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September 15, 2021

FDA grants EUA to Cepheid’s rapid Covid-19/Flu/RSV diagnostic test

Xpert Xpress CoV-2/Flu/RSV plus works on Cepheid’s GeneXpert Systems and offers results in nearly 36 minutes.

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Cepheid’s rapid molecular diagnostic test, Xpert Xpress CoV-2/Flu/RSV plus.

The test is indicated for qualitative identification of the viruses that cause Covid-19, Flu A, Flu B and respiratory syncytial virus (RSV) infections in a single patient sample.

The latest plus version of the test offers a third gene target for the SARS-CoV-2 virus in order to boost the potential for identifying any viral mutations in the future.

Several variants of the SARS-CoV-2 virus have been detected across the globe during the pandemic.

As viruses frequently change through mutation, new viral variants are anticipated to arise over time.

Cepheid noted that including a third gene target to the plus version of the CoV-2/Flu/RSV test offers extensive coverage to alleviate the potential impact of viral genetic drift in the future.

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Xpert Xpress CoV-2/Flu/RSV plus can be used on any of Cepheid’s GeneXpert Systems, of which there are more than 35,000 available globally, and offers results in nearly 36 minutes.

Cepheid chief medical and technology officer Dr David Persing said: “This respiratory season, healthcare providers may encounter a range of viral infections with symptoms that overlap with Covid-19, including Flu A, Flu B and respiratory syncytial virus.

“Having a fast and accurate test that is designed to detect current and future variants of the viruses that cause Covid-19 and influenza will become increasingly important.

“The ability to collect one sample and run a single, highly-sensitive multiplexed test that detects and differentiates all four viruses will provide actionable results to inform better front-line decisions within our healthcare systems.”

The company noted that the new test is authorised only to qualitatively identify and distinguish nucleic acid from SARS-CoV-2, influenza A virus, influenza B virus and RSV, simultaneously, and not any other viruses or pathogens.

Cepheid anticipates commencing shipping of Xpert Xpress CoV-2/Flu/RSV plus to users in the US in the coming weeks.

In July, Cepheid obtained CE-IVD clearance for two advanced, extended-coverage human immunodeficiency virus tests, Xpert HIV-1 Viral Load XC and Xpert HIV-1 Qual XC.

Xpert HIV-1 Viral Load XC is indicated for analysing the viral load levels that are used for monitoring the antiretroviral treatment efficiency.

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