AIDS2012 – WHO Satellite Session l 25 July 20121 |
Current pipeline for WHO PQ of Diagnostics programme
How WHO is bringing innovative POC diagnostics to the field and assuring quality
AIDS2012 Satellite Session 25 July 2012, Washington DC
Anita SandsDiagnostics & Laboratory Technology
Department of Essential Medicines & Health Products
AIDS2012 – WHO Satellite Session l 25 July 20122 |
Contents
Market share
WHO Prequalification of Diagnostics programme
Remaining challenges
Next steps
AIDS2012 – WHO Satellite Session l 25 July 20123 |
Global market for diagnostics
2008 2009 2010 20110
10,000,000
20,000,000
30,000,000
40,000,000
50,000,000
60,000,000
70,000,000
Volume of Procurement (number of tests)N
umbe
r of T
ests
2008 2009 2010 2011HIV Test Procurement by WHO and UNICEF 12,824,052 11,973,368 18,021,498 21,681,040Total Value of Procurement HIV Tests 37,330,367 36,759,746 38,142,075 58,068,300
Value of procurement (USD)
Based on available data from SCMS, UNICEF, WHO, UNITAID (when available) and GFATM
AIDS2012 – WHO Satellite Session l 25 July 20124 |
2008 HIV RDTs Market Share by Volume
56.559%
7.425%
7.095%
3.897%
5.827%
15.587%
3.609%Determine™ HIV-1/2Uni-Gold™ HIVSD BIOLINE HIV 1/2 3.0First Response® HIV 1-2-0 Card TestHIV 1/2 STAT-PAK®Diagnostic Kit for HIV (1+2) An-tibody (Colloidal Gold)DoubleCheckGold™ HIV1&2 Whole BloodOther (32 tests)
AIDS2012 – WHO Satellite Session l 25 July 20125 |
2010 HIV RDTs Market Share by Volume
83.756%
5.596%
5.468%
.106%
.481%
1.042% .041% 3.510%
Determine™ HIV-1/2Uni-Gold™ HIVSD BIOLINE HIV 1/2 3.0First Response® HIV 1-2-0 Card TestHIV 1/2 STAT-PAK®Diagnostic Kit for HIV (1+2) An-tibody (Colloidal Gold)DoubleCheckGold™ HIV1&2 Whole BloodOther (32 tests)
AIDS2012 – WHO Satellite Session l 25 July 20126 |
Contents
Market share
WHO Prequalification of Diagnostics programme
Remaining challenges
Next steps
AIDS2012 – WHO Satellite Session l 25 July 20127 |
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
Aim of WHO Prequalification of Diagnostics
AIDS2012 – WHO Satellite Session l 25 July 20128 |
WHO Prequalification of Diagnostics Application by Manufacturer
Meets Requirements
DossierAssessment
Manufacturing Site Inspection
Laboratory Evaluation
Product Prequalified
Post Market Surveillance
See WHO website for more details http://www.who.int/diagnostics_laboratory/evaluations/en /
AIDS2012 – WHO Satellite Session l 25 July 20129 |
PQ Dx applications received
Status as of 20 July 2012, based on analysis of PQ tracking document
Total OtherVirological
Technologies
CD4 Technologie
sRapid Tests EIA
80 5 14 9 43 9 HIV
1 0
0 N/A
1 0 HIV/HCV
1 0 1 0 HIV/syphilis
19 1 10 8 HCV
14 0 8 6 HBV
37 0 35 2 Malaria
152 6 14 9 96 25 Total
Test format
Analyte
AIDS2012 – WHO Satellite Session l 25 July 201210 |
Recent progress
1 Products prequalified in 2010
13 Products prequalified in 2011
5 Products prequalified in 2012
Further 5-10 Products anticipated for prequalification in 2012
22 Products closed
20 Products withdrawn
Status as of 20 July 2012, based on analysis of PQ tracking document
AIDS2012 – WHO Satellite Session l 25 July 201211 |
WHO prequalified products (HIV RDTs)
Product name Catalogue number(s) Manufacturer Manufacturing site(s) Date prequalified
Alere Determine HIV-1/2 7D2342 Alere Medical Co. Ltd. Matsudo-shi, Chiba-ken, Japan 25-Nov-11
Alere Determine HIV-1/2 7D2343 Alere Medical Co. Ltd Matsudo-shi, Chiba-ken, Japan 25-Nov-11
Alere Determine HIV-1/2 Ag/Ab Combo 7D2643 and 7D2243 Alere Medical Co. Ltd Matsudo-shi, Chiba-ken,
Japan 19-Mar-12
HIV 1/2 STAT-PAK® Dipstick HIV303 Chembio Diagnostic Systems Inc. Medford, NY, USA 25-Nov-11
HIV 1/2 STAT-PAK® HIV101 Chembio Diagnostic Systems Inc. Medford, NY, USA 16-Jan-12
As of 20 July 2012• More information and WHO Public Reports can be found on the WHO website www.who.int/diagnostics_laboratory
In addition, list of products eligible for WHO procurement still stands until sufficient number of prequalified products (all have submitted for PQDx)
AIDS2012 – WHO Satellite Session l 25 July 201212 |
Product name Catalogue number(s) Manufacturer Manufacturing site(s) Date prequalified
SD BIOLINE Malaria Ag P.f 05FK50 Standard Diagnostics, Inc.
