exclusion..........................................................................................................................................................................................................234
VIDAS Tropinin I Ultra................................................................................................................................................................................................................235
VIDAS B·R·A·H·M·S PCT. Test......................................................................................................................................................................................................235
Rapid Infectious Disease Tests..................................................................................................................................................... 235
VIKIA HIV1/2 HIV Test................................................................................................................................................................................................................235
VIKIA HBs Ag Hepatitis B Test...................................................................................................................................................................................................235
Quidel........................................................................................................................................................................................................................................236
Sysmex . ....................................................................................................................................................................................................................................236
Abaxis........................................................................................................................................................................................................................................236
ReLIA Diagnostic Systems.........................................................................................................................................................................................................236
Roche Diagnostics.....................................................................................................................................................................................................................236
Brahms......................................................................................................................................................................................................................................236
xiv ©Espicom Business Intelligence November 2009

bioMérieux - Operating Results, 2006-2008 (EUR million)................................................................................................................................................................237

Fig.27: Percentage of bioMérieux’ Revenue by Product Type, 2008...................................................................................................................................................237
Fig.28: Percentage of bioMérieux’ Revenue by Region, 2008.............................................................................................................................................................238
Bio-Rad Laboratories........................................................................................................................................................ 239
Point-of-Care HbA1c Testing........................................................................................................................................................ 239
TOX/See Drugs-of-Abuse Testing................................................................................................................................................ 239
Chembio Diagnostics and Inverness Medical Innovations......................................................................................................................................................240
Calypte Biomedical...................................................................................................................................................................................................................240
Calypte Biomedical............................................................................................................................................................241
Aware Rapid Test Product Line.....................................................................................................................................................241
Aware HIV-1/2 OMT (Oral fluid) PRO (Professional).................................................................................................................................................................242
Aware HIV-1/2 Oral OTC............................................................................................................................................................................................................242
Aware HIV-1/2 BSP PRO............................................................................................................................................................................................................242
HIV-1/2 OMT Test Using a Synthetic Antigen...........................................................................................................................................................................242
Aware II (The Ani Platform)......................................................................................................................................................................................................242
Manufacturing Contracts.........................................................................................................................................................................................................243
Calypte Biomedical - Operating Results, 2004-2008 (US$ thousands)..............................................................................................................................................244
Fig.29: Percentage of Calypte’s Revenue by Product, 2008.................................................................................................................................................................245
Latest Results............................................................................................................................................................................................................................245
Chembio Diagnostics........................................................................................................................................................ 246
Rapid HIV Tests............................................................................................................................................................................... 246
Other Tests........................................................................................................................................................................................247
In Development - DPP Platform ..................................................................................................................................................247
DPP HIV 1/2 Screening Assay....................................................................................................................................................................................................248
DPP Syphilis Screen & Confirm.................................................................................................................................................................................................248
DPP Hepatitis C and DPP Hepatitis C/HIV Oral Fluid Antibody Tests ......................................................................................................................................248
DPP Influenza ...........................................................................................................................................................................................................................248
DPP Leptospirosis .....................................................................................................................................................................................................................249
US CDC.......................................................................................................................................................................................................................................250
Infectious Disease Research Institute......................................................................................................................................................................................250
Foundation for Innovative and Novel Diagnostics..................................................................................................................................................................250
Bio-Rad Laboratories................................................................................................................................................................................................................250
Oswaldo Cruz Foundation .......................................................................................................................................................................................................251
Financial Performance...................................................................................................................................................... 251
Chembio - Operating Results, 2004-2008 (US$ thousands)...............................................................................................................................................................252
Chembio - Revenue by Type, 2006-2008 (US$ thousand)..................................................................................................................................................................252
Chembio - Product Sales by Region, 2006-2008 (US$ thousand)......................................................................................................................................................252
Fig.30: Percentage of Chembio’s Revenue by Type, 2008...................................................................................................................................................................253
Fig.31: Percentage of Chembio’s Product Sales by Region, 2008........................................................................................................................................................253
Latest Results............................................................................................................................................................................................................................253
Concateno ......................................................................................................................................................................... 254
Cozart Products.............................................................................................................................................................................. 254
Euromed Products......................................................................................................................................................................... 255
November 2009 ©Espicom Business Intelligence xv

