Mesa Biotech Receives Emergency Use Authorization from FDA for a 30 Minute Point of Care Molecular COVID-19 Test

Mesa Biotech announced it has 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 Inc., 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.

“Mesa is excited to immediately begin shipping our rapid, molecular SARS-CoV-2 test so people can get answers in 30 minutes. Our Accula system is easy to use and fits in the palm of your hand. This allows many units to be run side by side in the doctor’s office further increasing the speed of COVID-19 diagnosis. Accula provides a true decentralized testing solution for COVID-19 at the point of care,” said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. “Our test will provide a highly accessible means for healthcare professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat or dismiss potential carriers of the virus. The potential to reduce the growing strain on our nation’s hospitals is tremendous.”

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.

About Mesa Biotech Inc.

Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care. Mesa Biotech’s Accula™ Flu A/Flu B and RSV tests have obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA). Both products are distributed in the United States by Sekisui Diagnostics under the Silaris™ brand. Mesa Biotech has also secured a number of strategic agreements for distribution in Europe and Asia. For more information visit

Source: Mesabiotech


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