Local manufacturing of COVID-19 rapid tests in Africa and Latin America will be dramatically expanded, thanks to investment from FIND, the global alliance for diagnostics, and Unitaid.
Following a call for Expressions of Interest launched under the Access to COVID-19 Tools (ACT)-Accelerator Diagnostics Pillar, contracts have now been finalized to drive equitable access to fit-for-purpose antigen rapid diagnostic tests (Ag RDTs) for COVID-19.
The pandemic has exposed how fragile health systems and exclusive reliance on global supply chains leave many countries without access to the tests they need to control COVID-19. The high-income countries are testing people for COVID-19 over 60 times more than low-income countries. Expanded production capacity in local and regional hubs is critical to ensuring that healthcare providers in low- and middle-income countries (LMICs) can implement effective testing strategies to contain the spread of the virus.
Agreements have been signed to support collaborations between Xixia Pharmaceuticals (a subsidiary of Viatris) and Guangzhou Wondfo Biotech (Wondfo), DCN Dx, and WAMA Diagnóstica, and DIATROPIX of the Institut Pasteur de Dakar, Bionote, and Mologic.
FIND and Unitaid is supporting the creation of a Centre of Excellence at DCN Dx to facilitate RDT technology transfer to LMIC manufacturers. WAMA Diagnóstica, based in Brazil, is the first of these and will supply the Latin America and Caribbean region. Test volumes are expected to reach 2 million tests per month, with a ceiling price of US$2.00.
To serve the African continent, DIATROPIX of the Institut Pasteur de Dakar in Senegal is being supported to scale up manufacturing of Ag RDTs transferred from Mologic and Bionote. Through this support, diatopic will seek regulatory authorization for the transferred tests and commercialize them under its own brand, with the aim of reaching 2.5 million tests per month by 2022, at prices ranging from US$2.50 to US$2.00 with a view to further reductions in the near future.
In a further boost to testing capacity in LMICs, FIND and Unitaid announce that Wondfo, based in Guangzhou, China, is teaming up with Viatris (operating through its subsidiary Xixia Pharmaceuticals based in Gauteng, South Africa) to bring its low-cost Ag RDTs to market in LMICs. This partnership between a high-volume manufacturer and a distributor with global reach has the potential to produce 144 million tests per year, at a ceiling price of US$2.50.
Recently released WHO guidance on national SARS-CoV-2 testing strategies emphasizes the important role of high-quality Ag RDTs. They remain the primary diagnostic test for the detection of active SARS-CoV-2 infection in decentralized settings where timely molecular testing is not available.
Marta Fernández Suárez, Senior Director of R&D at FIND, said: “Scaling up testing capacity in LMICs is one of our highest priorities. The expression of interest (EOI) process has enabled us to identify partnerships that we believe can have a great impact in key regions that are of critical importance to the pandemic and potentially beyond, to help ensure that everyone who needs a test can get one.”
Vincent Bretin, Director of Results at Unitaid, said: “Increasing the capacity of local and regional hubs to produce COVID-19 tests will be vital if we are to ensure truly equitable access to this crucial tool. Currently, the vast majority of rapid tests being used in low- and middle-income countries are manufactured in just two countries in one region, so these agreements are an important step in ensuring that countries are equipped to detect cases of COVID-19, helping contain outbreaks and bringing a swifter end to the pandemic.”