Current Alliances and Contracts.................................................................................................................................................. 255

Philips........................................................................................................................................................................................................................................255
Ireland’s Defence Forces...........................................................................................................................................................................................................255
UK Home Office ........................................................................................................................................................................................................................255
Concateno - Operating Results, 2007-2008 (£ million).......................................................................................................................................................................256
Concateno Revenue by Division, 2007-2008 (£ million).....................................................................................................................................................................256
Fig.32: Percentage of Concateno’s Revenue by Segment, 2008..........................................................................................................................................................257
Concateno Revenue by Industry, 2007-2008 (£ million).....................................................................................................................................................................257
Fig.33: Percentage of Concateno’s Revenue by Industry, 2008...........................................................................................................................................................258
Concateno Revenue by Region, 2007-2008 (£ million).......................................................................................................................................................................258
Fig.34: Percentage of Concateno’s Revenue by Region, 2008.............................................................................................................................................................258
DxCon................................................................................................................................................................................. 259
POC Cardiovascular Tests...............................................................................................................................................................259
Vyent.........................................................................................................................................................................................................................................259
Cardiac STATus and Decision Point...........................................................................................................................................................................................260
In Development - Infectious Disease Tests................................................................................................................................ 260
HX Diagnostics..........................................................................................................................................................................................................................261
Princeton BioMeditech ............................................................................................................................................................................................................261
Genzyme Diagnostics....................................................................................................................................................... 262
Point of Care Tests.......................................................................................................................................................................... 262
OSOM Influenza A & B Test.......................................................................................................................................................................................................262
OSOM Ultra Strep A...................................................................................................................................................................................................................262
OSOM Strep A............................................................................................................................................................................................................................262
OSOM Mono..............................................................................................................................................................................................................................263
OSOM Trichomonas Rapid Test.................................................................................................................................................................................................263
OSOM BVBLUE Test...................................................................................................................................................................................................................263
OSOM ImmunoDip Urinary Albumin Test................................................................................................................................................................................263
OSOM Pregnancy Tests.............................................................................................................................................................................................................263
Home Diagnostics Inc....................................................................................................................................................... 264
TRUEtest Test Strips....................................................................................................................................................................... 264
TRUE2go and TRUEresult.............................................................................................................................................................. 264
TRUEread......................................................................................................................................................................................... 265
TRUEmanager Diabetes Management Software .................................................................................................................... 265
Litigation Settlement - Roche Diagnostics................................................................................................................................ 265
Home Diagnostics - Operating Results, 2004-2008 (US$ million).....................................................................................................................................................267
Home Diagnostics - Revenue by Source, 2006-2008 (US$ million)....................................................................................................................................................267
Fig.35: Percentage of Home Diagnostics’ Revenue by Source, 2008...................................................................................................................................................267
Latest Results and Outlook.......................................................................................................................................................................................................268
Horiba ABX......................................................................................................................................................................... 269
Haematology Analysers................................................................................................................................................................ 269
ABX Micros ES60.......................................................................................................................................................................................................................269
ABX Micros 60...........................................................................................................................................................................................................................269
ABX Micros CRP 200..................................................................................................................................................................................................................269
ABX Pentra 60C+ . ....................................................................................................................................................................................................................270
ABX Pentra 400 Clinical Chemistry Analyser..............................................................................................................................270
Tosoh and Trinity Biotech.........................................................................................................................................................................................................270
Helena Laboratories..................................................................................................................................................................................................................270
xvi ©Espicom Business Intelligence November 2009

