1. AIDS2012 – WHO Satellite Session l 25 July 2012 1 |1 | Current pipeline for WHO PQ of Diagnostics programme 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 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

2. AIDS2012 – WHO Satellite Session l 25 July 2012 2 |2 | Contents Market share WHO Prequalification of Diagnostics programme Remaining challenges Next steps

3. AIDS2012 – WHO Satellite Session l 25 July 2012 3 |3 | Global market for diagnostics 2008200920102011 HIV Test Procurement by WHO and UNICEF12,824,05211,973,36818,021,49821,681,040 Total Value of Procurement HIV Tests37,330,36736,759,74638,142,07558,068,300 Value of procurement (USD) Based on available data from SCMS, UNICEF, WHO, UNITAID (when available) and GFATM

4. AIDS2012 – WHO Satellite Session l 25 July 2012 4 |4 | 2008 HIV RDTs Market Share by Volume

5. AIDS2012 – WHO Satellite Session l 25 July 2012 5 |5 | 2010 HIV RDTs Market Share by Volume

6. AIDS2012 – WHO Satellite Session l 25 July 2012 6 |6 | Contents Market share WHO Prequalification of Diagnostics programme Remaining challenges Next steps

7. AIDS2012 – WHO Satellite Session l 25 July 2012 7 |7 | 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

8. AIDS2012 – WHO Satellite Session l 25 July 2012 8 |8 | WHO Prequalification of Diagnostics Application by Manufacturer Meets Requirements Dossier Assessment Manufacturing Site Inspection Laboratory Evaluation Product Prequalified Post Market Surveillance See WHO website for more details http://www.who.int/diagnostics_laboratory/evaluations/en/

9. AIDS2012 – WHO Satellite Session l 25 July 2012 9 |9 | PQ Dx applications received Status as of 20 July 2012, based on analysis of PQ tracking document Total Other Virological Technologies CD4 Technologies Rapid Tests EIA 805149439HIV 10 0N/A 10HIV/HCV 1010HIV/syphilis 191108HCV 14086HBV 370352Malaria 15261499625Total Test format Analyte

10. AIDS2012 – WHO Satellite Session l 25 July 2012 10 | Recent progress 1Products prequalified in 2010 13Products prequalified in 2011 5Products prequalified in 2012 Further 5-10Products anticipated for prequalification in 2012 22Products closed 20Products withdrawn Status as of 20 July 2012, based on analysis of PQ tracking document

11. AIDS2012 – WHO Satellite Session l 25 July 2012 11 | WHO prequalified products (HIV RDTs) Product nameCatalogue number(s)ManufacturerManufacturing site(s)Date prequalified Alere Determine HIV-1/27D2342Alere Medical Co. Ltd. Matsudo-shi, Chiba-ken, Japan 25-Nov-11 Alere Determine HIV-1/2 7D2343Alere Medical Co. Ltd Matsudo-shi, Chiba-ken, Japan 25-Nov-11 Alere Determine HIV-1/2 Ag/Ab Combo 7D2643 and 7D2243Alere Medical Co. Ltd Matsudo-shi, Chiba-ken, Japan 19-Mar-12 HIV 1/2 STAT-PAK® DipstickHIV303 Chembio Diagnostic Systems Inc. Medford, NY, USA25-Nov-11 HIV 1/2 STAT-PAK®HIV101 Chembio Diagnostic Systems Inc. Medford, NY, USA16-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)

12. AIDS2012 – WHO Satellite Session l 25 July 2012 12 | Product nameCatalogue number(s)ManufacturerManufacturing site(s)Date prequalified SD BIOLINE Malaria Ag P.f05FK50 Standard Diagnostics, Inc. Giheung-gu, Republic of Korea 06-Dec-10 *Notice of Concern SD BIOLINE Malaria Ag P.f05FK53 Standard Diagnostics, Inc. Giheung-gu, Republic of Korea 06-Dec-10 *Notice of Concern IMMUNOQUICK® Malaria Falciparum 0502_K100BiosynexStrasbourg, France18-Oct-11 IMMUNOQUICK® Malaria Falciparum 0502_K50BiosynexStrasbourg, France18-Oct-11 IMMUNOQUICK® Malaria Falciparum 0502_K25BiosynexStrasbourg, France18-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

13. AIDS2012 – WHO Satellite Session l 25 July 2012 13 | WHO prequalified products (CD4 technologies) Product nameCatalogue number(s)Manufacturer Manufacturing site(s) Date prequalified Pima CD4 Test260100100 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

14. AIDS2012 – WHO Satellite Session l 25 July 2012 14 | WHO prequalified products (HIV viral load technologies) Product nameCatalogue 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, 04J71-93 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, 04J70- 24, 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, 9K15- 01, 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

15. AIDS2012 – WHO Satellite Session l 25 July 2012 15 | WHO prequalified products (HIV viral load technologies) Product nameCatalogue 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

16. AIDS2012 – WHO Satellite Session l 25 July 2012 16 | PQ Dx progress: applications Status as of 17 July 2012, based on analysis of PQ tracking document 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

17. AIDS2012 – WHO Satellite Session l 25 July 2012 17 | 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

18. AIDS2012 – WHO Satellite Session l 25 July 2012 18 | 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

19. AIDS2012 – WHO Satellite Session l 25 July 2012 19 | 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

20. AIDS2012 – WHO Satellite Session l 25 July 2012 20 | PQ Dx progress Status as of 17 July 2012

21. AIDS2012 – WHO Satellite Session l 25 July 2012 21 | Time to Prequalification FT vs non-FT

22. AIDS2012 – WHO Satellite Session l 25 July 2012 22 | Contents Market share WHO Prequalification of Diagnostics programme Remaining challenges Next steps

23. AIDS2012 – WHO Satellite Session l 25 July 2012 23 | 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

24. AIDS2012 – WHO Satellite Session l 25 July 2012 24 | 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

25. AIDS2012 – WHO Satellite Session l 25 July 2012 25 | Contents Market share WHO Prequalification of Diagnostics programme Remaining challenges Next steps

26. AIDS2012 – WHO Satellite Session l 25 July 2012 26 | 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

27. AIDS2012 – WHO Satellite Session l 25 July 2012 27 | 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

28. AIDS2012 – WHO Satellite Session l 25 July 2012 28 | 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: diagnostics@who.int