Los Alamos National Laboratory-based COVID-19 Test Receives Emergency Use Authorization from the FDA

Mar 24, 2020 | Coronavirus, COVID-19, Diagnostic, FDA Emergency Use Authorization, Investor Watch, Los Alamos National Laboratory, News, Point-of-Care Test

Los Alamos National Laboratory-based COVID-19 Test Receives Emergency Use Authorization from the FDA

San Diego-based Meso Biotech received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Accula™ SARS-CoV-2 Test, which purportedly generates COVID-19 diagnostic results in 30 minutes. Apparently affordable and designed for the “point-of-care,” this technology will contribute to more testing coverage, which will help ultimately contain and stop the pandemic.

TrialSite News offers its standard question and answer-driven breakdown of this venture and technology.

Who is Mesa Biotech?

A privately-held molecular diagnostic company founded in 2009 to simplify DNA testing. The company designs, develops, manufactures and commercializes next-generation molecular diagnostic tests, bringing what they position to be superior diagnostic performance of nucleic acid PCR amplification to the point-of-care. Their Accula™ System consists of a portable, palm-sized dock and assay-specific test cassettes. The patented system supports healthcare professionals to access actionable, laboratory-quality results at the point-of-care with greater sensitivity and specificity than current infectious disease rapid immunoassay tests. Mesa’s product (Accula Flu A/Flu B and the Accula RSV tests) have obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the FDA. 

Where are their offices?

They are headquartered in San Diego, a biotech cluster and run a satellite office in Santa Fe, New Mexico near the Los Alamos National Laboratory where the two founders worked together for thirteen years.

Who are its Founders?

The company’s founders Hong Cai (CEO) and Bruce Cary (VP) bring incredible experience to this important diagnostic marketplace—the COVID-19 highlights the imperative need for economical and compelling point-of-care testing capacity. Founder Ms. Cai spent more than 20 years in the field of molecular biology, including 13 years at the prestigious Los Alamos National Laboratory managing leading projects for nucleic acid assays for forensic analysis among other activities. Ms. Cai undoubtedly developed powerful relationships with that government-funded operation. And the inventor of their product line, Bruce Cary also spent 13 years at Los Alamos alongside Ms. Cai.

How much money has the Venture raised?

The company has raised $13 million (grants and investment for equity) in at least three investment rounds, according to website Pitchbook. Investors or those that have awarded grants to the company include the U.S. Department of Health and Human Services (for COVID-19), NIH, NIAID, New Mexico Venture Acceleration Fund, Bill & Melina Gates Foundation and California Citrus Research Board.

The company’s last $3 million round brought on new board members, including William Brody formerly with San Diego’s Salk Institute for Biological Studies where he led them to triple its endowment and created 19 endowed professorships over his six-year tenure, not to mention establishing the conditions and culture to attract a new generation of world leading researchers. Their board also includes local financial advisor Eric Sagerman

What are the Product’s Features?

The Accula SARS-CoV-2 Test produces a COVID-19 diagnostic result in 30 minutes. A polymerase chain reaction (PCR)-based testing technology—the tests are read via throat and nasal swab samples. The system is designed for point-of-care use, including temporary screening facilities, physician office labs, urgent care and long-term nursing facilities. It can complement central laboratories when current testing is performed.

Where was the technology originally developed?

Los Alamos National Laboratory thanks to grants from the National Institutes of Health (NIH)-based National Institute of Allergy and Infectious Diseases (NIAID) and the Western Regional Centers of Excellence in Biodefense and Emerging Infectious Disease Program.

Call to Action: The FDAs EUA potentially makes this San Diego-based privately -held venture far more valuable. Hence, they are placed on the TrialSite News‘ “Investor Watch.”


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