Horiba Medical - Operating Results, 2006-2008 (¥ million)..............................................................................................................................................................271
Fig.36: Percentage of Horiba ABX’ Revenue by Region, 2008*...........................................................................................................................................................271
Instrumentation Laboratory............................................................................................................................................ 272
POC Critical Care Diagnostics........................................................................................................................................................272
Synthesis Blood Gas Analysers.................................................................................................................................................................................................273
Purchasing Contracts.....................................................................................................................................................................273
MedAssets Supply Chain Systems............................................................................................................................................................................................273
Premier......................................................................................................................................................................................................................................273
HealthTrust Purchasing Group..................................................................................................................................................................................................273
International Technidyne Corporation . ..........................................................................................................................274
Hemochron Whole Blood Coagulation System.........................................................................................................................274
Hemochron Signature Elite and Hemochron Signature Plus Microcoagulation ...................................................................................................................274
Hemochron Response...............................................................................................................................................................................................................275
IRMA TRUpoint Blood Analysis System.......................................................................................................................................275
AVOXimeter Whole Blood CO Oximeter and Oximeter...........................................................................................................275
ProTime Microcoagulation System..............................................................................................................................................275
Hgb Pro Professional Hemoglobin Testing System..................................................................................................................276
Medical Automation Systems..................................................................................................................................................................................................276
International Technidyne Operating Results, 2004-2008 (US$ million)............................................................................................................................................277
Fig.37: International Technidyne Revenue, 2000-2008 (US$ million)................................................................................................................................................277
Inverness Medical Innovations........................................................................................................................................ 278
POC Professional Diagnostic Products....................................................................................................................................... 280
Cardiology.................................................................................................................................................................................................................................280
Women’s Health........................................................................................................................................................................................................................281
Infectious Diseases....................................................................................................................................................................................................................281
Oncology...................................................................................................................................................................................................................................282
Drugs of Abuse..........................................................................................................................................................................................................................282
Consumer Products....................................................................................................................................................................... 283
First Check Consumer Diagnostics Products............................................................................................................................................................................283
Mergers & Acquisitions................................................................................................................................................................. 283
Genecare, Zycare, Medim and Biosyn......................................................................................................................................................................................283
Concateno . ...............................................................................................................................................................................................................................283
ACON Laboratories’ Rapid Diagnostics Assets.........................................................................................................................................................................283
Vision Biotech and Global Diagnostics CC................................................................................................................................................................................284
Matria Healthcare.....................................................................................................................................................................................................................284
BBI Holdings .............................................................................................................................................................................................................................284
Panbio.......................................................................................................................................................................................................................................284
Earlier Acquisitions....................................................................................................................................................................................................................285
Joint Ventures................................................................................................................................................................................. 286
SPD Swiss Precision Diagnostics...............................................................................................................................................................................................286
Mediwatch................................................................................................................................................................................................................................287
PrognostiX ................................................................................................................................................................................................................................287
Akers Biosciences .....................................................................................................................................................................................................................287
Thermo Fisher Scientific...........................................................................................................................................................................................................287
Chembio....................................................................................................................................................................................................................................288
Trinity Biotech...........................................................................................................................................................................................................................288
November 2009 ©Espicom Business Intelligence xvii

