A group of global health nonprofits and initiatives led by the World Health Organization (WHO) has finalized its first contracts that aim to deliver inexpensive and rapid antigen diagnostic tests for COVID-19 to low- and middle-income countries.
The agreement with Premier Medical Corporation, based in India, includes R&D, technology transfer and scale-up provisions, with the goal of automating the company’s manufacturing capacity to deliver at least 250 million test kits for less than $2.50 apiece.
That price point would be less than half of the currently available rapid antigen tests prequalified by the WHO, manufactured by Abbott and SD Biosensor at $5 per test.
The project is supported by the Foundation for Innovative New Diagnostics—or FIND, an international nonprofit that collaborates with the WHO to build up laboratories and evaluate medical tests—and Unitaid, which provides short-term grants and investments to companies focused on HIV, AIDS, tuberculosis and malaria.
Together, they plan to boost production, currently at 3 million tests per month, to up to 10 million per month by the third quarter of this year.
The upgraded manufacturing capacity may also be used in the future to make tests for other infectious diseases or potential pandemics. Premier’s tests must still be assessed and listed by the WHO for emergency use in order to meet the contract’s terms.
“Testing has been our compass in the fight against the pandemic and will continue to play a key role in gauging the effectiveness of vaccinations in communities,” the WHO’s director-general, Tedros Adhanom Ghebreyesus, said in a statement. “Today’s announcement brings new hope for the many countries that have flown blind in the face of the pandemic because they could not access or afford diagnostic tools.”
The deal was formed under the diagnostics pillar of the WHO’s Access to COVID-19 Tools Accelerator, or ACT, which estimates that 500 million COVID-19 tests are needed in low- and middle-income countries by the end of 2021. The ACT-Accelerator estimates at least 75% of those tests should be deployed in decentralized, point-of-care settings—such as primary care and community clinics, and for triage in hospitals—where antigen tests have an advantage over resource-reliant molecular lab tests.
“I urge the global community to keep supporting the ACT-Accelerator and bridge the funding gap of more than US$5.3 billion still needed for diagnostics,” Tedros said.
The accelerator as a whole—which also spans vaccines, therapeutics and health systems—currently has funding commitments totaling $6 billion, with an additional $4 billion projected, but it still faces a budget gap of $27.2 billion for its global efforts.
The WHO also published the latest edition of its annual list of essential diagnostics, expanding it to include PCR- and antigen-based coronavirus tests. Similar to its list of essential medicines, the guide is intended as a policy tool for countries building their own medical inventories.
For COVID-19, testing has been concentrated in high-income countries, with an estimated rate of 252 tests per 100,000 people per day compared to 10 times lower in low- and middle-income countries.
“With the availability of more affordable quality rapid tests, countries must now scale up COVID-19 testing in the communities using rapid tests as well as centralised molecular testing wherever possible,” said Stijn Deborggraeve, a diagnostics adviser for Doctors Without Borders’ Access Campaign.
“Premier Medical Corporation applied for WHO emergency use listing of their COVID-19 antigen rapid test and, if it meets the quality and performance standards for listing, the initiative will challenge the market of WHO-prequalified COVID-19 antigen rapid tests, increasing competition and ensuring affordable prices for lower- and middle-income countries,” Deborggraeve said.
“With the planned production of 120 million COVID-19 tests per year, we hope that Premier Medical Corporation will also remain committed to maintaining supply levels of its other critical tests, such as those for malaria, HIV and hepatitis.”