The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) announced that it will provide Mesa Biotech, Inc. of San Diego, California, with technical support and $561,330 in immediate funding to seek eventual Food and Drug Administration (FDA) approval or clearance of its COVID-19 diagnostic test. The company will use the funding to complete the work required 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 test requires minimal sample handling, and a 30-minute sample-to-result time.
The Accula COVID-19 test will rely on Mesa Biotech’s Accula Dock instrument that is used with several 510(k)-cleared tests; FDA has classified the Accula Dock influenza point-of-care test as Clinical Laboratory Improvement Amendments (CLIA) waived. The diagnostic test is intended for use in clinical and hospital laboratories and will provide results based on back of the nose and throat swab samples.