BARDA will support Mesa Biotech, Inc. in the development of a rapid combination test for influenza A/B and COVID-19. The new AcculaTM SARS-CoV-2 & Flu A/Flu B Combination Test will provide results in approximately 30 minutes and is performed using the same Accula instrument as the company’s Flu A/Flu B test and SARS-CoV-2 test.
The Accula FluA/Flu B test is U.S. Food and Drug Administration (FDA) 510(k) cleared. In March, BARDA began supporting development of the Accula SARS-COV-2 test and the test received FDA Emergency Use Authorization later that month. Both tests are currently Clinical Laboratory Improvement Amendments (CLIA)-waived for point-of-care use.
Combining assays for Flu A/Flu B and SARS-CoV-2 into a single test will allow health care providers to rapidly distinguish influenza from SARS-CoV-2 using throat, nasal, or nasopharyngeal swab samples and will facilitate proper treatment and reduce impact of seasonal influenza testing on stressed infrastructure.
BARDA continues to work with its industry partners to develop rapid diagnostic tests for COVID-19. This additional BARDA support aids in development efforts required for Mesa Biotech to request FDA’s emergency use authorization of the Accula SARS-CoV-2 & Flu A/Flu B Combination Test and to seek 510(k) clearance for this new combination test.
About Mesa Biotech:
The following information is provided by company and does not indicate endorsement by the federal government of the company or its products.
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.