In the expanding efforts to find a solution to testing efforts against COVID-19, the Biomedical Advanced Research and Development Authority (BARDA) has provided $561,330 to Mesa Biotech, Inc. for development of a new diagnostic test.
This funding — along with technical expertise — will help Mesa Biotech pursue eventual Food and Drug Administration approval for their test under Emergency Use Authorization. BARDA believes this could be achieved within two months of the award. The test — the Accula COVID-19 diagnostic — proposes to achieve a 30-minute turnaround from sampling to result, with minimal handling involved. If successful, it would represent a massive upturn in the testing time scale.
The Accula test will utilize Mesa Biotech’s Accula Dock instrument already used in several 510(k)-cleared tests. It will provide molecular results based on swab samples from the back of the nose and throat and could be used in either clinical or hospital labs.
“Diagnostics are a critical need in the overall strategy to fight this newest global public health threat,” BARDA Director Rick Bright said. “We need increased testing capacity in the U.S to rapidly identify, isolate, and treat those infected with COVID-19 in order to limit transmission of the virus, and we need those tests as close to the patients as possible. This partnership is the latest example of our strong commitment to make diagnostic tests available as quickly and broadly as possible for Americans. We are working tirelessly to advance multiple diagnostics to EUA status so healthcare providers can rapidly diagnose and treat patients with COVID-19.”
Shortages of tests have been an ongoing issue throughout the U.S. response to the growing COVID-19 pandemic. Without tests, the government cannot even accurately assess the landscape and diagnose COVID-19 infections, let alone mitigate its spread. Accula represents the fourth COVID-19 molecular diagnostic to win development funding from BARDA at this time, provided through the EZ-BAA application process.
Currently, there are no diagnostics, vaccines, or treatments for COVID-19 approved by the U.S. Food and Drug Administration.