Giheung-gu, Republic of Korea
06-Dec-10*Notice of Concern
SD BIOLINE Malaria Ag P.f 05FK53 Standard Diagnostics, Inc.
Giheung-gu, Republic of Korea
06-Dec-10*Notice of Concern
IMMUNOQUICK® Malaria Falciparum 0502_K100 Biosynex Strasbourg, France 18-Oct-11
IMMUNOQUICK® Malaria Falciparum 0502_K50 Biosynex Strasbourg, France 18-Oct-11
IMMUNOQUICK® Malaria Falciparum 0502_K25 Biosynex Strasbourg, France 18-Oct-11
WHO prequalified products (malaria RDTs)
As of 20 July 2012• More information and WHO Public Reports can be found on the WHO website www.who.int/diagnostics_laboratory
AIDS2012 – WHO Satellite Session l 25 July 201213 |
WHO prequalified products (CD4 technologies)
Product name Catalogue number(s) Manufacturer Manufacturing site(s) Date prequalified
Pima CD4 Test 260100100 and 260300001 Alere Technologies GmbH Jena, Germany 25-Nov-11
*conditional
As of 20 July 2012• More information and WHO Public Reports can be found on the WHO website www.who.int/diagnostics_laboratory
AIDS2012 – WHO Satellite Session l 25 July 201214 |
WHO prequalified products (HIV viral load technologies)
Product name Catalogue number(s) Manufacturer Manufacturing site(s) Date prequalified
Abbott RealTime HIV-1 (Manual)
2G31 (2G31-90, 2G31-80, 2G31-70), 2G31-66, 1L68-09, 9K15-01, 04J70-
24, 04J71-93Abbott Molecular Inc. Des Plaines, IL, USA 17-Oct-11
*fast-tracked
Abbott RealTime HIV-1 (m2000sp)
2G31 (2G31-90, 2G31-80, 2G31-70), 2G31-66, 1L68-09, 9K15-01, 04J70-
24, 04J71-93, 9K14-02Abbott Molecular Inc. Des Plaines, IL, USA
17-Oct-11*fast-tracked
Abbott RealTime HIV-1 (m24sp)
3N06-01, 2G31(2G31-90, 2G31-80, 2G31-70), 2G31-66, 1L68-09, 9K15-
01, 04J70-24, 04J71-93Abbott Molecular Inc. Des Plaines, IL, USA
17-Oct-11*fast-tracked
NucliSENS EasyQ® HIV-1 v2.0 (Semi-Automated),
240140, 280130, 280131, 280132, 280133, 280132, 280134, 285056,
2000309, 285033bioMérieux Marcy L’Etoile,
France
23-Dec-11*fast-tracked
NucliSENS EasyQ® HIV-1 v2.0 (Automated)
200305, 200293, 200292, 285056, 2000309, 285033 bioMérieux
Marcy L’Etoile, France
23-Dec-11*fast-tracked
As of 20 July 2012• More information and WHO Public Reports can be found on the WHO website www.who.int/diagnostics_laboratory
AIDS2012 – WHO Satellite Session l 25 July 201215 |
WHO prequalified products (HIV viral load technologies)
Product name Catalogue number(s) Manufacturer Manufacturing site(s) Date prequalified
VERSANT® HIV-1 RNA 1.0 Assay (kPCR)
10375763, 10375764, 104801677, 04801685, 10467524
Siemens Healthcare Diagnostics Tarrytown NY, USA 13-Feb-12
*fast-tracked
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version
2.0 (TaqMan 48)
03279332001, 03051315001, 05212294190, 03587797190, 04862392001, 05807875001,
05527503001
Roche Molecular Systems
Inc.
Branchburg, NJ, USA
1-May-2012*fast-tracked
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version
2.0 (TaqMan 96)
03121453001, 03051315001, 05212294190, 03587797190, 04862392001, 05807875001, 05527503001, 28127387001
Roche Molecular Systems
Inc.
