Type of Review: Annual Review
Project Title: Foundation for Innovative Diagnostics (FIND)
2009-14
Date started: 11/2009 Date review undertaken: October 2012
Instructions to help complete this template:
Before commencing the annual review you should have to hand:
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the Business Case or earlier project documentation.
the Logframe
the detailed guidance (How to Note)- Reviewing and Scoring Projects
the most recent annual review (where appropriate) and other related monitoring reports
key data from ARIES, including the risk rating
the separate project scoring calculation sheet (pending access to ARIES)
You should assess and rate the individual outputs using the following rating scale and
description. ARIES and the separate project scoring calculation sheet will calculate the overall
output score taking account of the weightings and individual outputs scores:
Description
Outputs substantially exceeded expectation
Outputs moderately exceeded expectation
Outputs met expectation
Outputs moderately did not meet expectation
Outputs substantially did not meet expectation
Scale
A++
A+
A
B
C
Introduction and Context
What support is the UK providing?
DFID is providing the Foundation for Innovative Diagnostics (FIND) with £6.5 million from
2009-2014 to support the development of diagnostics for a number of neglected diseases of
poverty. Providing funding through a Product Development Partnership engages privatesector collaborators to apply their development, manufacturing and distribution strengths and
expertise to innovative technologies that would not be a private-sector priority, to achieve
maximum sustainable benefit for public health in developing countries.
The core diseases covered by FIND’s portfolio are malaria, tuberculosis (TB) and sleeping
sickness (human African trypanosomiasis); but they also work on developing diagnostics for
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non-malarial fevers, visceral leishmaniasis (which causes swelling of the liver and spleen,
fever and painful skin lesions), trachoma (a leading cause of preventable blindness), Chagas
disease and HIV. Alongside product development, FIND supports the development and
strengthening of laboratory facilities in disease endemic countries, in order to facilitate the
rapid uptake of new tools.
What are the expected results?
FIND’s goal is to contribute to a world where patients have equitable access to high quality
diagnostics. Its purpose is to drive the development and implementation of accurate and
affordable diagnostic tests that are appropriate to patient care in low-resource settings.
Expected results include:
1. Development of new Point of Care (POC) diagnostics and improved quality of existing
POC tests for use at community level;
2. Extension of existing technologies for use in the diagnosis of multiple rather than single
diseases, i.e. as diagnostic platforms rather than disease-specific tests;
3. Expansion of activities so that the programme portfolios include new disease areas such
as HIV and neglected diseases (where possible building upon the platforms approach);
and
4. Increased use of FIND diagnostics for disease testing amongst poor people in endemic
countries once the tests have received WHO endorsement.
What is the context in which UK support is provided?
There are few existing technologies such as diagnostics, drugs and vaccines to identify, treat
or prevent neglected diseases that affect the world’s poorest populations. Where they exist the
technologies are either too expensive, require high levels of infrastructure (e.g. constant
electrical supply, sterile equipment etc.) and high levels of staff training which are not available
in settings with weak health systems. For diagnostics there is a need for “point of care” tests
that allow for immediate diagnosis, without the need for expensive laboratory infrastructure
and skilled staff able to use and maintain the equipment.
Support to develop new diagnostics fits within the DFID research strategy to address the need
for new or improved products to combat diseases of the poor, for which prevention or
treatment is lacking or inadequate. Development of new technologies will help to achieve the
Millennium Development Goals, notably to reduce poverty and child mortality, improve
maternal health and to combat malaria and other neglected diseases.
Section A: Detailed Output Scoring
Output 1: Development of new Point of Care (POC) diagnostics and improved quality of
existing POC tests for use at community level
Output 1 score and performance description: B – output moderately did not meet
expectation
Progress against expected results:
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TB: 2011/12 has been a time for consolidating previous successes in molecular testing and
advancing new diagnostics in to the portfolio. Key achievements include:
 A manual molecular diagnostic test for TB (TB LAMP) was registered in Japan and
phase 1 evaluation and demonstration projects were conducted in developing
countries;
 On-going work to improve the performance of drug (rifampin) resistance screening;
 Adoption of 2 new projects, including one which promises the ability to increase the
sensitivity and ease of sputum (phlegm) testing for TB in microscopy-level laboratories;
FIND and BD (Becton, Dickenson & Company) announced a new collaboration to
promote early and accurate diagnosis of multidrug-resistant TB (MDR-TB) among HIVinfected patients and other vulnerable populations in India, a country that accounts for
almost 25% of all TB cases globally.
