MDx32012 L2 C1 Elearning How To Sell TX Panel Assays

Sample & Assay Technologies
How to sell the artus® QS-RGQ Tx portfolio
2012 Part 1 of 2 – Konstantinos Kostidis

Sample & Assay Technologies How to sell the artus® QS-RGQ Tx portfolio
Agenda
Introduction, Strategy and Customers needs
Analysis of Competitive Offers
How to Sell against the Competition
Summary
2
Sample & Assay Technologies Introduction, Strategy and Customers needs
What is the need of customers?

A specific clinical need:
 Most the Tx panel of viruses have a global prevalence of >80%
 Transplanted patients are on immunosuppressive drugs
 Those viruses create life-threatening diseases for transplanted patients
 Physicians have the option to:
– Reduce immunosuppressive drugs, but risk graft rejection
– Treat with specific drugs, but risk resistance or non-response
 The need is then to know whether a viral infection re-emerges and at
which rate, in order to adopt the most suitable treatment approach
A specific diagnostic need:

 Sensitive and specific assays
 Always part of a convenient workflow
 Flexibility is key, as demands are different between patients
 Offer a VL measurement or the individual patient’s VL threshold to
physician
 Guidelines not really established, tests are hospital- or lab-specific
Title, Location, Date 3

Agenda
 Roche
 Abbott
 Argene-bioMérieux
 Nanogen-Elitech
 Altona Diagnostics
 Performance assessment
How to sell against the competition
Summary

Sample & Assay Technologies Analysis of Competitive Offers
Roche menu – sample types
Lightcycler Manual / Cobas Amplicor CAP/ CTM

Parameters
Sample CE-IvD Sample Sample CE-IvD Sampl Sample CE-IvD Sample

prep. status type prep. Status e type prep. Status type
CE-IvD Plasma / CE-IvD CE-IvD

CMV Manual Manual Plasma Autom. Plasma
QT (*) WB QT QT
CE-IvD Plasma /
EBV Manual – – – – – –
QT WB
CE-IvD CSF /
HSV Manual – – – – – –
QL (*) Swabs
CE-IvD CSF /
VZV Manual – – – – – –
QL Swabs
BKV – – – – – – – – –
(*) QT: Quantitative; QL: Qualitative

Analysis of the Roche offer
Advantages Disadvantages
 Large installed base of LightCyclers  No complete offer for Tx testing

 Solid, widely documented assay  The only semi- complete offer is on
performance LightCycler, but only with manual extraction
 Appropriate sample types  MagNA Pure is NOT validated
 HSV and VZV are only qualitative
 There is no BKV offer
 No offer with Cobas Taqman means that
laboratories running BBVs and Tx will need
several instruments

Agenda
 Roche
 Abbott
 Nanogen-Elitech
Summary

Abbott menu – sample types
Abbott m2000
Sample
Parameter CE-IvD Status Sample type Remarks
preparation
Plasma, Whole Quantitative
CMV Automated CE-IvD
blood artus OEM
EBV Manual CE-IvD N/A* Qualitative
HSV Manual CE-IvD N/A* Qualitative
VZV Manual CE-IvD N/A* Qualitative
BKV - - - No kit
Parvo B19 Manual CE-IvD * Qualitative
 Majority of assays manual and mainly qualitative
N/A: Information from official website not available

Analysis of the Abbott offer
 Abbott is able to show a good assay menu  Abbott’s m2000 automated instrument is
in their MDx catalogue only validated their CMV kit
 No BKV offer
 EBV, HSV and VZV are only qualitative
 CMV: QIAGEN kit

Agenda
 Roche
 Abbott
 Nanogen-Elitech
Summary

Argene-bioMérieux menu – sample types
Sample CE-IvD
Parameter Sample type Remarks
preparation Status
CMV + HHV6/7/8 Manual CE Plasma, WB, Serum, Amniotic fluid, CSF, Complete kit
CMV Manual CE Urine, BAL, Biopsy Complete kit
HSV 1, 2 + VZV Manual CE Plasma, Cell cutlure, CSF, BAL, Gyn. smear Complete kit
Manual WB, Plasma, CSF, BAL, Biopsy, Tissue, Cell
EBV CE Complete kit
Culture
BKV Manual CE WB, Urine Complete kit
Manual WB, Plasma, CSF, BAL, Urine,
Adenovirus CE Complete kit
Nasopharyngeal specimen, Stool
Enterovirus Manual CE CSF, Stool, Respiratory, Cell Culture Complete kit
Bordetella Manual CE Nasopharyngeal samples Complete kit
HSV 1 Manual „CE“ Same as above Primers & probes
HSV 2 Manual „CE“ Same as above Primers & probes
VZV Manual „CE“ Same as above Primers & probes
JCV Manual RUO Same as above Primers & probes
BKV Manual RUO Same as above Primers & probes
 A catalogue of 6 assays, 2 combos, plus Primers & Probes

