1. Use of POC technologies for
early diagnosis of HIV
Francesca Celletti

2. What is innovation?
Innovation is not only development of a product. It has to bring better values for clients and return from investments. The nature of the innovation should be of definable value, introduce a concrete change and bring about a related and measurable outcome
What is missing here is what bring better life to people – better life is earlsy diahnos, early treatment and quality of treatment
The world needs innovation on HIV and particularly on diagnostic to detect HIV early. The facts are telling.

3. Progress toward the target
Progress is promising. But we can see that the hardest 90 is the first. It is clear that better diagnostics are the solution. However, today we are here to talk about technological innovations, but the solutions to this issues is also programmatic.

4. Gaps in current early infant diagnosis cascade
Challenge 1: Poor access to and delays in EID testing
51% of 1.2 million HIV-exposed African children had access to EID testing in 2014
Most HIV-exposed infants receive their first test at age 6 months or later (WHO recommends first test at 6 weeks)
Challenge 2: Delays or no return of test results
Median time of 30 to 90 days from sample to delivery of results
Only 50% of children who are tested receive their test results
Challenge 3: Poor initiation of HIV-positive infants on treatment
SA study: 10 week delay between diagnosis and initiation of treatment
Kenya study: 44% of HIV- positive infants never reached ART clinic
51%
50%
Why do we need innovation?
Can innovation improve prgrams> We need innovation that is close to hwer eteh business is. Hence the concepat of POC
8.9%
51%
Source: On the Fast-Track to an AIDS-Free Generation, UNAIDS, 2016

5. Source: HIV/AIDS Diagnostics Technology Landscape, UNITAID, 2015
POC NAT pipeline
ZIVA™
Cavidi
2015
2014
2016
SAMBA II EID
DRW
Kenya, Ugand, CE Markeda
Alere™ q HIV-1/2 Detect
Alere
CE Mark
Xpert® HIV-1 Qual
Cepheid
LYNX HIV p24
NWGHF
Micronics
Iquum/Roche
Lumora
Under development
QuantumDx
Ustar
DFA
TaqMan® HIV-1 Qual v2.0
Roche
DBS CE Mark
RealTime Qual HIV-1
Abbott
DBS CE Mark (2011)
SAMBA I Semi-Q EID
Kenya, Uganda
* Reported November timeline and sequence may change
no specific market launch date; DBS assay CE Mark noted for laboratory products
** In addition, open polyvalent platforms are currently available for HIV VL and EID testing
GeneXpert
Omni
Cepheid
Which innovation do we have?
We need to be clear – it is different from what promised to us. Innovation we need to bold and blunt – there is a plan, an idea, but the results is different. There is a wastage, there might high risk – we need to facore that in in the programs and when intrdoucong innovation.
Also, this is a presentation that focuses on the technology – but there is ino innavtion that is introduced to make a concrete
Source: HIV/AIDS Diagnostics Technology Landscape, UNITAID, 2015 5

6. EGPAF/UNITAID POC EID project
Goal: to increase the number of HIV-exposed infants whose HIV status is known and facilitate early initiation on treatment.
Scale:
9 countries
4 years (2015 – 2019)
$63 million
Targets:
320,000 infants
13,562 HIV+ (4.2%)
Results within 2 day
EID coverage 20%
ART initiation by 14 days
Market shaping for POC
To illustrate my statement, let me use as acase study the partnership with UNITAID.
We have been in pediatric HIV for many years. We were failing to test and test eraly. It was clear to us the conevntioanl EID was not imotima. The program raised the need.
How do we use it?

7. How is a product introduced and brought to scale in countries?
R&D
Entry into market
Fit to needs
Pre-qualification
Pricing/negotiation
Global forecasting
In-country registration
Fit for purpose
Quality assurance
Post-market surveillance
Placement and delivery system
Generation of demand
Increase access
Health workers training and acceptability
Ensuring a market share
UNITAID, 2016
Hence the partnership with UNITAID whose focus is to invest in innovation. The products has been in the market. Pre-Q came. We are now atrting implementation with the pilot in September.
Impact and C/E evaluation
Generation of new evidence
Scalability
Sustainability

8. Source: HIV/AIDS Diagnostics Technology Landscape, UNITAID, 2015
POC NAT pipeline
ZIVA™
Cavidi
2015
2014
2016
SAMBA II EID
DRW
Kenya, Uganda
Alere™ q HIV-1/2 Detect
Alere
CE Mark
Xpert® HIV-1 Qual
Cepheid
LYNX HIV p24
NWGHF
Micronics
Iquum/Roche
Lumora
Under development
QuantumDx
Ustar
DFA
TaqMan® HIV-1 Qual v2.0
Roche
DBS CE Mark
RealTime Qual HIV-1
Abbott
DBS CE Mark (2011)
SAMBA I Semi-Q EID
* Reported November timeline and sequence may change
no specific market launch date; DBS assay CE Mark noted for laboratory products
** In addition, open polyvalent platforms are currently available for HIV VL and EID testing
GeneXpert
Omni
Cepheid
We have a product – can this meet other needs?
Source: HIV/AIDS Diagnostics Technology Landscape, UNITAID, 2015 8

9. Acute HIV infection
AHI is primary stage, develops 2-4 weeks after infection
RDTs miss this stage
Population impact
5-50% of ongoing sexual transmission
Up to 64% of vertical transmission
Individual impact
Intervention during AHI reduces viral set point
Improved clinical outcomes (e.g. VISCONTI cohort)
Key populations
Pregnant women
Older adolescent women
Commercial sex workers
Before initiating on PrEP
Shanks PLoS One 2013; 2. Klarkowski PLoS One 2009; WHO 2015

10. National Testing Policies in Line with WHO Recommendations
HIV infection Misdiagnosis
Category # %
Clerical/technical errors (e.g. mis-labelling, poor recordkeeping, clerical mistakes) 14
32%
User error (e.g. errors performing RDT or interpreting results, misapplication of buffer, inaccurate reading time and other human errors) 11
48%
Cross-reactivity (e.g. antibodies from inter-current infection, environmental exposure to test components, HIV subtype, or late-stage AIDS) 8
18%
Incorrect / suboptimal testing strategy or algorithm (e.g. tiebreaker testing strategy) 22
50%
Poor management and supervision (work load stress, staff shortages, lack of training, poor adherence to testing strategy or testing algorithm, substandard operating procedures, testing in window period) 20
45%
National Testing Policies in Line with WHO Recommendations
48 Countries
Review identified reports of misclassification range from 2.6% to 10.3%1,2
WHO 2015

11. Thank you