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 – March 19, 2020 – 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