Malaria: Key achievements include:
 First country-level introductions of a new, safer blood transfer device for point-of-care
malaria tests completed allowing for the simplification and improved safety of rapid
diagnostic test preparation by health workers.
 Near completion of field studies of rapid diagnostic test (RDT) screening for malaria in
pregnancy in Uganda and Burkina Faso
 Agreement of a new initiative between FIND and University College London (UCL) to
assess the feasibility of new approaches to testing for non-tolerance of certain (nonartemisinal) anti-malarial drugs (G6PD testing) allowing for safe treatment of malaria
Sleeping Sickness (human African trypanasomiasis): Key achievements include:
 Identification of biomarkers in the cerebrospinal fluid of sleeping sickness patients that
will allow for the distinction between stage 1 and stage 2 disease with a high degree of
accuracy – such distinction is critical given that patients with stage 2 disease can suffer
severe adverse effects, potentially even death;
 Signing of an agreement with Standard Diagnostics to develop a rapid diagnostic test
that tests for different stages of sleeping sickness and for cure.
Recommendations:
As the TB portfolio in particular starts to focus upon a range of higher risk projects care will
need to be taken to ensure all efforts are made to consolidate work in the areas of greatest
promise and halt work in failing projects at the earliest opportunity.
Impact Weighting (%): 40%
Revised since last Annual Review? Yes – to reflect balance of work in portfolio,
following an assessment of risks
Risk: Low/Medium/High Medium
Revised since last Annual Review? No
Output 2: Extension of existing technologies for use in the diagnosis of multiple rather
than single diseases, i.e. as diagnostic platforms rather than disease-specific tests.
Output 2 score and performance description: B – output moderately did not meet
expectation
Progress against expected results:
Strong progress has been made although not all milestones for the period have been met. Key
successes include:
 Entry of an assay (test) for measuring HIV viral load, and intended to help synergise TB
and HIV care, into late stage feasibility testing;
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Development of the first ever prototype rapid diagnostic test (RDT) for sleeping
sickness by FIND and their business partner, Standard Diagnostics (SD), in Korea –
early data from on-going trials in Angola and the Democratic Republic of Congo (DRC)
suggest this new rapid test performs as well as pre-existing tests which produce results
in slower time;
Completion of the first field applicable molecular diagnostic test for use in communitybased settings (HAT LAMP) by FIND and their partner, the Eiken Chemical Company;
Feasibility studies to develop manual (LAMP) diagnostic tests for both visceral
leishmaniasis and Chagas disease initiated
Manual malaria diagnostic test (malaria LAMP) completed field trials and is being
prepared for market release.
Recommendations:
FIND set themselves 17 milestones linked to outputs 1, 2 and 4for 2011; of these 11 were for
typical product development projects and 6 were for non-typical and implementation projects.
Overall, ten milestones were met, 6 were revised and one cancelled (that for the roll-out of the
Xpert MTB/RIF assay after it was decided that WHO would take the lead in guiding the
implementation of this technology post endorsement). The four main reasons for milestone
delays are: technical (difficulty in identifying thermostable targets in 1 project); clinical trial
delays (in 3 projects, delays due to slow ethical approval, slow enrolment because of declining
endemicity, and a change in principal investigator); and lastly, complications in partner
negotiations (for 2 projects). Some further progress has been made in the first half of 2012
and FIND has revised its milestone-setting practices in recognition that some have to date,
been over-ambitious, but further efforts are required to ensure these milestones are met in a
timely manner.
