On Mar. 24, 2020, Mesa Biotech announced it had received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for its Accula™ SARS-CoV-2 Test, which gives COVID-19 diagnostic results in 30 minutes.

Mesa Biotech, a privately-held, molecular diagnostic company 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 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. Similar to Mesa Biotech’s commercially available tests for influenza and RSV, the Accula SARS-CoV-2 Test is designed for the point-of-care use, including temporary screening facilities, physician office labs, urgent care, and long term nursing facilities. The system complements central laboratories where current testing is performed. Mesa Biotech’s compact coronavirus test yields laboratory-quality results in approximately 30 minutes.

Mesa Biotech’s technology was developed at Los Alamos National Lab 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. Last week, the company received funding from the U.S. Health and Human Services for development of its SARS-CoV-2 test.

Since its inception, the company has focused on technology well-suited for emergency defense and rapid deployment for SARS, Ebola and other emerging infectious diseases. Mesa Biotech’s platform was specifically designed for use outside the lab to enable rapid responses to global pandemics, such as COVID-19.