- Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced it has completed its previously announced acquisition of Mesa Biotech, Inc., a privately held point-of-care molecular diagnostic company.
"Mesa Biotech is an important part of our strategy to expand the benefits of molecular diagnostics at the point of care, starting with COVID-19 testing," said Mark Stevenson , executive vice president and chief operating officer of Thermo Fisher Scientific. "By combining Thermo Fisher's operational excellence, access to raw materials and existing distribution and sales channels with Mesa's innovative platform, we can rapidly scale manufacturing volume, drive cost efficiencies and bring much-needed diagnostics to market faster and at greater scale."
Mesa Biotech has developed the Accula System, an affordable, easy-to-use, 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," Stevenson continued.
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.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion . Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .
This press release contains forward-looking statements that involve a number of risks and uncertainties. Important factors that could cause actual results to differ materially from those indicated by forward-looking statements include risks and uncertainties relating to: the duration and severity of the COVID-19 pandemic; the need to develop new products and adapt to significant technological change; implementation of strategies for improving growth; general economic conditions and related uncertainties; dependence on customers' capital spending policies and government funding policies; the effect of economic and political conditions and exchange rate fluctuations on international operations; use and protection of intellectual property; the effect of changes in governmental regulations; and the effect of laws and regulations governing government contracts, as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected. Additional important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in our most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q, which are on file with the Securities and Exchange Commission and available in the "Investors" section of our website under the heading "SEC Filings." While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if estimates change and, therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.
*The Accula SARS-CoV-2 Test has not been FDA cleared or approved; it has been authorized by FDA under an EUA for use by CLIA-certified laboratories that meet requirements to perform high, moderate or waived complexity tests. It is also authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The Accula SARS-CoV-2 Test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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SOURCE Thermo Fisher Scientific