Molecular diagnostic company Mesa Biotech Inc reported on Thursday the receipt of a USD561,000 contract from the US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) for the development of its rapid molecular diagnostic test for detection of SARS-CoV-2, the virus that causes COVID-19, for 'near patient' testing subject to clearance.
The company's SARS-CoV-2 test will be developed on its commercially available platform for Accula Flu A/Flu B and RSV Test, which are both 510(k) cleared and CLIA waived.
In connection with the award, the company has submitted its SARS-CoV-2 test to the Food and Drug Administration (FDA) to be considered for Emergency Use Authorization (EUA). The molecular point-of-care coronavirus test will enable laboratory-quality results in about 30 minutes.
The Accula SARS-CoV-2 Test will be a qualitative, visually read test utilizing polymerase chain reaction (PCR) technology to detect SARS-CoV-2 via throat swab samples. The molecular technology was supported by NIH grants from the National Institute of Allergy and Infectious Diseases (NIAID) and the Western Regional Centers for Excellence in Biodefense and Emerging Infectious Disease program.
According to the company, the Accula Flu A/Flu B and RSV tests have obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the US Food and Drug Administration (FDA).
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