Branchburg, NJ, USA
1-May-2012*fast-tracked
As of 20 July 2012• More information and WHO Public Reports can be found on the WHO website www.who.int/diagnostics_laboratory
AIDS2012 – WHO Satellite Session l 25 July 201216 |
PQ Dx progress: applications
Status as of 17 July 2012, based on analysis of PQ tracking document
38%
17%10%
6%
17%
9% 3%
Prioritized applications, by type
HIV rapid / other Malaria rapid CD4
HIV EIA HIV VL HCV
HBV
PQ applications– 152 applications received– 84 priority applications
accepted– 22 applications closed– 20 applications withdrawn
Remaining applications– Not for priority disease/ format – Multiple applications from
same Mx • with on-going quality concerns
AIDS2012 – WHO Satellite Session l 25 July 201217 |
PQ Dx progress: dossiers
67 dossiers screened for completeness
– 27 HIV RDT/EIA/other– 6 CD4 technologies– 11 HIV quantitative NAT
(viral load)– 2 HIV qualitative NAT– 6 HCV– 2 HBsAg– 11 malaria RDTs
All dossiers required amendments before full assessment
– Up to 4 rounds of amendments required
43 dossier assessments completed
– 11 dossiers still under full assessment
All dossiers required action plan after full assessment
AIDS2012 – WHO Satellite Session l 25 July 201218 |
PQ Dx progress: laboratory evaluations 13 HIV RDTs completed
– 8 RDTs on-going/scheduled– 4 EIAs on-going
5 CD4 technologies on-going– Results Q3-Q4 2012
HIV viral load on dried blood spots – Results Q4 2012
Malaria RDTs completed under WHO/TDR product testing programme
AIDS2012 – WHO Satellite Session l 25 July 201219 |
PQ Dx progress: site inspections
Conducted for 37 products (21 manufacturers)– 13 HIV RDTs– 8 HIV viral load technologies – 5 CD4 technologies– 11 malaria RDTs
8 products (4 manufacturers) have required re-inspection
15 products (6 manufacturers) scheduled for inspection in Q3/Q4 2012
AIDS2012 – WHO Satellite Session l 25 July 201220 |
PQ Dx progress
New dossiers requested
Dossiers received / screened
Dossiers under full review / full review com-
plete
New inspec-tions scheduled
/ requested
Inspections conducted
Inspection re-ports with
manufacturer
Lab evaluations in progress
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HIV rapids
Malaria
CD4
HCV All Formats
HIV virological tech.
HIV EIA
Status as of 17 July 2012
AIDS2012 – WHO Satellite Session l 25 July 201221 |
Time to PrequalificationFT vs non-FT
SD BIOLINE Malaria Ag P.f
IMMUNOQUICK Malaria Falciparum
Pima CD4 test
Alere Determine HIV-1/2
HIV 1/ 2 STAT-PAK® Dipstick
HIV 1/2 STAT-PAK®
Alere Determine HIV-1/2 Ag/Ab Combo
Abbott RealTime HIV-1 (m24sp)
Abbott RealTime HIV-1 (m2000sp)
Abbott RealTime HIV-1 (manual)
NucliSENS EasyQ® HIV-1 v2.0 (Automated)
NucliSENS EasyQ® HIV-1 v2.0 (Automated)
COBAS® AmpliPrep / COBAS® TaqMan® HIV-1 Test, version 2.0 (TaqMan 48)
COBAS® AmpliPrep / COBAS® TaqMan® HIV-1 Test, version 2.0 (TaqMan 96)
VERSANT™ HIV-1 RNA 1.0 Assay (kPCR)
Average
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Average AllPQ Time FTPQ Time non-FT
Working Days
AIDS2012 – WHO Satellite Session l 25 July 201222 |
Contents
Market share
WHO Prequalification of Diagnostics programme
Remaining challenges
Next steps
AIDS2012 – WHO Satellite Session l 25 July 201223 |
ChallengesMultiple regulatory versions for the "same" product
Variable stringency of regulatory review by NRAs– depends on risk classification – if product is for export-only, minimal review
Variable stringency of conformity assessment bodies/inspection agencies
– Some inspections may be outsourced to in-country agencies– Differences in QC lot release procedures for CE-marked
products for different notified bodies
AIDS2012 – WHO Satellite Session l 25 July 201224 |
Challenges
Still poor understanding and implementation of quality management systems at manufacturing site
Inadequate product dossier to demonstrate performance claims including
– Product stability • Both in-use and transportation stability
– QC and lot release procedure– Customer service in resource-limited settings
AIDS2012 – WHO Satellite Session l 25 July 201225 |
Contents
Market share
WHO Prequalification of Diagnostics programme
Remaining challenges
Next steps
AIDS2012 – WHO Satellite Session l 25 July 201226 |
Next steps
Amplifying post-market surveillance activities– Should be the onus of the manufacturer, but poorly executed– Role for global/national entities to collect data on poorly
performing products & feedback to Mx and other users
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
AIDS2012 – WHO Satellite Session l 25 July 201227 |
Next steps
Measure impact of prequalification on– Capacity of Mx to consistently produce good quality products – Market dynamics– Access to new innovative diagnostics
Extend prequalification to new product categories of public health value
– TB, HBsAg, HCV, HIV/syphilis, other multiplexed tests, etc. – male circumcision devices
AIDS2012 – WHO Satellite Session l 25 July 201228 |
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]