Research & Development
Mesa Biotech granted FDA Emergency Use Authorization for 30 minute POC molecular COVID-19 Test
25 March 2020 -

Molecular diagnostic test provider Mesa Biotech announced on Tuesday the receipt of US Food & Drug Administration (FDA) Emergency Use Authorization (EUA) for its Accula SARS-CoV-2 Test that provides the COVID-19 diagnostic results in 30 minutes.

According to the company, it has developed an affordable, easy to use testing platform designed for point-of-care (POC) infectious disease diagnosis. The COVID-19 test uses this patented technology to enable 'near patient' testing allowing testing outside of the central laboratory.

The company said Accula SARS-CoV-2 Test is a visually read test using polymerase chain reaction (PCR) technology to detect SARS-CoV-2 (the virus responsible for COVID-19) via throat and nasal swab samples. The test is designed for the point-of-care use, temporary screening facilities, physician office labs, urgent care and long term nursing facilities and complements the tests performed in central laboratories.

Mesa Biotech added that its technology was developed at Los Alamos National Lab supported by NIH grants from the National Institute of Allergy and Infectious Diseases and the Western Regional Centers for Excellence in Biodefense and Emerging Infectious Disease program.

Last week, the company received funding from the US Health and Human Services for development of its SARS-CoV-2 test.