Argene-bioMérieux Tx portfolio – specifications
Kit LOD ROQ (highest) Sample type
50 cop/ml (flyer)
CMV 107 cop/ml
1125 cop/ml (handbook) WB, Plasma, Serum, CSF,
Amniotic Fluid, Urine, BAL,
HHV-6 156 cop/ml 107 cop/ml
Biopsy
HHV-8 40 cop/ml 107 cop/ml
HSV 1 2 cop/PCR 5 x 105 cop/PCR
CSF, Gyn. smear, BAL,
HSV 2 2 cop/PCR 5 x 105 cop/PCR
Plasma, Cell Culture
VZV 2 cop/PCR 5 x 105 cop/PCR
WB, Plasma, CSF, BAL,
EBV 4 cop/PCR = 182 cop/ml 5 x 106 cop/PCR
Biopsy, Tissue, Cell Culture
WB, Plasma, CSF, BAL, Urine,
200 cop/ml (WB),
Adenovirus 5x 106 cop/ml Nasopharyngeal specimen,
261 cop/ml (Nasal secretion)
Stool
0.01 (COXA13) TO 10 (PV1) CSF, Stool, Respiratory, Cell
Enterovirus N/A
TCID50/ML. Culture
Bordetella 10 gEq/ml N/A Nasopharyngeal samples
BK 65 cop/ml 1011 cop/ml WB, Urine
 A very confusing way to present performance data (cop/ml, cop/PCR)

Why primers & probes are not considered Diagnostic products
 Re-validation is mandatory with P&P

 Lab has to revalidate the whole workflow
 Each change in enzymes, material, reagents  revalidation
 Re-validation is long for customers
 Long analytical performance assessment
– Sensitivity, specificity
– Reproducibility, repeatability, etc.
 Several full days of work
– Validation protocols described in all QIAGEN handbooks
– This point may be not known by customers
 Can primers & probes be CE-IvD ?
 No, not anymore, only workflow can be CE-IvD certified, not
reagents by themselves
 This point is not known to customers
 Primers & Probes are not really different from in-house testing,
just easier to order
 It makes testing cumbersome, not fully CE-IvD

Validation of the Argene-bioMérieux assay menu seems incredible

 CMV assay (r-gene 69-003) is validated with
 9 sample types
 8 Extraction solutions
 7 Q-PCR instruments
 How is it possible ?
 “Validated” means
– All analytical data are available
– All performance data are documented
– 9x8x7= 504 possibilities of workflow.
 Argene has to have data for those 504 possibilities
– Each time a reference change, they need to revalidate
– Eg RG 6000  RG-Q : revalidation needed on all sample
types, all extraction method. 72 workflows are claimed!
 Have these validations been done? Are these data available?
– Not in the handbook, only 1 : whole blood, MagNA Pure, ABI
cycler
– Not on the website
– ………. Nowhere
 We have a lot of doubt about reality of validation in Argene

CMV kit by Argene-bioMérieux
Contradictory performance data:  But in the flyer: LOD of 50 cop/ml

 Handbook : “Results indicate a 95%  What is the real LOD ? The one
probability of detecting CMV in whole calculated and presented in the
blood containing 1125 cop/ml using handbook, as asked by CE-IvD
CMR r-gene” regulation
 This is the definition of LOD  Real LOD is 555 cop/ml in whole
blood with MagNA Pure compact
and ABI
(prod. code 69-003) version 230211, chapter 15,2 p. 20
 No data from other workflow

Extract from Argene “CMV R-gene” kit Handbook
Extract from Argene Product Catalogue 2011, p. 5
 Argene communicates contradictory and often

untrue statements to clients

CE-IvD Validation situation in Argene-bioMérieux
 Only a single piece of workflow data is shown in handbook

 Other data not produced ?
 Other data really not good ?
– We know that LOD can vary a lot between sample type
and instruments
 Consequences for customers

 Risk in case of laboratory accreditation
 CE-IvD status of Argene’s Primers & probes-based workflow is
questionable
 Lab has to revalidate Primers & Probes-based workflow to
ensure CE-IvD validity (which is the same procedure with
using QIAGEN kits off-label)
 Medical risk is the workflow performance is not validated : who
can say they are missing patients ?
 Argene offer is highly uncertain, so should be users

Analysis of the Argene-bioMérieux offer
 Catalogues and flyers show a long list of  Catalogue is mainly primers & probes
assays, validated with many sample types  P&P requires full and cumbersome
and a broad range of extraction and validation
detection instruments  Needs revalidation after each change
 Most of Argene’s assays share identical  Handbooks are confusing, allowing room
cycling conditions and can therefore be run for error
in parallel in the same PCR run
 Performance data are not clear: cop/ml,
cop/PCR
 Argene’s validation claims and analytical
specifications leave a lot of room for doubt

