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Cepheid Gets FDA Clearance for Xpert Norovirus Assay

NEW YORK (GenomeWeb) — Cepheid said today that it has received US Food and Drug Administration clearance to market Xpert Norovirus, a qualitative in vitro diagnostic test for the identification and differentiation of norovirus genogroup I (GI) and genogroup II (GII).

Cepheid also said that Xpert Norovirus, as well as Xpert Flu/RSV — which was cleared by FDA last week — have been categorized as moderate complexity tests under CLIA guidelines. All Xpert tests run on Cepheid's GeneXpert system.

Norovirus is highly contagious and is the most common cause of viral gastroenteritis worldwide. Noroviruses can be transmitted from an infected person, contaminated food or water, or by touching contaminated surfaces. According to the US Centers for Disease Control and Prevention, it is the leading cause of disease outbreaks from contaminated food, causes an estimated 21 million illnesses, and contributes to between 56,000 and 71,000 hospitalizations in the US annually.

"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," David Persing, chief medical and technology officer at Cepheid, said in a statement. "Norovirus outbreaks require immediate implementation of targeted infection control procedures, and this new test gives clinicians accurate results in as little as one hour."