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The HIV/AIDS Diagnostic Landscape: What does the Future Hold?
 

The HIV/AIDS Diagnostic Landscape: What does the Future Hold?

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

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

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    The HIV/AIDS Diagnostic Landscape: What does the Future Hold? The HIV/AIDS Diagnostic Landscape: What does the Future Hold? Presentation Transcript

    • The HIV/AIDS Diagnostic Landscape: What does the Future Hold?
      Maurine M. Murtagh
      IAS 2011
      Rome, Italy
      July 18, 2011
    • Access to diagnostics for the HIV patient in resource-limited settings has improved through collaborative efforts
      • Governments and partners have scaled up testing services
      • Funding availability has meant most rapid progress in HIV/AIDS
      Millions of patients identified and more than 6.6 million initiated on antiretroviral therapy
    • 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
    • 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.
    • 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)
    • 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.
      • Even for patients who do have reliable access to testing, they often make multiple visits to health facilities to obtain a single test result, with the loss of travel costs and man-hours.
      • 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.
      • Additionally, limited capacity at central labs often leads to long patient backlogs and waiting periods between tests.
      And, further . . .
      Solutions are Needed
    • 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.
    • The Promise of POC Testing
      POC testing has the promise to:
      • Reduce the need for large infrastructure investments in diagnostic equipment
      • Reduce/eliminate the need for service and maintenance
      • Reduce the per test cost of testing
      • Yield same day results for prompt clinical decision-making
      • Improve patient retention
      • Reduce the need for sample transport network
    • The POC Diagnostic Pipeline
      CD4 is the farthest along:
      • Currently 3 POC or near POC devices on the market
      • Several more to come, at least one of which will be disposable
      Viral Load and EID:
      • No POC devices currently on the market
      • At least one on pace to launch in late 2011, early 2012
      • More expected to follow in 2013
      EID Only:
      At least 2 dedicated POC technologies for EID expected by 2013
    • 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
    • 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
    • The Limitations of POC Testing
      POC testing has the promise to fill gaps in access and capacity, and there are some exciting POC diagnostics either here or coming over the next few years. But, there is no silver bullet technology yet.
      Understanding the realistic value and preparing for the implementation challenges is imperative to increase access to the right populations in the right way.
      POC Testing:
      • Is generally low throughput testing and may not be cost-effective in high- to medium-throughput settings
      • Does not eliminate the need to improve/strengthen lab systems, including HR/Training, Supply Chain, Service Delivery Design and Quality Assurance
    • If the goal for diagnostics going forward is robust, high-quality, efficient, cost-effective and accessible diagnostic services for the full complement of testing required to diagnose, stage and monitor the HIV patient effectively, this will require continued use of both centralized and POC testing for the foreseeable future.
      Implications for UNITAID Funding
      For countries where high throughput testing is required to provide improved access, there will likely be an increasing concentration of centralized testing facilities, including super labs.
      But, there are also opportunities to improve access and to lower the cost of CD4, viral load and EID with the strategic introduction of POC and near POC devices and tests.
    • 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
    • Thank you
    • Extra Slides
    • The Current Market for CD4, Viral Load and EID
      • Except for rapid testing, each of the HIV test markets is dominated by a few suppliers of laboratory-based platforms:
      • CD4: BD, Coulter
      • Viral Load: Roche, Abbott, Siemens, bioMérieux
      • EID: Roche, Abbott
      • Hard to quantify market due to incomplete reporting, but in 2010 approximate market was:
      • CD4 - ~14 million tests
      • Viral Load - ~2.5 million tests (dominated by RSA and Brazil)
      • EID - ~600,000 tests
      • 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.