The Department of Health and Human Services (HHS) will provide Mesa Biotech with technical expertise and $561,330 in immediate funding to pursue eventual Food and Drug Administration (FDA) approval or clearance of its diagnostic test to detect COVID-19 infections, according to the department’s press release.
The support comes from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR).
With BARDA’s support, the company can complete the development work necessary to request Emergency Use Authorization (EUA) from the FDA for the Accula COVID-19 point-of-care test within two months of the award. The Accula COVID-19 diagnostic test requires minimal sample handling, and a 30-minute sample-to-result time, HHS said.
The diagnostic test is intended for use in clinical and hospital laboratories.
Mesa Biotech’s test is the fourth COVID-19 molecular diagnostic to receive development funding from BARDA.
“Diagnostics are a critical need in the overall strategy to fight this newest global public health threat. 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,” said BARDA Director Rick A. Bright, PhD.
The Accula COVID-19 test will leverage Mesa Biotech’s Accula Dock instrument that is used with several 510(k)-cleared tests. The FDA has categorized the Accula Dock influenza point-of-care test as Clinical Laboratory Improvement Amendments (CLIA) waived. Utilizing the Accula Dock, the new test will provide molecular results indicating the presence of the virus based on nasopharyngeal (back of the nose and throat) swab samples.
