Transcript Slide 1

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
16
Annual CD4 Test
Volumes
14
Global ART
12
Cumulative
Global Fund Disbursements (USD Billions),
In Care
(LMIC only)
Year end 2009
10
• Funding availability has
meant most rapid progress
in HIV/AIDS
8
6
6
5.7
5
4
4
2
2.8
3
2
1.4
1
0
0
2005
2006
HIV
2007 TB
2008
2009
Malaria
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
Need for Service
ILLUSTRATIVE
Rapid
Testing
and
EID
CD4
Chemistry &
Hematology
CD4
and
Viral Load
Resistance
Testing
Chemistry & Hematology
Diagnosis
Staging and
Monitoring
Safety Tests
for ART
Initiation
Monitoring
1st Line
Monitoring
2nd Line
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 periurban and rural settings.
And, further . . .
• 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.
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
PointCare
Zyomyx
PIMA
Burnet
Daktari
Partec Mini
2009
mBio
2010
2011
Instruments
*Estimated - timeline and sequence may change
2012
2013
Disposable
Technology Pipeline – Viral Load and EID*
Liat
Micronics
WAVE 80
EOSCAPE
ALL
Alere
NWGHF EID
SAMBA EID
SAMBA VL
NWGHF VL
2011
2012
2013
Biohelix
Gene
XPert
2014
2015
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
Implications for UNITAID Funding
If the goal for diagnostics going forward is robust, high-quality, efficient, costeffective 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.
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.