Given that parts of the portfolio associated with output 1 are likely to become higher risk in
coming years, FIND’s primary strategic challenge in the coming years will be to continue to
select areas of work where they can have the greatest impact and have lower levels of risk.
This will also be true for activities relating to output 3.
Impact Weighting (%): 15%
Revised since last Annual Review? No
Risk: Low/Medium/High High
Revised since last Annual Review? No
Output 3: Expansion of activities so that the programme portfolios include new disease
areas such as HIV and neglected diseases (where possible building upon the platforms
approach).
Output 3 score and performance description: A – output met expectation
Progress against expected results:
Progress has been relatively strong in this part of FIND’s portfolio, with developments seen
across HIV, visceral leishmaniasis and Chagas disease:
 The TB programme has been expanded to include other diseases where important
synergies exist, particularly across HIV and sexually transmitted diseases (STDs) The
sleeping sickness programme has been expanded to include leishmaniasis and
congenital Chagas disease, with feasibility tests for point-of-care (LAMP) diagnostics
for both diseases initiated;
 Plans to develop trachoma diagnostics are also under development
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Recommendations:
FIND need to be cautious about spreading resources too thinly across too large a range of
diseases. Emphasis should remain on the extension of existing diagnostic platforms to new
disease areas.
Impact Weighting (%): 25%
Revised since last Annual Review? Yes to reflect balance of work in the portfolio,
following an analysis of risks
Risk: Low/Medium/High Medium
Revised since last Annual Review? No
Output 4: Increased use of FIND diagnostics for disease testing amongst poor people in
endemic countries post WHO endorsement and introduction
Output 4 score and performance description: A+ – output moderately exceeded
expectation
Progress against expected results:
As various technologies have advanced through the product development pipeline and been
endorsed by the WHO, FIND has increased its efforts towards ensuring the availability and
use of their diagnostics on the ground in at-risk communities. Activities have included efforts to
promote new products, working with partners to reduce technology costs for low and middle
income countries, and laboratory strengthening and scale-up projects. Key activities
undertaken in the period 2011/12 include:
 By the end of 2011, liquid culture for TB and phenotypic drug susceptibility testing
(DST), the line probe assay for genotypic DST, and a rapid TB speciation test had been
introduced to 15 high-burden countries, and the Xpert MTB/RIF for case and multi-drug
resistant TB detection to two.
 Publication of 23 peer-reviewed academic papers since November 2011, with over 90
citations in other articles;
 Provision of technical support to WHO in the development of policy guidance for the
use of the rapid, automated TB test (Xpert MTB/RIF), previously developed by FIND
and partners, and endorsed by the WHO in 2011;
 Deep engagement in early implementation efforts associated with the role out of the
automated TB Xpert test, including laboratory capacity-strengthening activities, and
 Successfully advocating for lower pricing for low and middle income countries (as
indicated by an August 2012 announcement that a number of donors are to subsidise
the cost allowing for a price reduction from $16.86 per diagnostic cartridge to $9.98 in
145 high-burden countries);
 On-going quality control for rapid diagnostic tests in partnership with WHO and
expansion to include other types of (recombinant antigen) tests;
 Conduct of a pilot test of the use of SMS (text message) reporting for malaria diagnosis
which has led to the national scale up of the approach by the Ministry of Health in
Uganda
 FIND worked with partners including the National Malaria Control Programmes in
Senegal and Zambia to assess the impact of wide-scale rapid diagnostic tests (RDTs)
on disease reporting and drug consumption with a view to build the evidence base to
guide the expansion of RDT use;
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On-going work towards enhancing the capacity for diagnostic testing for TB, malaria
and HIV through laboratory strengthening in Vietnam, Botswana, Dominican Republic,
South Africa, Tanzania and Lesotho
Recommendations:
FIND’s efforts in this area have been impressive during the year. However they may need to
balance efforts in this area with the need to maintain an active and progressive diagnostics
development pipeline for the future.
At the end of 2011 the ‘downstream programme team’ responsible for the delivery of this
output began a process of restructuring. FIND must manage this change carefully, to ensure
success, to ensure such strong performance in this area is to be maintained.
