FIND and Unitaid launch call for expressions of interest to accelerate availability and manufacturing scale-up of rapid diagnostic tests for COVID-19

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• Call aims to fill major diagnostic gaps in the detection of active SARS-CoV-2 infection for patient management and contact tracing purposes in decentralized settings, most critically needed in low- and middle-income countries (LMICs)
• Innovators, developers and manufacturers of rapid diagnostic tests and in vitro diagnostics, and LMIC-based diagnostic stakeholders, are invited to submit proposals
• Launch of this EOI is the latest milestone for the Access to COVID-19 Tools (ACT) Accelerator Diagnostics Pillar, co-convened by FIND and The Global Fund to Fight AIDS, Tuberculosis and Malaria

Geneva, Switzerland – 9 July 2020 – The Foundation for Innovative New Diagnostics (FIND) and Unitaid announced today that the organizations have launched a call for expressions of interest (EOI) to accelerate the availability and manufacturing scale-up of rapid diagnostic tests for the detection of SARS-CoV-2 antigens (Ag RDTs). Reliable, affordable Ag RDTs have been identified as key tools in the global response to COVID-19, as they could enable robust detection of active SARS-CoV-2 infection for both patient management and contact tracing purposes in decentralized settings. This EOI is has been prepared in the context of the Access to COVID-19 Tools (ACT) Accelerator Diagnostics Pillar, co-convened by FIND and The Global Fund to Fight AIDS, Tuberculosis and Malaria.

High-quality, accurate testing data offers reliable information that can save lives and enable economies to re-open safely: by isolating those who are infected, we can break the chain of transmission. While vaccine research is moving fast, promising treatments are also beginning to emerge and testing will be essential to determine who should be treated with which therapy. With today’s laboratory-based molecular tests, testing capacity is currently highly centralized, and often insufficient to meet the current demand. While countries in all regions have experienced testing challenges, the needs are more acute in low- and middle-income countries (LMICs), where fragile health systems and exclusive reliance on global supply chains have often left LMICs unable to access much-needed tests. Decentralizing testing – so it can be made available in primary care, in community settings, and potentially even at home – will be critical to support the introduction of treatments, and later the roll out of vaccines.

As set out in the ACT-Accelerator Diagnostics Pillar investment case, an estimated 500 million COVID-19 diagnostic tests will be needed in LMICs over the next 12 months, 75% of which in decentralized settings (i.e. primary healthcare, community-level care, hospital triage). There is emerging consensus about the important role that SARS-CoV-2 Ag RDTs will play, as the primary diagnostic for active infection detection in decentralized settings where timely molecular testing is not available.

The EOI has been launched to support the work plans of two working groups within the ACT-Accelerator Diagnostics Pillar: “R&D of tests & digital tools” (led by the Bill & Melinda Gates Foundation and the Praesens Foundation) and “Market readiness” (led by Unitaid and FIND). Proposals are invited from innovators, RDT developers, in vitro diagnostics (IVD) manufacturers and LMIC-based diagnostic stakeholders, in two key areas:

• Accelerating development and market entry of improved, quality-assured SARS-CoV-2 Ag RDTs for expanded use in LMICs
• Rapidly creating the supply conditions (manufacturing capacity, diversity of supplier base, affordability) to meet the needs of LMICs

An initial budget envelope of up to US$40 million of grant funding, to be made available by FIND and Unitaid and supplemented by loan funding from development banks, could support at least 2–4 proposals that offer best value for money. As additional funding becomes available, further proposals will be considered. Funding negotiations will be conducted independently for each proposal, and will be tailored to the applicant’s needs and the specifics of each business case. Funding could take many forms, such as R&D grant funding, loans for infrastructure scale up, licensure agreements, and/or longer-term volume commitments.