Agenda
 Roche
 Abbott
 Nanogen-Elitech
Summary

Nanogen-Elitech menu – sample types
Sample CE-IvD
preparation Status
Plasma, WB, leucocyte &

CMV Manual CE granulocyte suspensions
Complete kit
WB, leucocyte & granulocyte

EBV Manual „CE“ suspensions
Primers & Probes
HSV 1 Manual „CE“ Plasma, Mucus Swabs Primers & Probes
HSV 2 Manual „CE“ Plasma, Mucus Swabs Primers & Probes
VZV Manual „CE“ Plasma, Mucus Swabs, CSF Primers & Probes
Plasma, WB, leucocyte &
HHV 6 Manual „CE“ lymphomonocyte suspensions
Primers & Probes
WB, leucocyte &

HHV 8 Manual „CE“ lymphomonocyte suspensions
Primers & Probes
BKV Manual „CE“ Plasma, urine Primers & Probes
JCV Manual „CE“ Plasma, urine Primers & Probes
Enterovirus Manual „CE“ Plasma Primers & Probes
 A catalogue of 1 complete kit, 10 P&Ps

Nanogen-Elitech menu – Tx portfolio - Specifications
Parameters Sample type Extraction validated Detection validated
CMV WB + Plasma Manual ABI 7000
EBV Plasma Manual ABI 7000
HSV 1 Plasma + Swabs Manual ABI 7000
HSV 2 Plasma + Swabs Manual ABI 7000
VZV Plasma + Swabs + CSF Manual ABI 7000
HHV 6 WB + Plasma Manual ABI 7000
HHV 8 WB + Plasma Manual ABI 7000
BKV Plasma + Urine Manual ABI 7000
JCV Plasma + Urine Manual ABI 7000
Enterovirus Plasma Manual ABI 7000
 Assays are validated with manual extraction only on ABI

CMV kit by Nanogen-Elitech
 Kit design
 4 standards, 1 internal control
 96 Rx
 Extraction
 Validated on plasma, whole blood
 Only manual extraction (2 different extraction kits for WB and
cells), sold for 50 samples
 Detection
 Performance evaluated on ABI 7000
 No info on other solution
 Results in geq/ml, no possible to compare
 Nanogen‘s CMV kit is for manual extraction, ABI 7000 validated only!

EBV kit by Nanogen-Elitech
 Kit design
 5 Kits to be ordered separately for each parameter :
Amplimix, Ampliprobe, Standard, Positive control, Extracell
for manual extraction
 96 Rx only, Extraction is delivered for 50 Rx
 Extraction
 Only manual validated
 Intended use : whole blood and cells
 Detection : Validated only on ABI prism 7000
 Protocols include centrifugation steps
 No internal control. Standards are used for positive controls
 Lots of pipetting : Pipet samples, water, standard
 Data reported in genome equivalent / 100 000 cells, not
IU/ml
 Manual kit, to be used on ABI 7000 only

Analytical Performance of all Nanogen-Elitech kits
 All kits have exactly the same LOD : 10 cop/reaction

 This is strange, all kits have exactly the same LOD
 All performance given in cop/reaction
 Validated only on ABI prism 7000

 Protocols include centrifugation steps
 No internal control. Standards are used for positive controls
 Lots of pipetting : Pipet samples, water, standard
 Performance highly doubtful, all parameters & sample types

have the same LOD ?

Analysis of the Nanogen-Elitech offer
 Attractive list of parameters  Only manual extraction and ABI 7000

 Easy to use: same reagents and same validated
cycling conditions  Complex to use
 Kit of 50 Rx for extraction and 96 Rx for
detection
 Many pipetting steps
 Results reported in gEq/reaction makes
it challenging to compare results with
literature
 Inernal control not avaialble for all kits
 Very strange performance claims: all kits
have the same LOD and linear range,
irrespective of parameter and sample type
used

Agenda
 Roche
 Abbott
 Nanogen-Elitech
Summary

Altona Diagnostics menu – sample types
Sample CE-IvD
preparation Status
CMV Manual CE-IvD EDTA plasma
Manual &
EBV CE-IvD Not specified
Automated
Manual & Stratagene: Mx 3005P
HSV 1/2 CE-IvD Not specified
Automated
Abbott: m200rt
Manual & Siemens: VERSANT kPCR
VZV CE-IvD Not specified
Automated
ABI Prism: 7500 SDS/F-SDS
Manual & Roche: LC 480, 1.2, 1.5, 2.0
BKV CE-IvD Not specified
Automated
QIAGEN: RG 3000/6000/Q
Manual & Cepheid: SmartCycler II
JCV CE-IvD Not specified
Automated
Manual &
Enterovirus CE-IvD Not specified
Automated
Manual &
Adenovirus CE-IvD Not specified
Automated

