Privately held Mesa Biotech has developed and commercialized a PCR-based rapid point-of-care testing platform available for detecting infectious diseases including SARS-CoV-2, Influenza A and B, respiratory syncytial virus (RSV) and Strep A. Its patented technology expands the availability of high standard nucleic acid PCR amplification to point-of-care diagnostics.
Mesa Biotech's Accula Flu A/Flu B, RSV and Strep A tests have obtained 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waivers from the U.S. Food and Drug Administration (FDA).
The Accula System has also received Emergency Use Authorization (EUA) from the FDA for SARS-CoV-2 in vitro diagnostic testing and can be used in patient care settings, providing results within 30 minutes, claiming higher accuracy than other rapid tests on the market.
Founded in 2009, Mesa is based in California and has 500 employees with 2020 revenues of around $45m. It will become part of Thermo Fisher’s Life Sciences Solution Segment once the acquisition is completed in the first quarter of 2021, subject to customary closing conditions including regulatory approval.
Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific, said Mesa’s platform will help it ramp up availability of reliable and accurate advanced molecular diagnostics at the point of care. "The addition of Mesa Biotech's easy-to-use, rapid PCR-based test is highly complementary to our existing offering and will further help us meet the continuing demand for COVID-related testing while we work to rapidly scale and develop point-of care tests for other infectious diseases in the future," he said.
Thermo Fisher Scientific’s COVID-19 testing portfolio includes antibody tests launched in October: Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA test, and the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test. The company's response to the pandemic ranges from molecular diagnostic tests and sample collection products to personal protective equipment, and support of therapy and vaccine development and manufacturing.