Rapid Norovirus Assay Approved for Diagnostic Use in the United States

A dedicated laboratory-in-a-cartridge assay that enables the rapid diagnosis of norovirus infection has been approved for use in the United States.

The Food and Drug Administration (FDA) approved the single use Xpert Norovirus assay, which runs on Cepheid's (Sunnyvale, CA, USA) GeneXpert System, one of the world's leading molecular diagnostic platforms with more than 7,000 systems installed to date. The Xpert Norovirus assay is a qualitative in vitro diagnostic test for rapid identification and differentiation of noroviruses genogroup I (GI) and genogroup II (GII).

Cepheid's GeneXpert System is a closed, self-contained, fully-integrated, and automated platform that combines on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect, and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples.

"Norovirus exposure is an unfortunate fact of life. The associated illness can spread quickly in the hospital setting and be very serious, especially in young children and older adults," said John Bishop, CEO of Cepheid. "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 enables on-demand molecular detection and differentiation of the GI and GII Norovirus genogroups, which together account for the vast majority of human infections," said Dr. David H. Persing, CMO and CTO at Cepheid. "Norovirus outbreaks require immediate implementation of targeted infection control procedures, and this new test gives clinicians accurate results in as little as one hour."

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