Siemens.....................................................................................................................................................................................................................................288
Litigation.......................................................................................................................................................................................... 288
FTC Settlement..........................................................................................................................................................................................................................288
OraSure Technologies...............................................................................................................................................................................................................289
Beckman Coulter.......................................................................................................................................................................................................................289
Inverness - Operating Results, 2004-2008 (US$ million)....................................................................................................................................................................290
Fig.38: Percentage of Inverness’ Revenue by Segment, 2008.............................................................................................................................................................291
Fig.39: Percentage of Inverness’ Revenue by Region, 2008................................................................................................................................................................291
Inverness Professional Diagnostics Operating Results, 2004-2008 (US$ million)..............................................................................................................................291
Inverness Consumer Diagnostics Operating Results, 2004-2008 (US$ million).................................................................................................................................292
Latest Results............................................................................................................................................................................................................................292
Outlook and Strategy................................................................................................................................................................................................................292
LifeScan.............................................................................................................................................................................. 294
Blood Glucose Monitoring Products.......................................................................................................................................... 294
Consumer Products...................................................................................................................................................................................................................295
Hospital Products......................................................................................................................................................................................................................297
Test Strips..................................................................................................................................................................................................................................298
OneTouch Diabetes Management Software . .......................................................................................................................... 298
DataLink Data Management System......................................................................................................................................... 299
ResMed......................................................................................................................................................................................................................................299
t+ Medical.................................................................................................................................................................................................................................299
Medtronic..................................................................................................................................................................................................................................300
Debiotech..................................................................................................................................................................................................................................300
Telcor.........................................................................................................................................................................................................................................300
Novo Nordisk.............................................................................................................................................................................................................................301
J&J Diabetes Care Revenue, 2004-2008 (US$ million).......................................................................................................................................................................301
Fig.40: LifeScan Sales by Region, 2008...............................................................................................................................................................................................301
Fig.41: LifeScan Sales, 2004-2008 (US$ million).................................................................................................................................................................................302
MedMira ............................................................................................................................................................................ 303
Rapid Tests....................................................................................................................................................................................... 304
Multiplo HIV/HCV......................................................................................................................................................................................................................305
Multiplo HBV/HIV/HCV.............................................................................................................................................................................................................305
HIV Tests....................................................................................................................................................................................................................................305
Hepatitis Tests...........................................................................................................................................................................................................................305
MiraWellhp Test H. pylori Test..................................................................................................................................................................................................306
R&D Activities................................................................................................................................................................................. 306
New Combination Tests............................................................................................................................................................................................................306
Triplex International Biosciences..............................................................................................................................................................................................307
VWR International....................................................................................................................................................................................................................307
US CDC.......................................................................................................................................................................................................................................307
Tri-Star Industries......................................................................................................................................................................................................................307
Vitest . .......................................................................................................................................................................................................................................307
Shenzhen Kang Sheng Bao Bio-Technology............................................................................................................................................................................307
Pan American Health Organization..........................................................................................................................................................................................308
xviii ©Espicom Business Intelligence November 2009

HealthCare Asia MediTech........................................................................................................................................................................................................308

INyDIA Diagnóstico...................................................................................................................................................................................................................308
Voden Medical Instruments ....................................................................................................................................................................................................308
IKXUR.........................................................................................................................................................................................................................................308
MedMira - Operating Results, 2004-2008 (C$ thousands)................................................................................................................................................................309
MedMira - Revenue by Region, 2007-2008 (C$ thousands)...............................................................................................................................................................309
Fig.42: MedMira - Revenue by Region, 2008......................................................................................................................................................................................310
Latest Results............................................................................................................................................................................................................................310
Medtronic............................................................................................................................................................................311
CGM Systems....................................................................................................................................................................................311
Paradigm Veo System...............................................................................................................................................................................................................312
CGMS iPro Recorder..................................................................................................................................................................................................................312
Guardian REAL-Time System....................................................................................................................................................................................................313
Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System................................................................................................................313
OneTouch UltraLink Meter........................................................................................................................................................................................................313
Clinical Trials..............................................................................................................................................................................................................................314
Research and Development.....................................................................................................................................................................................................315
Litigation - Nova Biomedical....................................................................................................................................................................................................315
Alliances - LifeScan and Roche ................................................................................................................................................................................................315
Cardiac Surgery POC Products.....................................................................................................................................................316
ACT Plus Automated Coagulation Timer System.....................................................................................................................................................................316
HMS PLUS Haemostasis Management System........................................................................................................................................................................316
Fig.43: Medtronic Diabetes Revenue, 2005-2009 (US$ million).........................................................................................................................................................317
Fig.44: Medtronic Diabetes Revenue by Region, 2009........................................................................................................................................................................317
Meridian Bioscience...........................................................................................................................................................318
TRU FLU and TRU RSV.....................................................................................................................................................................318
C.difficile Tests.................................................................................................................................................................................318
ImmunoCard STAT! HPSA H. pylori Test......................................................................................................................................319
ImmunoCard STAT! Rotavirus.......................................................................................................................................................319
ImmunoCard STAT! Strep A...........................................................................................................................................................319
Premier......................................................................................................................................................................................................................................319
Immuno Pty Ltd and Scott Pharma . .......................................................................................................................................................................................319
Somagen Diagnostics...............................................................................................................................................................................................................319
Meridian Bioscience - Operating Results, 2004-2008 (US$ million)...................................................................................................................................................321
Meridian Bioscience - Third-Party Sales by Segment, 2004-2008 (US$ million)...............................................................................................................................321
Meridian Bioscience - Operating Income by Segment, 2006-2008 (US$ million)..............................................................................................................................321
Fig.45: Meridian - Revenue by Segment, 2008...................................................................................................................................................................................322
Meridian Bioscience - International Revenue by Source, 2005-2008 (US$ million)...........................................................................................................................322
Fiscal 2009 and 2010 Outlook..................................................................................................................................................................................................322
Nova Biomedical................................................................................................................................................................ 323
StatStrip Hospital Blood Glucose Analysers...............................................................................................................................323
Self-Testing Blood Glucose Analysers.........................................................................................................................................324
Nova Max...................................................................................................................................................................................................................................324
November 2009 ©Espicom Business Intelligence xix