Impact Weighting (%): 20%
Revised since last Annual Review? No
Risk: Low/Medium/High Medium
Revised since last Annual Review? No
Section B: Results and Value for Money.
1. Progress and results
1.1 Has the logframe been updated since last review? No
1.2 Overall Output Score and Description: A – Output met expectation
1.3 Direct feedback from beneficiaries
FIND has worked to ensure that the diagnostics it develops are appropriate for use in
developing countries and can reach those most in need. FIND takes a people-centred
approach with a focus on ‘introducing new and improved diagnostic tests to shorten the delay
before treatment, to halt transmission, and to minimise the impact of disease on families and
communities’ (p.3, The Diagnosis Path to a Better World – available on the FIND website:
www.finddiagnostics.org). FIND works closely with governments, regional and district health
authorities to facilitate the introduction of new tools into existing systems, supporting the
upgrade of laboratories, strengthening technical capacity and ultimately roll-out of new
diagnostic tools enabling poor people in communities to access the diagnostics and the right
treatments required.
1.4 Summary of overall progress
FIND has performed well in the period 2011-12, with slight under-achievements in some areas
of their work being offset by over-achievement in others. In the past year while fewer new
diagnostics have been endorsed by the WHO and entered the global market than previous
years, FIND has continued to demonstrate the development of diagnostics across all stages of
the product development pipeline and all three disease areas (TB, malaria, and sleeping
sickness). However, they recognise they have not met all their point of care milestones for the
year and need to focus upon taking forwards their antigen detection rapid diagnostic testing
work particularly for TB. Their work on expanding the diseases covered and developing
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diseases clusters and increasing use of diagnostics has been strong.
1.5 Key challenges
Through the successful development and WHO prequalification of a number of new diagnostic
tests FIND has significant challenges to ensure that the new diagnostics will have the desired
impact in disease endemic countries. It is clear that FIND is reorganising to ensure sufficient
capacity to introduce new diagnostics and associated appropriate uptake.
Changes in the senior management and associated organisational restructuring that occurred
in 2011-12 are likely to pose some challenges in the period 2012-13. However, FIND is
working to ensure these changes are managed as smoothly as possible.
FIND needs to ensure that it works with partners who are able to conduct ongoing surveillance
of new products once they are being used in the field.
Volatile exchange rates and the prolonged effects of the global economic downturn have had
an impact on financial operations throughout the year. In common with other Swiss-based
organisations the escalation in the value of the Swiss Franc against US $ has greatly
increased the Geneva-based costs (e.g. WHO has reported increases of some 40% in
operating costs). Many of FIND’s staff are based outside of Switzerland and rigorous financial
management is mitigating some of the effect of the currency fluctuations.
Finding, reaching and staffing appropriate trial sites in endemic areas, particularly for lower
burden diseases such as sleeping sickness, continues to pose challenges. However, FIND’s
continuing emphasis on laboratory-strengthening activities in-country helps to reduce these
challenges over time.
1.6 Annual Outcome Assessment A – Outcome met expectation
FIND has made good progress against its outcome i.e. to drive the development and
implementation of accurate and affordable diagnostic tests that are appropriate to patient care
in low-resource settings. We anticipate with the changes in management that FIND will
continue to perform well during the remainder of the funding period. During the past year
FIND has been successful, through a highly competitive process to attract significant funding
from the German Government, in its first open competition for product development
partnership funding.
2. Costs and timescale
2.1 Is the project on-track against financial forecasts: Yes
2.2 Key cost drivers
Diagnostics development is a costly process, especially in the latter stages of development
and/or when working on lower burden diseases (which may be targeted for elimination). As
new products progress through the pipeline they enter into successively more costly phases of
development. The programme is aware and actively trying to manage resources to ensure
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that there are funds available to test the most promising products as they are developed. This
includes widening partnership with the private sector in low, middle and high income countries
and leveraging of resources, in-kind contributions and expertise; working with other not-forprofit organisations to share costs wherever possible. Further, diagnostics development
remains cheaper than research and development activities in other areas such as vaccines
and drug development. FIND’s emphasis on the use of transferable diagnostic platforms
further lowers costs and risks.
