Thermo Fisher Scientific launches CE-IVD-marked COVID-19 test

Thermo Fisher Scientific, the world leader in serving science, has announced the launch of a new CE-IVD-marked COVID-19 test. The TaqPath COVID-19 Fast PCR Combo Kit 2.0. expands Thermo Fisher's menu of highly accurate tests that detect active SARS-CoV-2 infections.

The kit uses an advanced assay design that compensates for current and emerging variants by using eight total targets across three genomic regions of the virus. This approach helps to ensure the test provides accurate results even as the virus that causes COVID-19 continues to mutate.

"COVID-19 variants can be more transmissible and potentially impact efficacy of diagnostics, vaccines and therapies, threatening to reverse progress made in the past year," said Manoj Gandhi, M.D., Ph.D., senior medical director, genetic sciences for Thermo Fisher. "We are working to empower our customers to prepare for the next stage of the pandemic by future-proofing our test design against likely mutations and to provide continued confidence in their results."

The TaqPath COVID-19 Fast PCR Combo Kit 2.0 test assesses raw saliva directly with a turnaround time of two hours to enable widespread, high-frequency testing. The first generation TaqPath COVID-19 CE-IVD RT PCR Kit and the TaqPath COVID-19 Combo Kit, which use a different assay design, respectively, received initial CE-IVD certification and Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) in March 2020.

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