Thermo Fisher Launches CE-IVD-Marked Next-Generation TaqPath COVID-19 2.0 Test

(Waltham, MA, USA) has launched a new CE-IVD-marked COVID-19 test named the TaqPath COVID-19 Fast PCR Combo Kit 2.0., expanding its menu of highly accurate tests that detect active SARS-CoV-2 infections.

The kit uses an advanced assay design which 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. 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.

"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."

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