SAN DIEGO—Today, Mesa Biotech, Inc. announced that it has been awarded a $561K contract from the U.S. Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) for development of its rapid molecular diagnostic test for detection of SARS-CoV-2 for near patient testing. The Accula SARS-CoV-2 test will be developed on the company’s commercially available platform for Accula Flu A/Flu B and RSV test, which are both 510(k) cleared and CLIA waived.
“As the coronavirus situation escalates and the demand for testing far exceeds capacity, we are encouraged by the support of HHS in the development of our Accula SARS-CoV-2 Test,” said Hong Cai, co-founder and chief executive officer of Mesa Biotech Inc. “Our test, which was developed to enable rapid responses to global pandemics, will significantly compress the sample-to-result timeframe with a laboratory-quality test at the point-of-care. This accelerated response will enable health care providers to rapidly screen, isolate, treat or dismiss potential carriers of the virus.”
Mesa Biotech’s Accula SARS-CoV-2 molecular point-of-care diagnostic for COVID-19 has been selected for development through BARDA, which is part of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response. Mesa Biotech has submitted its SARS-CoV-2 test to the Food and Drug Administration (FDA) to be considered for Emergency Use Authorization (EUA).
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. Similar to Mesa Biotech’s existing tests, the Accula SARS-CoV-2 test is designed for the point-of-care, complementing the central laboratories where current testing is performed. Mesa Biotech’s molecular POC coronavirus test, subject to regulatory approval, will enable laboratory-quality results in approximately 30 minutes.
Mesa Biotech’s molecular technology was developed at Los Alamos National Lab, supported by 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. Mesa Biotech’s platform was specifically designed for use outside the lab to enable rapid responses to global pandemics, such as COVID-19.