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.
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.”
Catharina Boehme, CEO of FIND
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.”
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.”
Peter Sands, Executive Director of The Global Fund