Analysis of the Altona offer
 Attractive MDx portfolio with almost  Smaller MDx portfolio compared to

complete Tx panel QIAGEN
 (Allegedly) Validated with a broad range of  No BBV menu
qPCR instruments  No automation
 Altona does not state what sample types
their assays are validated with!
 Altona only offers recommendation for
extraction instruments, no validation
 Altona does not clearly specify
performance data for extraction & qPCR
combinations leading to confusion

Agenda
 Roche
 Abbott
 Nanogen-Elitech
Summary

Overview performance characteristics: CMV
165 (whole blood) 80x10E8

artus® QS-RGQ CMV
42 (plasma)
235 2x10E7
Roche Lightcycler CMV
20 (p), 40 (WB) 20x10E8

Abbott CMV
50 (flyer) 555 (handbook) 1x10E7

Argene CMV kit
All nanogen kits

285 2,85x10E7 have the same
Nanogen CMV kit performance !
120 (plasma) 10E9.5 (plasma)
Altona CMV kit
1 10 100 1000 104 105 106 107 108 109

Viral load cop/ml
 The best kit on the market is the artus® CMV assay
Source : handbooks & Flyers

Overview performance characteristics: EBV

284 (whole blood) 5x10E7 (whole blood)
artus® QS-RGQ EBV
157 (plasma) 1x10E7 (plasma)
359 (WB) 2x10E7 WB + p)

Roche Lightcycler EBV
229 (p)
Abbott EBV [Not available]
182 (WB) 5x10E6

Argene EBV kit
285 2,85x10E7
Nanogen EBV kit
All Nanogen kits

have the same
Altona CMV kit Data not shown performance !
1 10 100 1000 104 105 106 107 108 109

Viral load cop/ml
 The best kit on the market is the artus® EBV assay
Source : handbooks & Flyers

MDx32012 L2 C1 Elearning How To Sell TX Panel Assays

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Sample & Assay Technologies

How to sell the artus® QS-RGQ Tx portfolio

2012 Part 1 of 2 – Konstantinos Kostidis

Introduction, Strategy and Customers needs

Analysis of Competitive Offers

How to Sell against the Competition

What is the need of customers?

A specific diagnostic need:

Title, Location, Date 3

Introduction, Strategy and Customers needs

Analysis of Competitive Offers

How to sell against the competition

Title, Location, Date 4

Roche menu – sample types

Lightcycler Manual / Cobas Amplicor CAP/ CTM

Sample CE-IvD Sample Sample CE-IvD Sampl Sample CE-IvD Sample

CE-IvD Plasma / CE-IvD CE-IvD

(*) QT: Quantitative; QL: Qualitative

Analysis of the Roche offer

 Large installed base of LightCyclers  No complete offer for Tx testing

Title, Location, Date 6

Introduction, Strategy and Customers needs

Analysis of Competitive Offers

How to sell against the competition

Title, Location, Date 7

Abbott menu – sample types

EBV Manual CE-IvD N/A* Qualitative

HSV Manual CE-IvD N/A* Qualitative

VZV Manual CE-IvD N/A* Qualitative

Parvo B19 Manual CE-IvD * Qualitative

 Majority of assays manual and mainly qualitative

N/A: Information from official website not available

Analysis of the Abbott offer

Title, Location, Date 9

Introduction, Strategy and Customers needs

Analysis of Competitive Offers

How to sell against the competition

Title, Location, Date 10

Argene-bioMérieux menu – sample types

 A catalogue of 6 assays, 2 combos, plus Primers & Probes

Argene-bioMérieux Tx portfolio – specifications

Kit LOD ROQ (highest) Sample type

Title, Location, Date 12

Why primers & probes are not considered Diagnostic products

 Re-validation is mandatory with P&P

Title, Location, Date 13

Validation of the Argene-bioMérieux assay menu seems incredible

Title, Location, Date 14

CMV kit by Argene-bioMérieux

Contradictory performance data:  But in the flyer: LOD of 50 cop/ml

 No data from other workflow

Extract from Argene Product Catalogue 2011, p. 5

 Argene communicates contradictory and often

Title, Location, Date 15

CE-IvD Validation situation in Argene-bioMérieux

 Only a single piece of workflow data is shown in handbook

 Consequences for customers

 Argene offer is highly uncertain, so should be users

Title, Location, Date 16

Analysis of the Argene-bioMérieux offer

Title, Location, Date 17

Introduction, Strategy and Customers needs

Analysis of Competitive Offers