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 Sands
Diagnostics & Laboratory Technology
Department of Essential Medicines & Health Products
1 | AIDS2012 – WHO Satellite Session l 25 July 2012
Contents
 Market share
 WHO Prequalification of Diagnostics programme
 Remaining challenges
 Next steps
2 | AIDS2012 – WHO Satellite Session l 25 July 2012
Global market for diagnostics
Volume of Procurement (number of tests)
70,000,000
60,000,000
Number of Tests
50,000,000
40,000,000
30,000,000
20,000,000
10,000,000
0
2008
2009
2010
2011
Total HIV Test Procurement by WHO and UNICEF
11,894,207
1,638,546
14,488,526
19,002,435
Total HIV test Procurement (WHO, UNICEF, SCMS,
UNITAID, GFATM)
43,945,556
51,018,650
44,310,219
63,663,555
Value of procurement (USD)
HIV Test Procurement by WHO and UNICEF
Total Value of Procurement HIV Tests
2008
12,824,052
37,330,367
Based on available data from SCMS, UNICEF, WHO, UNITAID (when available) and GFATM
3 | AIDS2012 – WHO Satellite Session l 25 July 2012
2009
11,973,368
36,759,746
2010
18,021,498
38,142,075
2011
21,681,040
58,068,300
2008 HIV RDTs Market Share by Volume
Determine™ HIV-1/2
3.609%
.00%
Uni-Gold™ HIV
15.587%
SD BIOLINE HIV 1/2 3.0
5.827%
First Response® HIV 1-2-0 Card
Test
3.897%
56.559%
7.095%
7.425%
HIV 1/2 STAT-PAK®
Diagnostic Kit for HIV (1+2)
Antibody (Colloidal Gold)
DoubleCheckGold™ HIV1&2
Whole Blood
Other (32 tests)
4 | AIDS2012 – WHO Satellite Session l 25 July 2012
2010 HIV RDTs Market Share by Volume
1.042%
.106%
.481%
Determine™ HIV-1/2
.041%
3.510%
Uni-Gold™ HIV
5.468%
5.596%
SD BIOLINE HIV 1/2 3.0
First Response® HIV 1-2-0 Card
Test
HIV 1/2 STAT-PAK®
Diagnostic Kit for HIV (1+2)
Antibody (Colloidal Gold)
83.756%
DoubleCheckGold™ HIV1&2 Whole
Blood
Other (32 tests)
5 | AIDS2012 – WHO Satellite Session l 25 July 2012
Contents
 Market share
 WHO Prequalification of Diagnostics programme
 Remaining challenges
 Next steps
6 | AIDS2012 – WHO Satellite Session l 25 July 2012
Aim of WHO Prequalification of Diagnostics
 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
7 | AIDS2012 – WHO Satellite Session l 25 July 2012
WHO Prequalification of Diagnostics
Application by Manufacturer
Dossier
Assessment
Manufacturing
Site Inspection
Laboratory
Evaluation
Meets
Requirements
Product Prequalified
Post Market Surveillance
See WHO website for more details http://www.who.int/diagnostics_laboratory/evaluations/en/
8 | AIDS2012 – WHO Satellite Session l 25 July 2012
PQ Dx applications received
Test format
EIA
Rapid
Tests
CD4
Technologies
Virological
Technologies
Other
Total
HIV
9
43
9
14
5
80
HIV/HCV
0
1
0
1
HIV/syphilis
0
1
0
1
HCV
8
10
1
19
HBV
6
8
0
14
Malaria
2
35
0
37
Total
25
96
6
152
Analyte
Status as of 20 July 2012, based on analysis of PQ tracking document
9 | AIDS2012 – WHO Satellite Session l 25 July 2012
N/A
9
0
14
Recent progress
Products prequalified in 2010
1
Products prequalified in 2011
13
Products prequalified in 2012
5
Products anticipated for prequalification in 2012 Further 5-10
Products closed
22
Products withdrawn
20
Status as of 20 July 2012, based on analysis of PQ tracking document
10 | AIDS2012 – WHO Satellite Session l 25 July 2012
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
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
Alere Determine HIV-1/2
 In addition, list of products eligible for WHO
procurement still stands until sufficient number of
prequalified products (all have submitted for PQDx)
As of 20 July 2012
•More information and WHO Public Reports can be found on the WHO website www.who.int/diagnostics_laboratory
11 | AIDS2012 – WHO Satellite Session l 25 July 2012
WHO prequalified products (malaria RDTs)
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
As of 20 July 2012
•More information and WHO Public Reports can be found on the WHO website www.who.int/diagnostics_laboratory
12 | AIDS2012 – WHO Satellite Session l 25 July 2012
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
13 | AIDS2012 – WHO Satellite Session l 25 July 2012
