The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will provide Mesa Biotech with technical expertise and up to $561,330 in immediate funding in support of its novel coronavirus disease (COVID-19) diagnostic test.
This funding from BARDA will support the development efforts required for Mesa Biotech to submit a request to the U.S. Food and Drug Administration (FDA) for potential Emergency Use Authorization (EUA) of the Accula COVID-19 point-of-care test.
The Accula COVID-19 test will leverage Mesa Biotech’s Accula Dock instrument that has been 510(k)-cleared and Clinical Laboratory Improvement Amendments (CLIA)-waived by the FDA for influenza point-of-care testing. Utilizing the Accula Dock, the new Accula COVID-19 test will provide molecular results for COVID-19 within 30 minutes from throat, nasal, or nasopharyngeal swab samples. The diagnostic test is intended for use in clinical and hospital laboratories. BARDA continues to work with its industry partners to develop rapid diagnostic tests for COVID-19.
This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.
Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care. The company’s patented system enables healthcare professionals to access actionable, laboratory-quality results at the point-of-care with greater sensitivity and specificity than current infectious disease rapid immunoassay tests.