Current pipeline for WHO PQ of Diagnostics programme

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


Contents

Market share

WHO Prequalification of Diagnostics programme

Remaining challenges

Next steps


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


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)


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)


Contents

Market share



Next steps


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


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 /


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


Recent progress

1 Products prequalified in 2010



Further 5-10 Products anticipated for prequalification in 2012

22 Products closed

20 Products withdrawn



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)



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



WHO prequalified products (malaria RDTs)



WHO prequalified products (CD4 technologies)


Pima CD4 Test 260100100 and 260300001 Alere Technologies GmbH Jena, Germany 25-Nov-11

*conditional



WHO prequalified products (HIV viral load technologies)


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


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



WHO prequalified products (HIV viral load technologies)


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



PQ Dx progress: applications


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


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


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


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


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

0tan28a566028

0tan9a56609

0tan19a566019

0tan29a566029

0tan9a56609

0tan19a566019

0tan29a566029

0tan9a56609

HIV rapids

Malaria

CD4

HCV All Formats

HIV virological tech.

HIV EIA

Status as of 17 July 2012


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 (manual)



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

0tan28a566028 0tan21a566021 0tan14a566114 0tan7a566170tan1a56601

0tan23a566023

0tan4a56614

0tan4a56614

0tan7a56617

0tan13a566113

0tan21a566121

17tan22a566122

0tan29a566029

0tan29a566029

0tan29a566029

0tan7a56607

0tan10a566010

0tan30a566130

0tan30a566130

0tan6a56616

0tan6a566160tan12a566112

Average AllPQ Time FTPQ Time non-FT

Working Days


Contents

Market share



Next steps


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


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


Contents

Market share



Next steps


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


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


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]

Current pipeline for WHO PQ of Diagnostics programme

Documents

Transcript of Current pipeline for WHO PQ of Diagnostics programme