Research & Development
Cepheid wins FDA's EUA for Xpert Xpress CoV-2/Flu/RSV plus to enhance detection of future SARS-CoV-2 variants
15 September 2021 -

Molecular diagnostics company Cepheid reported on Tuesday the receipt of US Food & Drug Administration (FDA) Emergency Use Authorization (EUA) for Xpert Xpress CoV-2/Flu/RSV plus, for the qualitative detection of the viruses causing COVID-19, Flu A, Flu B and respiratory syncytial virus (RSV) infections from a single patient sample.

The company said the new plus version of the diagnostics test provides a third gene target for SARS-CoV-2 detection to meet the challenge of future viral mutations. Multiple variants of the virus that causes COVID-19 have been documented globally during the pandemic.

According to the company, the Xpert Xpress CoV-2/Flu/RSV plus is designed for use on any of its over 35,000 GeneXpert Systems placed worldwide, with results delivered in approximately 36 minutes.

In addition, the company's Xpert Xpress CoV-2/Flu/RSV plus is expected to begin shipping to US customers in the next few weeks.

Viruses constantly change through mutation, and new variants of a virus are expected to occur over time. Adding a 3rd gene target to the plus version of the company's CoV-2/Flu/RSV test delivers broader coverage to mitigate the possible effects of future viral genetic drift.



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