Tech transfer deals to lower costs of COVID-19 rapid tests

Two manufacturers will soon be able to produce COVID-19 rapid diagnostic tests that are expected to be more affordable and more accessible to countries in Africa and Latin America.

Unitaid and FIND announced three technology transfer agreements last week that would boost regional production of COVID-19 rapid tests. U.S.-based firm DCN Dx has agreed to share its know-how with WAMA Diagnóstica in Brazil. South Korean company Bionote and U.K. firm Mologic — a social enterprise — have both agreed to share their knowledge with Diatropix, a nonprofit manufacturing facility under the Institut Pasteur de Dakar in Senegal.

Unitaid and FIND are funding the technology transfers from the developers, as well as the scale up of test production at the manufacturing sites, Vincent Bretin, director of the Results Division at Unitaid, told Devex in an emailed response. The costs include building human resource capacity, the space and expansion of the manufacturing facility, and supplies, he said.

“These investments also benefit from a larger ACT-A [Access to COVID-19 Tools Accelerator] partnership structure, including the technical and market access expertise of Unitaid and FIND, the support of major procurers, and Unitaid’s catalytic introduction projects with CHAI [Clinton Health Access Initiative] to increase demand,” he added.

The deals are part of current efforts to diversify manufacturing for COVID-19 health products and build local and regional manufacturing capacities benefitting low- and middle-income countries.

In the case of COVID-19 rapid tests, most of the supply in low- and middle-income countries are coming from just two countries — India and South Korea — and both are located in Asia. This meant a lack of market competition to drive down pricing. Early on in the pandemic, import and export restrictions such as from China also limited many countries’ access to tests.

The agreements are expected to lower the costs of COVID-19 rapid tests to as little as $2. In 2020, COVID-19 tests made available to the public health sector in countries in Africa and Latin America were priced at $5 via pooled procurement. With the entry of new tests in the market, pricing for tests eventually came down to $2.5 to $4. However, outside of pooled procurement, market prices of tests can go as high as $7, according to Dr. Marta Fernández Suárez, senior director of R&D at FIND.

“We know that some tests are available at lower prices, though data [on] performance and actual sales are lacking,” she told Devex via email.

The ceiling prices per test were a critical part of the tech transfer negotiations, and are expected to result in significant savings in the procurement of these tests, but also lead to lower prices for other similar tests in the market, Fernández Suárez said.

Through the deals, WAMA Diagnóstica is expected to produce as many as 2 million tests per month. Diatropix meanwhile will be seeking regulatory authorization to commercialize the tests with its own brand and produce up to 2.5 million tests per month by 2022.

“Both companies will be able to produce tests starting this year, although their ability to market them under the agreements will ultimately depend on the timelines for regulatory authorization,” Fernández Suárez said.

While price and access are important considerations for the agreements, partners also hope the deals would have longer-term implications such as access to locally manufactured tests for other diseases in Africa and Latin America, and lead to more tech transfer deals. According to Fernández Suárez, other organizations are working on similar tech transfer arrangements on COVID-19 diagnostics “that may be executed in the coming months.”

“We are working closely with the tech transfer partners to develop appropriate business models to ensure sustainability, as well as identification of additional funding sources, if needed,” she added.

The deals are expected to lead to increased testing in countries, although Unitaid’s Bretin said there are other factors at play limiting COVID-19 testing in countries, such as lack of experience in the use of antigen tests and access to funding to purchase the tests.

“We are working on other projects to address these gaps in countries, and ACT-A partners are also mobilized to ensure scale up of testing,” he said.

Update, July 26: This story has been updated to clarify Mologic is a social enterprise.