FDA Clears Xpert® Norovirus - Accurate Detection in One Hour
Cepheid has received clearance from the FDA to market Xpert® Norovirus, a qualitative in vitro diagnostic test for expeditious identification and differentiation of Noroviruses genogroup I (GI) and genogroup II (GII). Both Xpert Norovirus and the recently cleared Xpert Flu/RSV XC have also been categorized as Moderate Complexity tests. All Xpert tests run on Cepheid's GeneXpert® System, the world's leading molecular diagnostic platform with more than 7,500 systems installed worldwide.
"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, Cepheid's Chairman and Chief Executive Officer. "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, MD, Ph.D., Cepheid's Chief Medical and Technology Officer. "Norovirus outbreaks require immediate implementation of targeted infection control procedures, and this new test gives clinicians accurate results in as little as one hour."
Xpert Norovirus will begin shipping in the United States this month. For more information on Cepheid's GeneXpert Systems or the complete menu of Xpert tests, visit www.cepheid.com.
Date Published: December 8, 2014
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