FIND has expanded its portfolio of diseases covered and increased its efforts to ensure
diagnostics reach the people most in need. There is a need to ensure a balance across the
whole programme of work, within financial constraints, to ensure an active and progressive
diagnostics development pipeline for the future
During 2012 obtained a significant new funding commitment (EUR7.5million) from the German
Federal Ministry of Education and Research, which will run to November 2015, with preexisting donors continuing to support FIND. A two-year, US$11 million, TB grant from the Bill
and Melinda Gates Foundation was also granted during 2012.
2.3 Is the project on-track against original timescale: Yes
3. Evidence and Evaluation
3.1 Assess any changes in evidence and implications for the project
No significant changes to report. Diagnostics remain an underserved area and FIND
continues to be one of the few groups working in the area, with a recognised track record
focused solely on diagnostics. In spite of the global financial situation, FIND continues to
successfully mobilise funds in an ever more competitive funding environment slight reductions
in funding have occurred, but these have only acted to push them towards minimising their
operating costs and maximising the efficiency of resource utilisation further.
All diseases within their portfolio continue to represent key areas of diagnostic need.
3.2 Where an evaluation is planned what progress has been made?
Not applicable
4. Risk
4.1 Output Risk Rating: Medium/High
4.2 Assessment of the risk level
Following internal DFID discussions about the risk to the programme it moves from medium to
medium/high risk.
Product development is high risk and potential new diagnostics can fail at any stage in the
development process. Risks are however lower than in other areas of innovation such as
vaccine development. The product development partnership model represents a mechanism
to mitigate the risks associated with the development of diagnostics (as well as vaccines and
drugs) for diseases where there is little likelihood of private-sector diagnostic companies
recovering the costs of development. FIND’s strategy to manage a portfolio of diagnostic
platforms (rather than single candidates) that can be used across a range of diseases,
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reduces the overall risk. FIND and their partners have robust mechanisms to manage their
portfolios of potential diagnostic products , drawing on global experts to oversee the
development process and help teams to identify milestones and stop/go decision points. .
As the number of products reaching commercialisation in recent years increases, there is a
concurrent portfolio shift towards a larger number of early stage projects which naturally
represent higher risk. FIND has strong mechanisms in place to minimise these risks with
strong go/no go decision points built in to the product development process.
FIND experienced significant management and organisational changes in late 2011, with a
new Chief Executive Officer being appointed in 2011 and a subsequent reduction in the
number of staff employed by the programme; the long-time Chief Financial Officer (CFO) also
retired at the end of the year and a new CFO has taken on the interim-role. FIND is in the
process of developing a new 5-year strategy and revising its organisational structure and
systems to improve efficiency and reduce operational costs. They have established a
permanent Scientific Advisory Committee which will complement the ad-hoc committees to
provide external scrutiny for managing individual projects within the portfolio and strengthen
both other committees and the Board.
While these changes appear to be being managed smoothly, such extensive organisational
changes do not come without their risks. These points are reflected in the re-assignment of
this programme from ‘medium’ to ‘medium/high’ risk.
4.3 Risk of funds not being used as intended
This is low risk. An external independent Financial Audit is performed annually to certify the
availability of funds and assess adequacy of funds. Copies of the unqualified Audited
Financial Statements for 2011 have been examined by DFID.
During the year FIND changed its revenue recognition policy to better reflect the funds
available to the organisation at the end of each year. This change in accounting priority, first
applied for the period 2011 with retroactive effect on prior years, revealed an accumulated
deficit. However the auditors (Deloitte) highlighted that there was sufficient cash to cover
FIND’s 2012 operations.
FIND’s management and Board of Directors have since taken active measures to resolve the
situation. As of August 2012, FIND has secured unrestricted funds from various donors to
cover the accumulated deficit.
