On Mar. 19, 2020, Mesa Biotech announced it has significantly expanded its capacity to test clinical samples for SARS-CoV-2, the virus that causes COVID-19. With new equipment that went online Tuesday, Mayo Clinic Laboratories now has the capacity to process COVID-19 test samples from all Mayo Clinic sites. In addition, it has begun processing test samples from its clients across Minnesota, including eight major health systems.

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 US 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 (e.g. temporary screening facilities, physician office labs (POL), urgent care, cruise ships, long term skilled nursing facilities), 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 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. 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.

This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA)