WHO Prequalification of Diagnostics Update · COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0...
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AMDS ANNUAL STAKEHOLDERS AND PARTNERS MEETING 08 May 2013 1 | WHO Prequalification of Diagnostics Update AMDS Annual Stakeholders and Partners meeting 7-8 May 2013, Geneva Mercedes Pérez González Diagnostics & Laboratory Technology Department of Essential Medicines & Health Products
Transcript of WHO Prequalification of Diagnostics Update · COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0...
AMDS ANNUAL STAKEHOLDERS AND PARTNERS MEETING 08 May 2013 1 |
WHO Prequalification of
Diagnostics Update
AMDS Annual Stakeholders and Partners meeting
7-8 May 2013, Geneva
Mercedes Pérez González
Diagnostics & Laboratory Technology
Department of Essential Medicines & Health Products
AMDS ANNUAL STAKEHOLDERS AND PARTNERS MEETING 08 May 2013 2 |
Contents
Market Context
WHO Prequalification of Diagnostics programme
Remaining challenges
Next steps
AMDS ANNUAL STAKEHOLDERS AND PARTNERS MEETING 08 May 2013 3 |
Value of Procurement (USD)
HIV Diagnostics (all assay types)
procurement based on available data
Analysis of available data WHO (direct), SCMS (direct), UNICEF (direct), Global Fund (PQR – verified data) and UNITAID (GPRM) Ex-works data only.
2008 2009 2010 2011 2012
WHO 622,254 756,036 553,432 793,760 1,930,586
UNICEF 12,203,798 11,217,332 17,568,866 20,816,528 13,971,190
SCMS 26,437,845 26,260,396 20,670,368 34,397,547 32,461,034
GPRM for UNITAID 2,764,650 1,465,585
GFATM PQR 1,472,329 12,428,701 3,743,473 36,656,888 6,520,112
0
10,000,000
20,000,000
30,000,000
40,000,000
50,000,000
60,000,000
70,000,000
80,000,000
90,000,000
100,000,000N
um
be
r o
f Te
sts
2008 2009 2010 2011 2012
39,553,314.19 48,930,034.00 42,307,520.24 83,978,605.58 51,410,128.67
Grand Total 43,500,876 50,662,465 44,001,724 92,664,723 54,882,922
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Total Volume of HIV Test Procurement PQ vs
non-PQ (all assay types, all data)
2008 2009 2010 2011 2012
Non-Prequalified 13,591,476.00 14,793,065.00 4,710,660.00 28,431,590.00 7,902,508.00
Prequalified 29,909,400.00 35,869,400.00 39,291,064.00 64,233,133.00 46,980,414.00
0.00
10,000,000.00
20,000,000.00
30,000,000.00
40,000,000.00
50,000,000.00
60,000,000.00
70,000,000.00
80,000,000.00
90,000,000.00
100,000,000.00
Nu
mb
er o
f Te
sts
% Prequalified 68.49 70.64 88.79 69.03 85.44
% Non-Prequalified
31.51 29.36 11.21 30.97 14.56
AMDS ANNUAL STAKEHOLDERS AND PARTNERS MEETING 08 May 2013 5 |
Market Share by Volume of Procurement (HIV all
assays) 2012
75%
6%
5%
4% 4%
2% 1%
1%
0%
0% 0% 0%
0%
0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0%
Determine™ HIV-1/2
Uni-Gold™ HIV
ImmunoComb® II HIV 1&2 BiSpot
HIV 1/2 STAT-PAK®
First Response® HIV 1-2-0 Card Test
Diagnostic Kit for HIV (1+2) Antibody(Colloidal Gold)
ANTI-HIV 1 + 2 Antibodies ELISADiagnostics Kit
OraQuick® HIV-1/2 Rapid AntibodyTest
Murex HIV Ag/Ab Combination
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Market Share by Volume of Procurement (HIV all
assays) 2011
62% 16%
11%
4%
1% 1% 1%
1%
0% 0%
0%
0%
0%
0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0%
Determine™ HIV-1/2
Diagnostic Kit for HIV (1+2) Antibody(Colloidal Gold)SD BIOLINE HIV 1/2 3.0
Uni-Gold™ HIV
HIV 1/2 STAT-PAK® Dipstick
HIV 1/2 STAT-PAK®
PAREEKSHAK® HIV 1/2 Triline Card Test
ANTI-HIV 1 + 2 Antibodies ELISADiagnostics KitFirst Response® HIV 1-2-0 Card Test
Murex HIV Ag/Ab Combination
One Step HIV 1/2 WholeBlood/Serum/Plasma Test
AMDS ANNUAL STAKEHOLDERS AND PARTNERS MEETING 08 May 2013 7 |
Contents
Market info
WHO Prequalification of Diagnostics programme
Remaining challenges
Next steps
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To promote and facilitate access to safe &
appropriate diagnostic technologies of good
quality in an equitable manner
To increase in-country capacity to
effectively regulate & to monitor quality in-
market
Customers
– WHO Member States
– UN agencies
– Funding and procurement agencies
Aim of WHO Prequalification of Diagnostics
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Prequalification of Diagnostics
Application by Manufacturer
Meets
Requirements
Dossier
Assessment
Manufacturing
Site Inspection
Laboratory
Evaluation
Product Prequalified
Post Market Surveillance
http://www.who.int/diagnostics_laboratory/evaluations/en/See WHO website for more details
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Recent progress
Products prequalified in 2010 1
Products prequalified in 2011 10
Products prequalified in 2012 8
Products prequalified in 2013 2
Products Anticipated for 2013 10
Products closed 36
Products withdrawn 20
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WHO Prequalified Products (Simple/Rapid
tests)
As of 06 May 2013
•More information and WHO Public Reports can be found on the WHO website www.who.int/diagnostics_laboratory
Product name Manufacturer Manufacturing site(s)
SD Bioline HIV Ag/Ab Combo Standard Diagnostics, Inc. Giheung-ku, Republic of Korea
Uni-Gold™ HIV Trinity Biotech Manufacturing Ltd. Bray, Ireland
