1. Global Strategy, Policy and Normative Guidance for POC Diagnostics Gottfried Hirnschall MD, MPH Department of HIV/AIDS, World Health Organization July 22, 2012 Presented at the Symposium: "The Decade of Diagnostics" - Catalyzing Markets to Accelerate Access to Point of Care Testing

2. "Universal Access" needs POC testing The international community has committed to: –Reach 15 million people living with HIV with ART by 2015 –Reduce sexual transmission by 50 % by 2015 –Eliminate new HIV infections among children This requires more and earlier ART ART is possible only if people can be diagnosed on time To maximize the impact of ART it needs to be monitored well  POC Technologies are needed for both – and they need to be simple, robust and affordable.

3. Access to diagnostics is part and parcel of WHO's Strategy The Global Health Sector Strategy on HIV/AIDS 2011-2015 The Treatment 2.0 Framework WHO normative and technical guidance

4. The Global Health Sector Strategy on HIV/AIDS 2011-2015 2 GOALS to achieve universal access to diagnosis, HIV prevention, treatment and care interventions for all in need to contribute to achieving health related MDGs and their associated targets by 2015. 4 STRATEGIC DIRECTIONS

5. The WHO/UNAIDS Treatment 2.0 Framework Achieve and sustain universal access & maximize the preventive benefits of ART The T2.0 Framework operationalizes the Global Health Sector Strategy on HIV/AIDS and re-energize the HIV Response under the Five pillars : I – Optimize drug regimens II – Promote diagnostics using point of care and other simplified technologies III – Reduce costs IV – Adapt delivery systems V – Mobilize communities, protect human rights TREATMENT 2.0 Adapt delivery systems Mobilize communities POC and other simplified monitoring Optimize drug regimens Reduce costs

6. WHO normative and technical guidance: Recent developments in HIV diagnostic technology 2 WHO Expert Consultations on HIV diagnosis, treatment initiation and monitoring technologies and approaches (October 2011, and June 2012) (with help from Pangaea and BMGF) WHO Diagnostics Prequalification program Normative work –On service delivery and testing algorithms –On procurement specifications, optimized deployment of lab technology, and market transparency (with help from UNITAID) –On revised recommendations on the use of diagnostics in the 2013 consolidated ART guidelines

7. WHO HIV Diagnostics Prequalification Status as of 16 July 2012 Viral load: 7 fast tracked 0 POC in pipeline 1 other in pipeline CD4: 1 prequalified 3 POC in pipeline 5 other in pipeline HIV test 2 prequalified 17 POC in pipeline 9 other in pipeline COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 48) Pima CD4 Test (25 and 100 cartridiges/kit and instrument) HIV 1/2 STAT-PAK® (20 and 30 tests/kit) COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 96) Alere Determine HIV-1/2 (20 and 100 tests/kit) VERSANT® HIV-1 RNA 1.0 Assay (kPCR) NucliSENS EasyQ® HIV-1 v2.0 (Automated) NucliSENS EasyQ® HIV-1 v2.0 (Semi-Automated) Abbott RealTime HIV-1 (Manual) Abbott RealTime HIV-1 (m2000sp) Abbott RealTime HIV-1 (m24sp)

8. HTC service delivery and testing algorithms

9. Procurement checklists and specificationsSupport lab procurement byprogram managersPartners:ASLM, CDC, CHAI, CHU LeDantec, Crown Agents, FIND,MSH, MSF, SCMS, UNICEF,USAID/Deliver Market transparency Improve Diagnostics content in Global Price Reporting Mechanism Assessment of cost to produce a lab result (different technologies, different settings) Partners: ANRS, CDC, Crown Agents, GFATM, FIND, SCMS, UNICEF, UNITAID

10. Some recommendations from WHO Expert consultations on diagnostics HIV serology testing: better RDTs, readers, combo HIV-syphilis and HIV-HBV rapid tests to be developed Deploy CD4 POC technologies at health center level now – bring development pipeline to market Use dried blood spots and central labs for EID testing and VL for now, develop POC technologies ASAP Develop IT for results communication and management of supply chains