1. Deputy Executive Director
Top HIV diagnostics for small labs in Africa
Philippe Duneton
Deputy Executive Director
17 June 2013

2. Long term goal of the Global Health Community
HIV/AIDS
GOAL: Reaching 15 million people with ARVs by 2015
WHO New 2013 Guidelines
CD4: 500 cells/mm3 from 350
FDCs – 1 pill a day (Tenofovir based)
Patient monitoring

3. Low access to HIV treatment: Only 9 million of 25 million people in need are now on ART1
Previous target of Universal access set up in 2011 (and defined as 80% of those in need), was to reach 15 Million by year 2015.
The number of people considered eligible for ART will increase approx. to 25 million with revised criteria (CD4 Threshold) for ART initiation and the addition of the groups already considered independent of CD4 such as all pregnant women and breastfeeding women (previously called Option B plus), children under five years old, HIV-positive partners in serodiscordant couples, and people with HIV and active TB disease or severe chronic liver disease and Hepatitis B ).
The challenge of reaching an additional 16 million people in need of treatment is compounded by the fact that a proportion of those currently on ART are receiving suboptimal treatment including d4T-containing regimens (estimates up to 20-30% of those on 1st line ART) .

4. Monitoring diagnostics CD4 Viral Load Early Infant Diagnostics
Large modern laboratories
Sophisticated equipment
Highly trained staff
Benefit: High volume
4,500 tests a months
Samples need to be transported
Result returned to patient
Nyumbani, Karen, Kenya
Pediatric University Hospital, Lusaka, Zambia

5. The reality of low resource settings
Limitation in health infrastructure
Crowded facilities
Basic laboratory facilities
Irregular power and water supply
Limitation in human resources
Few doctors
Health workers with limited training carry out most consultations
District Hospital, Meconta, Mozambique
Quality, simple to use
diagnostic and medicines are needed to assure rapid effective treatment
Kiboga Referral Hospital, Uganda

6. Point of care testing Small devices
Easy to use outside central laboratories
Rapid results
Back up power supply
HIV patient monitoring
CD4
Viral Load
Early Infant Diagnosis
1er maio, Maputo
Mozambique

7. Benefits to Patients Ideal for resource limited settings
– both urban and rural
Decreases turn-around time – results available on same day
Improves patient outcomes – prompt treatment
Reduces loss to follow up – no need to return for results
Reduces workload of the central laboratory
Phebe Hospital, Liberia

8. UNITAID's new Point of Care Projects
CHAI/UNICEF
Medecin Sans Frontiere
FEI –OPP-ERA
London School of Hygiene and Tropical Medicines
AIM: Increase CD4 testing to 80% and Viral load testing to 50% in low income countries
Good monitoring of patients =
better care and treatment

9. PointCare Technologies
CD4 Product Pipeline*
BD FACSPresto™
BD Biosciences
Pima™ Analyser
Alere
PointCount NOW™
PointCare Technologies
Visitect® CD4
Omega/Burnet
Zyomyx
CD4 Test
MBio CD4 System
CyFlow® CD4 miniPOC
Partec
Daktari™
CD4 Counter
2009
2010
2013
2014
Disposable
Disposable
Instruments
Instruments
*Estimated as of March timeline and sequence may change. 9

10. EOSCAPE HIV™ Rapid RNA Assay System LYNX Viral Load Platform
Viral Load and EID Product Pipeline*
Liat™ Analyser
IQuum
Alere Q
Alere
EOSCAPE HIV™ Rapid RNA Assay System
Wave 80 Biosciences
RT CPA HIV-1 Viral Load Ustar
LYNX Viral Load Platform
NWGHF
Micronics
Gene-RADAR®
Nanobiosym
SAMBA VL
DDU/Cambridge
ALL
Cavidi AMP
Gene Xpert® System
Cepheid
LYNX HIV p24 Antigen
NWGHF
Truelab™ PCR
Molbio/bigTec
Viral Load Assay with BART Lumora
BioHelix
SAMBA EID
DDU/Cambridge
2013
2014
2015
2016
*Estimated as of March timeline and sequence may change No market launch date set by company. 10

11. Call for LOIs
UNITAID is pleased to announce the first Call for Letters of Intent (LOI) of its new strategic period
Deadline: 22 Sep 2013