Since its inception at Los Alamos National Lab, Mesa Biotech has focused on technology well-suited for emergency defense, near-patient testing and rapid response to pandemics, such as SARS, Ebola and now COVID-19
San Diego, CA /PRNewswire/ - Mesa Biotech Inc., a privately-held, molecular diagnostic company has developed an affordable, 30 minute sample-to-answer molecular testing platform designed for point-of-care (POC) infectious disease diagnosis. Today, Mesa Biotech announced it has been awarded a $561K contract from the US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) for development of its rapid molecular diagnostic test for detection of SARS-CoV-2 for 'near patient' testing. The Accula™ SARS-CoV-2 Test will be developed on the company's commercially available platform for Accula Flu A/Flu B and RSV Test, which are both 510(k) cleared and CLIA waived.
"As the coronavirus situation escalates and the demand for testing far exceeds capacity, we are encouraged by the support of HHS in the development of our Accula SARS-CoV-2 Test," said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech Inc. "Our test, which was developed to enable rapid responses to global pandemics, will significantly compress the sample-to-result timeframe with a laboratory-quality test at the point-of-care. This accelerated response will enable health care providers to rapidly screen, isolate, treat or dismiss potential carriers of the virus."
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), under Contract No. 75A50120C00019.
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 (POC). 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 http://www.mesabiotech.com.