Presentation at the IAS 2011 conference on 18 July 2011 by Maurine M. Murtagh, HIV Diagnostics Market Expert.

1. The HIV/AIDS Diagnostic Landscape: What does the Future Hold? Maurine M. Murtagh IAS 2011 Rome, Italy July 18, 2011

3. Funding availability has meant most rapid progress in HIV/AIDSMillions of patients identified and more than 6.6 million initiated on antiretroviral therapy

4. But, there is more work to be done. We would like to: SIMPLIFY TESTING IMPROVE ITS EFFICIENCY REDUCE ITS COST INCREASE OVERALL ACCESS TO DIAGNOSTICS BUT, NOT DIMINISH THE QUALITY OF PATIENT CARE

5. Diagnostics for HIV/AIDS is a Continuum of Testing Rapid Testing and EID ILLUSTRATIVE Need for Service CD4 Chemistry & Hematology CD4 and Viral Load Resistance Testing Chemistry & Hematology Safety Tests for ART Initiation Staging and Monitoring Monitoring 1st Line Monitoring 2nd Line Diagnosis Challenges at any one point can become bottlenecks for patients proceeding further through the HIV care and treatment program. These blockages prevent full realization of potential volumes for ARVs and other tests further downstream, which impacts program costs and also reduces the number of patients proceeding healthily into and through the ART program.

6. The Current HIV Diagnostic Market *1 test every 6 months for the ~6.6 million on ART + 6.6 million on care (CD4) or ~6.6 million on treatment (VL)

7. Factors Limiting Diagnostic Access Diagnostic delivery of EID, CD4 and viral load testing is generally via large and relatively expensive laboratory-based systems that require well-trained technicians and good sample transport networks to provide access to testing for those in some urban, and virtually all peri-urban and rural settings.

9. In some rural settings, up to 40% of patients who receive a positive HIV diagnosis do not receive the follow-up tests they need to help them initiate treatment and monitor disease progression.

10. Additionally, limited capacity at central labs often leads to long patient backlogs and waiting periods between tests.And, further . . . Solutions are Needed

11. New Diagnostic Technologies The diagnostic landscape is beginning to change and may change dramatically with the introduction of diagnostics designed to be delivered at or near the patient point of care (POC). For the first time, we will have the opportunity to deliver EID, CD4 and viral load testing on site in peri-urban and rural settings.

13. Reduce/eliminate the need for service and maintenance

14. Reduce the per test cost of testing

15. Yield same day results for prompt clinical decision-making

16. Improve patient retention

19. At least one on pace to launch in late 2011, early 2012

20. More expected to follow in 2013EID Only: At least 2 dedicated POC technologies for EID expected by 2013

21. CD4 Product Pipeline* BD Zyomyx PIMA PointCare Burnet Daktari Partec Mini mBio 2009 2010 2011 2013 2012 Instruments Disposable *Estimated - timeline and sequence may change

22. Technology Pipeline – Viral Load and EID* Micronics Liat WAVE 80 EOSCAPE ALL Alere NWGHF EID SAMBA EID SAMBA VL Biohelix NWGHF VL Gene XPert 2015 2014 2013 2011 2012

25. Acknowledgments UNITAID Dr. Trevor Francis Peter Advanced Liquid Logic, Alere, BD Biosciences, Biohelix Burnet, Cepheid, Daktari Diagnostics, Diagnostics for the Real World, Iquum, Micronics, Northwestern Global Health Foundation, Partec, PointCare, WAVE80, and Zyomyx

26. Thank you

27. Extra Slides

29. CD4: BD, Coulter

30. Viral Load: Roche, Abbott, Siemens, bioMérieux

31. EID: Roche, Abbott

32. Hard to quantify market due to incomplete reporting, but in 2010 approximate market was:

33. CD4 - ~14 million tests

34. Viral Load - ~2.5 million tests (dominated by RSA and Brazil)

35. EID - ~600,000 tests

36. Based on projected number of patients in care and on treatment, the market for each test category is expected to grow over the next 5 years.