Nova Max Link...........................................................................................................................................................................................................................324

Nova Max Test Strips.................................................................................................................................................................................................................324
Statsensor Creatinine Meter.........................................................................................................................................................324
Whole Blood Stat Testing..............................................................................................................................................................324
Stat Profile Critical Care Xpress ................................................................................................................................................................................................324
Stat Profile pHOx ......................................................................................................................................................................................................................325
Nova Electrolyte/Chemistry Analysers.......................................................................................................................................325
Patient Data Manager (PDM)........................................................................................................................................................326
ACIST Medical Systems.............................................................................................................................................................................................................326
Litigation ..........................................................................................................................................................................................326
Medtronic..................................................................................................................................................................................................................................326
Abbott.......................................................................................................................................................................................................................................327
OraSure Technologies....................................................................................................................................................... 328
OraQuick Rapid Test Platform......................................................................................................................................................328
OraQuick ADVANCE HIV-1/2 .....................................................................................................................................................................................................329
Q.E.D. Saliva Alcohol Test...............................................................................................................................................................329
OraQuick HCV Test ....................................................................................................................................................................................................................329
OraQuick HIV OTC Test ..............................................................................................................................................................................................................330
Premier......................................................................................................................................................................................................................................330
Schering-Plough.......................................................................................................................................................................................................................330
Ortho-Clinical Diagnostics........................................................................................................................................................................................................331
Litigation...........................................................................................................................................................................................331
Inverness Medical Innovations and Church & Dwight............................................................................................................................................................331
OraSure - Operating Results, 2004-2008 (US$ million)......................................................................................................................................................................332
OraSure - OraQuick Sales by Customer Type, 2004-2008 (US$ thousands)........................................................................................................................................333
Fig.46: OraSure - Revenue by Product Line, 2008...............................................................................................................................................................................333
Fig.47: OraQuick Revenue by Customer Type, 2008............................................................................................................................................................................333
Orion Diagnostica.............................................................................................................................................................. 335
QuikRead System............................................................................................................................................................................335
Uricult Dipslide Tests......................................................................................................................................................................335
Rotaviral and Adenoviral Enteritis Tests.....................................................................................................................................336
Orion Diagnostica - Operating Results, 2004-2008 (EUR million)......................................................................................................................................................337
OrSense.............................................................................................................................................................................. 338
NBM-200MP Multi-Parameter Sensor.........................................................................................................................................338
Clinical Trial Results ..................................................................................................................................................................................................................338
NBM-200G........................................................................................................................................................................................339
Phamatech......................................................................................................................................................................... 340
Drugs of Abuse Tests..................................................................................................................................................................... 340
At Home Drug Test....................................................................................................................................................................................................................340
QuickScreen..............................................................................................................................................................................................................................340
QuickScreen Plus.......................................................................................................................................................................................................................340
QuickScreen Cup.......................................................................................................................................................................................................................340
QuickScreen Dipsticks and Cassettes.......................................................................................................................................................................................341
Pregnancy and Fertility Testing...................................................................................................................................................341
xx ©Espicom Business Intelligence November 2009

