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FIND $7M Funding for SARS-CoV-2 Self-Tests Aims to Enable More Equitable Distribution to LMICs

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NEW YORK — Geneva-based FIND is seeking to narrow the gap between rich and poor countries around access to SARS-CoV-2 self-testing.

The global nonprofit recently announced that it has awarded $7 million to four Asian companies for the development and supply of antigen self-tests for SARS-CoV-2 in low- and middle-income countries, saying the award is part of a larger strategy to enable more equitable distribution of the tests globally.

The funding is expected to boost the supply of affordable self-tests, making them available to individual LMICs for procurement, FIND Chief Technology Officer Marta Fernández Suárez said in an interview.

As self-testing became available in high-income countries last year, many questioned whether the tests could be successfully adopted in LMICs, she said, adding that FIND has "shifted the conversation" to the utility and benefits of self-tests.

"We started working on self-testing at first because we believe in patient empowerment and better access at a time that health systems have been overburdened with testing demands," Fernández Suárez said. "Some testing can be done in healthcare settings but there is a lot that individuals can do in their homes."

Further, in LMICs where the infrastructure for RT-PCR testing does not exist, antigen testing for SARS-CoV-2 is the only option.

Following a request for proposals, the Swiss nonprofit last month announced that it has awarded funding to China's Acon Biotech and Jiangsu BioPerfectus Technologies, South Korea-based Osang Healthcare, and India-based Premier Medical.

FIND said that the companies have committed to manufacturing up to 60 million COVID-19 self-tests per month in aggregate, and offering them in LMICs at $1 to $2 each.

"The most important part of the new awards announcement is not so much that these are self-tests … but the price," said Joe Fitchett, senior adviser for biotechnology at the Institut Pasteur de Dakar, which is planning the release of an antigen self-test for home and over-the-counter use in Senegal.

"Two years on from the start of the pandemic we have finally reached a publicly announced $1 price at point of manufacture," said Fitchett, who is not affiliated with the FIND initiative, adding, "This is welcome news, and allows for more innovation and effort to distribute these kits to those that need them most at low cost."

Tunc Mert Sayin, a deputy general manager of Jiangsu BioPerfectus Technologies, said in an email that the recent award will enable it to supply self-test kits that are more affordable and easier to use than current kits in the market.

FIND's funding announcement preceded the World Health Organization's release of guidance last week recommending the use of antigen tests for COVID-19 self-testing, a development that aligns well with FIND's initiatives, Fernández Suárez said.

The new guidance recommended timely and accurate self-testing as an essential part of a comprehensive COVID-19 response strategy, and according to WHO, is relevant to policymakers, program managers, health workers, and pharmacists responsible for planning and implementing SARS-CoV-2 testing, prevention, care, and treatment services in LMICs.

Fernández Suárez added that the WHO guidance is an essential element to removing a barrier to adoption and accelerate the development of self-testing policies and guidelines in individual low- and middle-income countries.

With policies and guidelines in place, regulatory agencies in LMICs seeking to adopt self-testing can then accept submissions for test registrations from self-test companies.

Obtaining such registrations has been a big bottleneck for companies and something that FIND with other partners "have been trying to harmonize," Fernández Suárez said.

More reliance on previous authorizations of tests by national regulators such as the US Food and Drug Administration, Australia's Therapeutic Goods Administration, and others would streamline registrations.

In such a scenario, each test supplier wouldn't have to validate and register its test in each country, she said, adding, that in LMICs, "it's still a very fragmented process and one that is really hampering access to the tests."

The lack of SARS-CoV-2 tests, including self-tests, has been a worldwide concern throughout the pandemic, but far fewer SARS-CoV-2 tests have been available in low- and middle-income countries than in high-income countries.

As of this week, 10.59 per 1,000 people in high-income countries were getting SARS-CoV-2 tests compared to 0.78 per 1,000 in upper middle-income countries; 0.92 per 1,000 in lower middle-income countries; and 0.10 per 1,000 in low-income countries, FIND said.

Currently, only a few LMICs, including Brazil, the Philippines, India, Malaysia, and Thailand, have started to adopt SARS-CoV-2 self-testing, but with the recent awards by FIND and the WHO guidance, "the majority are expected to adopt [such testing] by the end of this year," said Elena Ivanova Reipold, FIND's technology innovation lead for self-testing.

The firms that FIND selected have already developed self-tests and are seeking registration and validation in LMICs that have decided to allow self-testing, she said, adding that FIND will provide technical assistance and perform in-country independent clinical evaluations of the tests prior to their deployment.

According to Reipold, FIND's initiative to support SARS-CoV-2 self-testing was motivated in part by the success of such testing for HIV in LMICs following the introduction of HIV self-testing guidance by the WHO in 2015.

Additionally, "we have done a lot of groundwork on hepatitis C self-testing" in LMICs, providing evidence that became the basis of WHO guidelines on the topic, said Reipold, who led the FIND hepatitis C self-testing initiative prior to leading such testing for SARS-CoV-2.

"Within the hep C program, we uncovered convincing evidence showing that people throughout the general population are confident in performing self-testing," Reipold said.

Subsequent to the announcement of the $7 million award last month, FIND on Thursday announced another deal aimed at enabling more equitable access to SARS-CoV-2 testing, saying that it has formed two partnerships to implement rapid antigen testing for COVID-19 among vulnerable, displaced people in the Middle East region, for whom access to such testing has been a major challenge.

Last December, FIND also awarded $21 million to four companies for the development and supply of low-cost, multiplex molecular tests to provide a differential diagnosis for SARS-CoV-2, influenza, and respiratory syncytial virus.

The initiatives support the objectives of the Access to COVID-19 Tools Accelerator (ACT-A), a global healthcare collaboration whose diagnostics pillar is co-led by FIND and the Global Fund, Fernández Suárez noted.

ACT-A has established a global target for the use and availability of one SARS-CoV-2 test per 1,000 people per day, including PCR and rapid antigen assays that are either self-tests or implemented by professionals.

According to FIND, the perception of rapid antigen tests as low quality has been an ongoing obstacle to adoption.

FIND said it selected companies for awards that are already manufacturing tests with high quality and a level of performance equivalent to the highest performing SARS-CoV-2 antigen testing in the market.

FIND and its health partners are also gathering evidence to support guidance that informs how self-tests can be used "most efficiently including when serial testing makes sense and when one-off testing makes sense," Reipold said, adding that following the release of guidance recommending self-testing, "the next big step would be to understand how to use this test in the smartest way possible."