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FDA approves Xpert norovirus on-demand molecular test

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The manufacturer of Xpert Norovirus, the first on-demand molecular test for detection of norovirus, has received FDA clearance to market the test, according to a press release.

Xpert Norovirus (Cepheid) is a qualitative in vitro diagnostic test that identifies norovirus in as little as 1 hour and differentiates between genogroups I and II, according to the release. The test runs on Cepheid’s GeneXpert System platform.

“Norovirus exposure is an unfortunate fact of life,” John Bishop, chairman and CEO of Cepheid, said in the press release. “The associated illness can spread quickly in the hospital setting and be very serious, especially in young children and older adults. To actively manage the infection, clinicians have previously been forced to choose between accuracy and time-to-result when selecting a testing method — now no compromise is required as Xpert Norovirus delivers both.”

Xpert Norovirus will begin shipping in the United States this month, according to the release.