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, 04J7024, 04J71-93
Abbott 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, 04J7024, 04J71-93, 9K14-02
Abbott 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, 9K1501, 04J70-24, 04J71-93
Abbott 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, 285033
bioMérieux
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
14 | AIDS2012 – WHO Satellite Session l 25 July 2012
WHO prequalified products
(HIV viral load technologies)
Manufacturer
Manufacturing
site(s)
Product name
Catalogue number(s)
VERSANT® HIV-1 RNA 1.0
Assay (kPCR)
10375763, 10375764,
104801677, 04801685, 10467524
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
Siemens Healthcare
Tarrytown NY, USA
Diagnostics
As of 20 July 2012
•More information and WHO Public Reports can be found on the WHO website www.who.int/diagnostics_laboratory
15 | AIDS2012 – WHO Satellite Session l 25 July 2012
Date prequalified
13-Feb-12
*fast-tracked
PQ Dx progress: applications
 PQ applications
Prioritized applications, by type
9%
3%
38%
17%
– 152 applications received
– 84 priority applications
accepted
– 22 applications closed
– 20 applications withdrawn
 Remaining applications
6%
10%
17%
HIV rapid / other
Malaria rapid
CD4
HIV EIA
HIV VL
HCV
HBV
Status as of 17 July 2012, based on analysis of PQ tracking document
16 | AIDS2012 – WHO Satellite Session l 25 July 2012
– Not for priority disease/ format
– Multiple applications from
same Mx
• with on-going quality concerns
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
17 | AIDS2012 – WHO Satellite Session l 25 July 2012
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
18 | AIDS2012 – WHO Satellite Session l 25 July 2012
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
19 | AIDS2012 – WHO Satellite Session l 25 July 2012
PQ Dx progress
70
HIV rapids
60
Malaria
50
CD4
40
30
HCV All Formats
20
HIV virological
tech.
10
0
HIV EIA
New dossiers
requested
Dossiers
received /
screened
Dossiers under
full review / full
review complete
Status as of 17 July 2012
20 | AIDS2012 – WHO Satellite Session l 25 July 2012
New
inspections
scheduled /
requested
Inspections
conducted
Inspection Lab evaluations
reports with
in progress
manufacturer
Time to Prequalification
FT vs non-FT
309.333
273.875
349.857
Average
VERSANT™ HIV-1 RNA 1.0 Assay (kPCR)
333
COBAS® AmpliPrep / COBAS® TaqMan® HIV-1 Test, version 2.0…
327
COBAS® AmpliPrep / COBAS® TaqMan® HIV-1 Test, version 2.0…
327
NucliSENS EasyQ® HIV-1 v2.0 (Automated)
248
NucliSENS EasyQ® HIV-1 v2.0 (Automated)
245
Abbott RealTime HIV-1 (manual)
237
Abbott RealTime HIV-1 (m2000sp)
237
Abbott RealTime HIV-1 (m24sp)
237
Average All
PQ Time FT
Alere Determine HIV-1/2 Ag/Ab Combo
466
HIV 1/2 STAT-PAK®
429
HIV 1/ 2 STAT-PAK® Dipstick
393
Alere Determine HIV-1/2
390
Pima CD4 test
390
IMMUNOQUICK Malaria Falciparum
231
SD BIOLINE Malaria Ag P.f
150
0
50
100
150
200
250
300
Working Days
21 | AIDS2012 – WHO Satellite Session l 25 July 2012
350
400
450
500
PQ Time non-FT
Contents
 Market share
 WHO Prequalification of Diagnostics programme
 Remaining challenges
 Next steps
22 | AIDS2012 – WHO Satellite Session l 25 July 2012
Challenges
 Multiple 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
23 | AIDS2012 – WHO Satellite Session l 25 July 2012
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
24 | AIDS2012 – WHO Satellite Session l 25 July 2012
Contents
 Market share
 WHO Prequalification of Diagnostics programme
 Remaining challenges
 Next steps
25 | AIDS2012 – WHO Satellite Session l 25 July 2012
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
26 | AIDS2012 – WHO Satellite Session l 25 July 2012
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
27 | AIDS2012 – WHO Satellite Session l 25 July 2012
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
www.who.int/diagnostics_laboratory
direct mail & posted on the
WHO website
Email: diagnostics@who.int
Thank you
28 | AIDS2012 – WHO Satellite Session l 25 July 2012