Quest Diagnostics.............................................................................................................................................................. 342

HemoCue Products........................................................................................................................................................................ 342
Haemoglobin Systems..............................................................................................................................................................................................................343
Blood Glucose Testing...............................................................................................................................................................................................................343
HemoCue Albumin 201 System................................................................................................................................................................................................344
HemoCue White Blood Cell Analyzer.......................................................................................................................................................................................344
Enterix Products............................................................................................................................................................................. 345
InSure Quik F I T Fecal Immunochemical Test..........................................................................................................................................................................345
Focus Diagnostics’ POC Products................................................................................................................................................ 346
HerpeSelect Express HSV-2......................................................................................................................................................................................................346
Focus Dengue Rapid Tests........................................................................................................................................................................................................346
MEC Dynamics ..........................................................................................................................................................................................................................347
Quest Diagnostics - Operating Results, 2004-2008 (US$ million)......................................................................................................................................................348
Quest Diagnostics - Sales and Earnings by Category, 2004-2008 (US$ million)................................................................................................................................348
Fig.48: Quest Diagnostics - Revenue by Division, 2008.......................................................................................................................................................................349
Fig.49: Quest Diagnostics - Revenue by Product Type, 2008..............................................................................................................................................................349
Quidel..................................................................................................................................................................................351
Infectious Disease Tests.................................................................................................................................................................351
QuickVue Influenza Tests..........................................................................................................................................................................................................351
QuickVue Group A Strep Tests..................................................................................................................................................................................................351
QuickVue RSV Test.....................................................................................................................................................................................................................351
Reproductive and Women’s Health.............................................................................................................................................352
QuickVue iFOB ................................................................................................................................................................................352
QuickVue H. Pylori gII Test.............................................................................................................................................................352
bioMerieux................................................................................................................................................................................................................................352
Quidel - Operating Results, 2004-2008 (US$ million)........................................................................................................................................................................353
Quidel - Revenue by Product Type, 2005-2008 (US$ million).............................................................................................................................................................354
Quidel - Revenue by Region, 2005-2008 (US$ million)......................................................................................................................................................................354
Fig.50: Quidel - Revenue by Product Type, 2008.................................................................................................................................................................................354
Fig.51: Quidel - Revenue by Region, 2008...........................................................................................................................................................................................355
Latest Results............................................................................................................................................................................................................................355
Radiometer........................................................................................................................................................................ 356
Blood Gas Analysers...................................................................................................................................................................... 356
1st automatic............................................................................................................................................................................................................................356
ABL80 FLEX................................................................................................................................................................................................................................357
ABL800 FLEX.............................................................................................................................................................................................................................357
ABL77........................................................................................................................................................................................................................................357
ABL5..........................................................................................................................................................................................................................................358
NPT7..........................................................................................................................................................................................................................................358
RADIANCE IT system...................................................................................................................................................................... 358
Quality Control............................................................................................................................................................................... 358
AQT90 FLEX Immunoassay Analyser.......................................................................................................................................... 358
November 2009 ©Espicom Business Intelligence xxi

