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Cepheid’s Xpert Norovirus Test Gets Green Light from FDA

Cepheid, a molecular diagnostics company, recently received clearance from the U.S Food and Drug Administration to market its Xpert Norovirus test.

The diagnostic test provides rapid diagnosis of Noroviruses in genogroup I and genogroup II.

“Norovirus exposure is an unfortunate fact of life,” Cepheid Chairman and CEO John Bishop said. “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.”

Norovirus is a highly contagious virus and is the most common cause of viral gastroenteritis worldwide. Afflicting an estimated 21 million people annually, Norovirus is transmitted by contact with contaminated food and water, infected persons or contaminated surfaces.

“Xpert Norovirus enables on-demand molecular detection and differentiation of the GI and GII Norovirus genogroups, which together account for the vast majority of human infections,” Dr. David H. Persing, chief medical and technology officer at Cepheid, said. “Norovirus outbreaks require immediate implementation of targeted infection control procedures and this new test gives clinicians accurate results in as little as one hour.”

The Xpert Norovirus tests will begin shipping within the United States this month.

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