Alere Determine HIV-1/2 Ag/Ab Combo Alere Medical Co. Ltd. Matsudo-shi, Chiba-ken, Japan
HIV 1/2 STAT-PAK® Chembio Diagnostic Systems Inc. Medford, NY, USA
Alere Determine HIV-1/2 Alere Medical Co. Ltd. Matsudo-shi, Chiba-ken, Japan
Alere Determine HIV-1/2 Alere Medical Co. Ltd. Matsudo-shi, Chiba-ken, Japan
HIV 1/2 STAT-PAK® Dipstick Chembio Diagnostic Systems Inc. Medford, NY, USA
IMMUNOQUICK® Malaria Falciparum Biosynex Strasbourg, France
SD BIOLINE Malaria Ag P.f Standard Diagnostics, Inc. Giheung-ku, Republic of Korea
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WHO prequalified products (HIV viral load
and CD4 Technologies)
As of 07 May 2013
•More information and WHO Public Reports can be found on the WHO website www.who.int/diagnostics_laboratory
Product name Manufacturer Manufacturing site(s)
BD FACSCount Instrument System with FACSCount Control Kit and BD
FACSCount Reagent Kit (Absolute CD4+, CD8+, and CD3+ Counts)
Becton, Dickinson and Company, BD
Biosciences
San Jose, CA, USA
BD FACSCount Instrument System with FACSCount Control Kit and BD
FACSCount CD4 Reagent Kit (Absolute and Percentage CD4+ Counts)
Becton, Dickinson and Company, BD
Biosciences
San Jose, CA, USA
Pima CD4 Test Alere Technologies GmbH Jena, Germany
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 48) Roche Molecular Systems Inc. Branchburg, NJ, USA
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 96) Roche Molecular Systems Inc. Branchburg, NJ, USA
VERSANT® HIV-1 RNA 1.0 Assay (kPCR) Siemens Healthcare Diagnostics Tarrytown NY, USA
NucliSENS EasyQ® HIV-1 v2.0 (Automated) bioMérieux SA Marcy L’Etoile, France
NucliSENS EasyQ® HIV-1 v2.0 (Semi-Automated) bioMérieux SA Marcy L’Etoile, France
Abbott RealTime HIV-1 (Manual) Abbott Molecular Inc. Des Plaines, IL, USA
Abbott RealTime HIV-1 (m2000sp) Abbott Molecular Inc. Des Plaines, IL, USA
Abbott RealTime HIV-1 (m24sp) Abbott Molecular Inc. Des Plaines, IL, USA
AMDS ANNUAL STAKEHOLDERS AND PARTNERS MEETING 08 May 2013 13 |
PQ Dx progress: applications and dossiers
Applications:
98 priority applications accepted
36 applications closed
Dossiers:
84 dossiers received
– 38 HIV – 6 CD4
– 12 malaria – 12 VL (2 EID)
– 10 HCV – 6 HBV
79 dossiers screened
– All required amendments
25 dossiers under full assessment
53 full dossiers assessments completed
Status as of 07May 2013, based on analysis of PQ tracking document
36%
16%6%
13%
12%
10%
7%
Prioritized applications, by type
HIV rapid / other Malaria rapid CD4
HIV EIA HIV VL HCV
HBV
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PQ Dx progress: laboratory evaluations
18 HIV RDTs completed
– 4 ongoing
4 HIV EIA completed
3 CD4 technologies completed
HIV-1 viral load on dried blood
spot (DBS) results Q3 2013
Malaria RDTs completed under
WHO/TDR product testing
programme
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PQ Dx progress: Inspections
2010: inspected 14 products
2011 : inspections :
– Number of products inspected : 20
– Number of products re- inspected : 4
2012 : inspections :
– Number of products inspections conducted : 16
• (some Mx action plans pending )
– Number of re-inspections conducted : 4
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Contents
Market info
WHO Prequalification of Diagnostics programme
Remaining challenges
Next steps
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Challenges
Different categories of IVDs regulated differently
– HIV IVDs, particularly for blood screening, attract greatest
stringency
– Degree of stringency is usually risk-based
– Risk classification is different in different settings
Multiple regulatory versions for the "same product"
– Both stringently and less-stringently controlled products
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Challenges
Still poor understanding and implementation of quality
management systems at manufacturing site
Inadequate product dossier to demonstrate performance
claims including
– Inadequate demonstration of product stability
• Both in-use and transportation stability
– Inadequate lot release procedures
– Inadequate customer service
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Contents
Market info
WHO Prequalification of Diagnostics programme
Remaining challenges
Next steps
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Next steps
Prequalify additional products: target 10 products in 2013
Extend Prequalification to new product categories of public
health value
– Hepatitis B, Hepatitis C, combined HIV-syphilis RDTs and male
circumcision devices
Amplifying post-market surveillance activities
Strengthening regulatory capacity in both country of origin
and country of sale and use
– RDTs are often not widely, if at all, used in the country of origin
AMDS ANNUAL STAKEHOLDERS AND PARTNERS MEETING 08 May 2013 21 |
Updated information
The status of each PQDx
application is posted on the
WHO website & updated
monthly
The PQ Update newsletter
is issued regularly & sent by
direct mail & posted on the
WHO website
Thank you
www.who.int/diagnostics_laboratory
Email: [email protected]
