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Thermo Fisher Scientific Next-Generation SARS-CoV-2 PCR Test Nabs CE-IVD Mark

NEW YORK – Thermo Fisher Scientific announced on Tuesday that its TaqPath COVID-19 Fast PCR Combo Kit 2.0 has received CE-IVD marking.

The test uses eight targets across three genomic regions to ensure accurate detection even with SARS-CoV-2 variants, the company said in a statement. It requires a saliva sample and has a turnaround time of two hours.

"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," Manoj Gandhi, senior medical director of genetic sciences for Thermo Fisher, said in a statement. The company is "future-proofing our test design against likely mutations and to provide continued confidence in their results."

The first generation TaqPath COVID-19 RT PCR Kit, as well as the TaqPath COVID-19 Combo Kit, both used different assay designs. The RT-PCR kit received CE marking in March 2020 and the Combo Kit received Emergency Use Authorization from the US Food and Drug Administration the same month.

In March 2021, the FDA noted that the TaqPath COVID-19 Combo Kit's performance could be negatively impacted by SARS-CoV-2 mutations. It said that the mutations could reduce sensitivity for certain targets of the test but shouldn't decrease overall test sensitivity, although it could affect the interpretation of results.