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www.fdanews.com/articles/204038-thermo-fisher-gets-euas-for-two-more-covid-19-tests
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Thermo Fisher Gets EUAs for Two More COVID-19 Tests

August 19, 2021

The FDA has granted Thermo Fisher Scientific emergency use authorizations for two COVID-19 assays designed to accurately identify new variant strains of the SARS-CoV-2 virus.

The new EUAs cover the TaqPath COVID-19 fast polymerase chain reaction (PCR) combo kit 2.0 and the TaqPath COVID-19 RNase PCR combo kit 2.0, which were “designed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants,” the company says.

The updated kits target eight different genes across three regions of the SARS-CoV-2 virus, to ensure the accuracy of the test results in situations where gene expression in the virus varies as new mutations emerge.

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