Thermo Fisher Scientific : Introduces Rapid Point-of-Care RT-PCR Flu A/Flu B Test

Accula Flu A/Flu B Test provides PCR results in about 30 minutes

SAN DIEGO, Calif., Nov. 16, 2022 - Thermo Fisher Scientific, the world leader in serving science, has introduced the rapid RT-PCR Accula Flu A/Flu B Test designed to enable healthcare providers to detect and differentiate influenza A and B in about 30 minutes. The test can guide treatment at the point of care, including at a physician's office, urgent care center or pharmacy, as well as help providers improve patient flow, reduce the need for follow up visits and shorten wait times.

"Healthcare providers across the United States have trusted the Accula SARS-CoV-2 Test* for rapid, accurate COVID-19 test results and can now rely on the Accula Flu A/Flu B Test for their point-of-care testing needs as we enter the flu season and beyond," said Ingo Chakravarty, vice president and general manager of rapid diagnostics solutions at Thermo Fisher Scientific. "With this launch, we are well on our way to becoming a true point-of-care testing provider. We look forward to continuing to expand our menu of rapid test offerings for the Accula platform."

The Accula Flu A/Flu B Test provides an easy-to-read visual result and delivers the accuracy of RT-PCR tests, combined with the simplicity of antigen tests. It runs on the palm-sized, portable Accula Dock, which plugs into a standard wall outlet to enable RT-PCR testing without the need for a specialized laboratory.

Thermo Fisher Scientific acquired Mesa Biotech, the company that developed and commercialized the Accula platform, in 2021. The Accula Dock and Accula Flu A/Flu B test received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waived status in 2018 from the Food & Drug Administration (FDA).

For more information, please visit www.thermofisher.com/accula.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 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, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team 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, Patheon and PPD. For more information, please visit www.thermofisher.com

* The Accula SARS-CoV-2 Test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; The Accula SARS-CoV-2 Test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and the emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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 declaration is terminated or authorization is revoked sooner.

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