The provision of core funds to manage its portfolio of potential diagnostics is a way to manage
the risk that any one project is unsuccessful and that work will stop. The organisation is able to
reassign funds to more promising projects and ensure that work continues.
FIND has a strong a governance structure and robust practices. In response to previous
external reviews, including a 2011 one co-funded by the Bill and Melinda Gates Foundation
and the Dutch Government, these have been recently strengthened further (see FIND’s 2011
Annual Funders report for further detail). While this review document has not yet been made
public, its conclusions and recommendations have been discussed at length during meetings
of the PDP Funders Group and DFID have discussed them with FIND staff members.
4.4 Climate and Environment Risk
There are no significant environmental impacts of FIND’s work programme at this time. FIND
works with regulators to ensure that environmental issues (associated, for example, with used
product and packaging disposal) are appropriately addressed and/or studied as part of the
development process, prior to the adoption of tests. The WHO prequalification process for
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any new diagnostic involves an assessment of potential climate and environment risks.
In the longer terms the environmental impacts of FIND’s activities should be positive with
reduced inappropriate treatments of disease in poor populations contributing to more effective
and efficient utilisation of drugs and associated health services.
5. Value for Money
5.1 Performance on VfM measures
Funding diagnostics development through a product development partnership (PDP) such as
the Foundation for Innovative Diagnostics (FIND) provides value for money through:
 the use of a portfolio approach which allows funding to be redistributed if individual
projects are stopped if they do not meet their milestones;
 the leveraging of contributions (resources, expertise, funding, access to drugs and
other in-kind resources) from the private sector (in low, middle and high income
countries);
 support for the continued development of the most promising candidates; facilitating
opportunities to explore innovative partnerships with private and public sector
organisations (in many different countries including low and middle income countries) to
reduce costs.
FIND further enhances its value for money through strong partnership working with other
PDPs (e.g. the TB Alliance) as well as policy-makers, influencers, operational researchers and
programme staff on the ground – such involvement significantly increases the likelihood and
timeliness of diagnostic uptake in endemic countries.
5.2 Commercial Improvement and Value for Money
Through its internal processes, with a focus on the development of new disease diagnostics
from existing technology platforms, the programme is able to provide a competitive
environment for innovation and improved value for money. In addition the organisation works
with the diagnostics industry which improves value for money, by leveraging in resources, staff
time and expertise from other organisations
5.3 Role of project partners
DFID is one of a number of donors all of whom are involved through regular discussions with
the programme directly and through various international and WHO based fora. All donors are
aware of the financial constraints and the need to identify ways to increase value for money.
Ensuring value for money in developing products for use in low income countries, where there
is no viable commercial market, is central to the way PDPs work with their partners from a
range of different backgrounds, including pharmaceutical companies, other private sector
organisations, academic researchers, advocacy organisations and local community groups.
5.4 Does the project still represent Value for Money : Yes
5.5 If not, what action will you take?
6. Conditionality
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6.1 Update on specific conditions
Not applicable
7. Conclusions and actions
Overall FIND has made good progress over the 2011/12 period with slight underachievements under outputs 1 and 2 being offset by strong performance under outputs 3 and
4, supporting the roll-out of diagnostic products among populations at need.
There have been some changes in management structures over the cause of the year, the
impacts of which appear to have been managed smoothly, and will be monitored closely
during the coming year.
8. Review Process
The review was carried out by members of the human development research team in DFID,
following review meetings and discussions with the programme, independent scientific experts
and other funders. A member of the Product Development Partnership Funders Group was an
independent member of the review team.
Further supporting materials included reports from the FIND website, annual reports and
regular FIND email updates
As the new Product Development Partnership Competition (for the period 2013-18) was
launched in February 2012, there has been minimal contact with FIND to minimise the risk of
conflict of interest. All discussions with the programme have been limited to reviewing progress
against the existing performance framework, risk, financial and programme management.
However, a copy of this annual review was shared with them before submission. When the
competition is complete, by end of 2012, further discussions will take place. Given
management and organisational changes in 2011-12 we will monitor progress closely over the
coming year.
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