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March 23, 2020

US FDA grants EUA for Cepheid’s SARS-CoV-2 test

Cepheid has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its rapid molecular diagnostic test, Xpert Xpress SARS-CoV-2.


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Cepheid has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its rapid molecular diagnostic test, Xpert Xpress SARS-CoV-2.

The test is designed for the qualitative detection of SARS-CoV-2 virus, which causes coronavirus (Covid-19) disease.

Designed to operate on the company’s automated GeneXpert Systems, it has a detection time of approximately 45 minutes.

Cepheid chief medical and technology officer Dr David Persing said: “By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and potential future variants of SARS-CoV-2, we have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly.”

The company has more than 23,000 automated GeneXpert Systems worldwide.

It currently has approximately 5,000 GeneXpert Systems in the US that are capable of point-of-care testing and suitable for hospital use.

Commenting on the new development, Cepheid president Warren Kocmond said: “Our automated systems do not require users to have specialty training to perform testing. They are capable of running 24/7, with many systems already doing so today.”

Cepheid is a molecular diagnostics company within Danaher Corporation’s diagnostics platform. The company focuses on developing, manufacturing and marketing accurate yet easy-to-use molecular systems and tests.

Meanwhile, the US FDA recently relaxed regulations around diagnostics for Covid-19 to expedite the availability of testing.

It has granted EUA to a number of coronavirus tests, including Abbott’s molecular test and Roche’s Cobas SARS-CoV-2.

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