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Thermo Fisher Scientific Gets FDA EUA for COVID-19, Influenza Combo PCR Test

NEW YORK – Thermo Fisher Scientific said on Tuesday that it has obtained Emergency Use Authorization from the US Food and Drug Administration for a multiplex real-time PCR test for COVID-19 and influenza.

The Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit can detect and differentiate RNA from SARS-CoV-2, influenza A, and influenza B viruses using nasopharyngeal or nasal swab samples.

The kit includes the Applied Biosystems Pathogen Interpretive Software, which converts genetic analysis data into a report. Use of the kit is limited to laboratories that are CLIA-certified to perform high-complexity tests and to similarly qualified non-US laboratories.

COVID-19 and the flu "are illnesses which can present with similar clinical symptoms, but for which patient management, including quarantining measures, greatly differs," said Mark Smedley, president of genetic sciences at Thermo Fisher Scientific, in a statement. "This new kit offers clinical and public health laboratories a single test to help diagnose and monitor the spread of COVID-19 and the flu."

In December, the company already obtained the CE mark for another multiplex PCR kit, called TaqPath COVID-19, Flu A/B, RSV Combo kit, which includes one more pathogen, respiratory syncytial virus.

Last March, Thermo Fisher also obtained EUA for its TaqPath COVID-19 Combo Kit and the CE mark for its TaqPath-19 RT-PCR kit. Earlier this month, it received the CE mark for its Applied Biosystems TaqPath COVID-19 HT kit, a high-throughput version of the CE-marked test.