Roche.........................................................................................................................................................................................................................................359
Veterans Integrated Services Network....................................................................................................................................................................................359
Fig.52: Radiometer - Revenue by Region, 2008..................................................................................................................................................................................360
Response Biomedical.........................................................................................................................................................361
RAMP System.................................................................................................................................................................................. 362
Respiratory Syncytial Virus Test ..............................................................................................................................................................................................362
3M Rapid Detection Flu A+B Test/RAMP Influenza A/B Assay..............................................................................................................................................362
RAMP NT-proBNP Test..............................................................................................................................................................................................................363
Other Cardiac Markers..............................................................................................................................................................................................................363
Foundation for Innovative New Diagnostics...........................................................................................................................................................................363
Roche.........................................................................................................................................................................................................................................364
3M..............................................................................................................................................................................................................................................364
Shionogi....................................................................................................................................................................................................................................364
Response Biomedical - Operating Results, 2004-2008 (C$ thousands).............................................................................................................................................365
Response Biomedical - Product Sales by Category, 2006-2008 (C$ thousands)................................................................................................................................366
Fig.53: Response Biomedical - Product Sales by Category, 2008........................................................................................................................................................366
Response Biomedical - Product Sales by Region, 2006-2008 (C$ thousands)...................................................................................................................................366
Fig.54: Response Biomedical - Product Sales by Region, 2008...........................................................................................................................................................367
Latest Results............................................................................................................................................................................................................................367
Roche Diagnostics............................................................................................................................................................. 368
Professional Diagnostics............................................................................................................................................................... 369
CoaguChek Systems..................................................................................................................................................................................................................369
Cardiac Testing Products..........................................................................................................................................................................................................369
Hospital Blood Glucose Monitoring.........................................................................................................................................................................................371
Urinalysis...................................................................................................................................................................................................................................372
Diabetes Care...................................................................................................................................................................................372
Blood Glucose Meters...............................................................................................................................................................................................................372
Data Management Tools..........................................................................................................................................................................................................373
Current Alliances and Contracts...................................................................................................................................................374
Radiometer...............................................................................................................................................................................................................................374
Response Biomedical................................................................................................................................................................................................................374
Home Diagnostics Inc...............................................................................................................................................................................................................374
bioMérieux................................................................................................................................................................................................................................375
Dade Behring (Siemens)...........................................................................................................................................................................................................375
Roche Diagnostics Operating Results, 2004-2008 (SFr million).........................................................................................................................................................377
Roche Diagnostics Sales by Product Line, 2007-2008 (SFr million)....................................................................................................................................................377
Roche Diagnostics Sales by Region, 2007-2008 (SFr million).............................................................................................................................................................377
Fig.55: Roche Diagnostics - Revenue by Product Line, 2008...............................................................................................................................................................378
Fig.56: Roche Diagnostics - Revenue by Region, 2008........................................................................................................................................................................378
Latest Results............................................................................................................................................................................................................................378
Siemens Healthcare.......................................................................................................................................................... 380
Blood Gas Analyser Range............................................................................................................................................................ 380
xxii ©Espicom Business Intelligence November 2009

