NEW YORK – Mesa Biotech has been awarded $561,330 from the Biomedical Advanced Research and Development Authority to support development and commercialization of a point-of-care diagnostic test for SARS-CoV-2, the pathogen that causes coronavirus disease COVID-19.
The firm's test runs on its Accula platform, requires minimal sample handling, and produces a result in 30 minutes. An influenza test on the system was previously cleared by the US Food and Drug Administration and CLIA waived.
The funding was awarded through the EZ-BAA mechanism of BARDA, which is part of the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, or ASPR.
BARDA will provide San Diego-based Mesa Biotech with the funding as well as technical expertise, with the intention that the firm attain Emergency Use Authorization from the US Food and Drug Administration in two months. Mesa has previously disclosed that it has been working on a SARS-CoV-2 test and is conducting clinical validations through a collaboration in China.
"Diagnostics are a critical need in the overall strategy to fight this newest global public health threat," said Rick Bright, director of BARDA, in a statement. "We need increased testing capacity in the US to rapidly identify, isolate, and treat those infected with COVID-19 in order to limit transmission of the virus, and we need those tests as close to the patients as possible."
The Accula platform is distributed exclusively in the US by Sekisui, under the brand name Silaris.