The Foundation for Innovative New Diagnostics (FIND) and Unitaid on Friday announced that they have finalized the first among a set of agreements that will enable more than 250 million rapid antigen tests (Ag RDTs) per year to be made available for low- and middle-income countries (LMICs) for a unit price of less than $2.50 apiece.
The announcement on behalf of a World Health Organization program, Access to COVID-19 Tools (ACT) Accelerator Diagnostics Pillar, followed an open call for Expressions of Interest (EOI) launched in July 2020. FIND and Unitaid launched the EOI on behalf of the Market Readiness Working Group of the ACT-Accelerator Diagnostics Pillar.
The first agreement announced on Friday is with Premier Medical, headquartered in Sarigam Gujarat, India.
With support from FIND and Unitaid, the company will facilitate market entry of a new Ag RDT that meets WHO quality criteria. The agreement calls for a commitment to high-volume manufacturing and commercialization that will ensure a price of under $2.50 per test for low- and middle-income countries, and for the production of up to 120 million tests each year.
The expanded manufacturing capacity can also be used in the future to make affordable tests for other infectious diseases including during another potential pandemic, FIND and Unitaid said.
This is the first in a series of agreements related to the EOI that will be announced in the coming weeks, the organizations added. The agreements entail plans for technology transfer and scale-up of regional manufacturing capacity for the tests and support further development to enable nasal sampling and enhanced test performance.
Despite the recent introduction of rapid antigen tests, testing capacity remains highly centralized in many countries and is often insufficient to meet the current demand. According to ACT-Accelerator estimates, 500 million COVID-19 diagnostic tests are needed in LMICs during 2021, 75 percent of which must be deployed in decentralized settings including primary healthcare, community-level care, and hospital-triage settings.
In December, FIND announced that the Canadian government had awarded C$20 million (US$15.7 million) to help expand SARS-CoV-2 testing in LMICs.
And in October, the organization said it had been awarded almost $60 million in new funding to accelerate progress in tests and testing capacity for COVID-19.