RAPIDLab Analysers..................................................................................................................................................................................................................380
RAPIDPoint 340/350 Blood Gas Systems.................................................................................................................................................................................381
RAPIDPoint 400 Series..............................................................................................................................................................................................................381
RapidComm..............................................................................................................................................................................................................................381
PFA-100 Platelet Function Analyser.............................................................................................................................................381
Urinalysis.......................................................................................................................................................................................... 382
Clinitek Advantus Analyzer.......................................................................................................................................................................................................382
Clinitek Status Analyser............................................................................................................................................................................................................382
Multistix10 SG Reagent Strips .................................................................................................................................................................................................382
Clinitek Microalbumin Strips....................................................................................................................................................................................................382
Clinitest hCG Pregnancy Test....................................................................................................................................................................................................383
Diabetes Testing - DCA Vantage Analyser................................................................................................................................. 383
Cardiology....................................................................................................................................................................................... 383
Beckman Coulter.......................................................................................................................................................................................................................383
Roche.........................................................................................................................................................................................................................................384
Sysmex......................................................................................................................................................................................................................................384
Financial Performance ................................................................................................................................................................. 384
Thermo Fisher Scientific................................................................................................................................................... 385
Sure-Vue Tests................................................................................................................................................................................ 385
Remel’s Xpect Tests........................................................................................................................................................................ 386
Alliances .......................................................................................................................................................................................... 386
Trinity Biotech.................................................................................................................................................................... 387
POC HIV Tests.................................................................................................................................................................................. 387
Uni-Gold Recombigen HIV........................................................................................................................................................................................................387
Capillus HIV-1/HIV-2..................................................................................................................................................................................................................388
In Development - TRIstat POC System.....................................................................................................................................................................................388
Uni-Gold Legionella Urinary Antigen (LUA).............................................................................................................................. 388
Akers Biosciences .....................................................................................................................................................................................................................388
Horiba ABX................................................................................................................................................................................................................................388
Clinton Foundation HIV/AIDS Initiative....................................................................................................................................................................................388
Community Healthcare Network.............................................................................................................................................................................................389
Planned Parenthood Federation of America...........................................................................................................................................................................389
Trinity Biotech Operating Results, 2004-2008 (US$ million)..............................................................................................................................................................390
Trinity Biotech - Sales by Product Line, 2004-2008 (US$ million)......................................................................................................................................................390
Fig.57: Trinity Biotech - Sales by Product Type, 2008..........................................................................................................................................................................390
Trinity Biotech - Sales by Geographic Region, 2004-2008 (US$ million)............................................................................................................................................391
Fig.58: Trinity Biotech - Sales by Region Type, 2008...........................................................................................................................................................................391
Latest Results............................................................................................................................................................................................................................391
APPENDICES............................................................................................................................................... 392
APPENDIX 1 - LIST OF ABBREVIATIONS..............................................................................................................................392
APPENDIX 2 - REPORT METHODOLOGY.............................................................................................................................393
November 2009 ©Espicom Business Intelligence xxiii

POC Diagnostics - Future Players and Prospects

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POC Diagnostics - Future Players and Prospects

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POC Diagnostics:

Players, products & future

World Leaders in Health Industry Analysis

ISBN: 978 1 85822 359 9

© Copyright 2009 Espicom Business Intelligence

British Library Cataloguing in Publication Data.

ii ©Espicom Business Intelligence November 2009

November 2009 ©Espicom Business Intelligence iii

iv ©Espicom Business Intelligence November 2009

November 2009 ©Espicom Business Intelligence 

vi ©Espicom Business Intelligence November 2009

Helena Laboratories’ Plateletworks System..............................................................................................................................................................................89

November 2009 ©Espicom Business Intelligence vii

Sysmex’ POCTEM Influenza A/B...............................................................................................................................................................................................105

viii ©Espicom Business Intelligence November 2009

Currently Available H. pylori Tests.......................................................................................................................................................................................................125

November 2009 ©Espicom Business Intelligence ix

Occult Blood Testing......................................................................................................................................................... 140

 ©Espicom Business Intelligence November 2009

November 2009 ©Espicom Business Intelligence xi

xii ©Espicom Business Intelligence November 2009

Breath PulmoHealth Check......................................................................................................................................................................................................205

November 2009 ©Espicom Business Intelligence xiii

Abbott and PSS World Medical................................................................................................................................................................................................220

xiv ©Espicom Business Intelligence November 2009

bioMérieux - Operating Results, 2006-2008 (EUR million)................................................................................................................................................................237

November 2009 ©Espicom Business Intelligence xv

Current Alliances and Contracts.................................................................................................................................................. 255

xvi ©Espicom Business Intelligence November 2009

November 2009 ©Espicom Business Intelligence xvii

xviii ©Espicom Business Intelligence November 2009

HealthCare Asia MediTech........................................................................................................................................................................................................308

November 2009 ©Espicom Business Intelligence xix

Nova Max Link...........................................................................................................................................................................................................................324

xx ©Espicom Business Intelligence November 2009

Quest Diagnostics.............................................................................................................................................................. 342

November 2009 ©Espicom Business Intelligence xxi

xxii ©Espicom Business Intelligence November 2009

November 2009 ©Espicom Business Intelligence xxiii

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