The U.S. Department of Health and Human Services (HHS) this week announced additional actions to support the development of a novel coronavirus diagnostics.
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.
DiaSorin Molecular, LLC of Cypress, California will also receive BARDA’s technical assistance and $697,000 for the development of the Simplexa™ COVID-19 Direct assay, a molecular test for qualitative identification of the novel coronavirus SARS-CoV-2 which causes COVID-19.
DiaSorin received Emergency Use Authorization (EUA) from the FDA on March 19 for their COVID-19 Direct kit. DiaSorin will begin shipping kits for immediate use in laboratories across the US this week.
DiaSorin’s test will use a nasopharyngeal (back of the nose and throat) swab from patients and is designed for use with the company’s Simplexa™ Direct technology, a diagnostic platform currently used for their influenza and Respiratory Syncytial Virus (RSV) tests that have been cleared by the FDA.
The COVID-19 test would run on DiaSorin’s LIAISON® MDX instrument, which works in conjunction with LIAISON® MDX Studio software not only in reference laboratories, but also in labs that are closer to the patient, such as hospital labs. This technology uses a sample-to-answer approach with minimal operator input, yielding results in about 90 minutes. Hundreds of the company’s diagnostic devices are in use in large commercial, hospital, and public health laboratories around the country.
Sources: Medicalcountermeasures.gov, HHS.gov, FDA.gov
