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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.”
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By GlobalDataThe 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.
