Thermo Fisher Scientific Inc. has completed its acquisition of Mesa Biotech, Inc., a privately held point-of-care molecular diagnostic company.
Mesa Biotech has developed the Accula System, a point-of-care PCR-based testing platform for infectious disease diagnosis. The platform enables rapid, highly accurate testing at physician offices, pharmacies and other settings, providing results in 30 minutes. Beyond COVID-19 testing, Mesa Biotech’s existing platform includes tests for flu, respiratory syncytial virus (RSV), and Strep A.
“The Accula System complements our existing offerings and immediately provides our clinical customers with more options and flexibility for COVID-19 testing. And, as the point-of-care diagnostic market expands globally, we’re well-positioned to deliver a broader menu of tests to meet increasing demand,” said Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific.
The Accula Flu A/Flu B, RSV and Strep A tests have 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waivers from the U.S. Food and Drug Administration (FDA). The Flu A/Flu B and RSV assays have also received CE-IVD Mark approval. Additionally, the Accula System has received Emergency Use Authorization (EUA) from the FDA for SARS-CoV-2 in vitro diagnostic testing.
Mesa Biotech will become part of the Life Sciences Solution Segment and is expected to add revenue of approximately $200 million in 2021.