This EOI is the latest milestone in progress made by the ACT-Accelerator Diagnostics Pillar, which in the last 8 weeks has included the set-up of a multi-country evaluation platform to “test the tests” (results now published for evaluations of both molecular tests and immunoassays), completion of a modelling analysis to quantify the impact of COVID-19 testing to inform country policy and strategy, and procurement of over 5 million diagnostic tests through the World Health Organization (WHO) Supply Consortium.

Catharina Boehme, CEO of FIND, said: “Testing is already enabling countries to implement test-trace-isolate strategies, which have had a dramatic effect on containing the pandemic in countries including New Zealand, South Korea and Germany. But low- and middle-income countries are being left behind. Simple, affordable, high-quality antigen RDTs will enable COVID-19 diagnosis without the need for complex laboratory facilities – which will be vital to treating quickly and appropriately.”

Philippe Duneton, Unitaid Executive Director a.i., said: “We need 500 million COVID-19 tests for low and middle-income countries in the next 12 months. To reach that target we need cheaper and easier to use tests such as antigen RDTs. Accelerating their development and manufacturing scale-up is key to enable access to testing worldwide.”

Peter Sands, Executive Director of The Global Fund, said: ““Mobilizing new partners is a critical step toward scaling up test, trace and isolate strategies to stop the spread of COVID-19 and to roll out treatments and vaccines once available. We urgently need fast, easy-to-use tests that can be used not by professional medical staff like doctors and nurses, but also by the community health workers who are on the frontlines of fighting COVID-19 in the most vulnerable communities around the world.”

Full details on the EOI and information on how to apply can be found here: www.finddx.org/eoi-covid19-ag-rdt/. Two workshops for potential applicants will be held on Friday 10 July 2020 at 07:00 CET and 17:00 CET. Participation is by registration only; for details please write to RSVP-unitaid@who.int.

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About the Access to COVID-19 Tools (ACT) Accelerator
The Access to COVID-19 Tools ACT-Accelerator, is a new, ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. It was set up in response to a call from G20 leaders in March and launched by the WHO, European Commission, France and The Bill & Melinda Gates Foundation in April 2020. The ACT-Accelerator is not a decision-making body or a new organization, but works to speed up collaborative efforts among existing organizations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines, thereby protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organizations which are tackling the world’s toughest health challenges, and who, by working together, are able to unlock new and more ambitious results against COVID-19. Its members share a commitment to ensure all people have access to all the tools needed to defeat COVID-19 and to work with unprecedented levels of partnership to achieve it. The ACT-Accelerator has four areas of work: diagnostics, therapeutics, vaccines and the health system connector. Cross-cutting all of these is the workstream on Access & Allocation

About FIND
FIND is a global non-profit organization that drives innovation in the development and delivery of diagnostics to combat major diseases affecting the world’s poorest populations. Our work bridges R&D to access, overcoming scientific barriers to technology development; generating evidence for regulators and policy-makers; addressing market failures; and enabling accelerated uptake and access to diagnostics in low- and middle-income countries (LMICs). Since 2003, we have been instrumental in the development of 24 new diagnostic tools used in 150 LMICs. Over 50 million FIND-supported products have been provided to our target markets since the start of 2015. A WHO Collaborating Centre, we work with more than 200 academic, industry, governmental, and civil society partners worldwide, on over 70 active projects that cross six priority disease areas. FIND is committed to a future in which diagnostics underpin treatment decisions and provide the foundation for disease surveillance, control and prevention.

About Unitaid
Unitaid is a global development agency engaged in finding innovative solutions in global health, including new ways to prevent, diagnose and treat diseases more quickly, cheaply and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV/AIDS, malaria and tuberculosis, as well as HIV co-infections and co-morbidities such as cervical cancer and hepatitis C, and cross-cutting areas, such as fever management. Unitaid is hosted by the World Health Organization.

Media contacts
FIND: Sarah-Jane Loveday, Head of Communications
M: +41 79 431 62 44
media@finddx.org

Unitaid: Martin Harvey, Team Lead, Communications
M: +41 79 249 35 29
harveym@unitaid.who.int