Cepheid Gets Clearance From FDA To Market Xpert Norovirus - Quick Facts

(RTTNews) - Molecular diagnostics company Cepheid, Inc. (CPHD) said it has received clearance from the U.S. Food & Drug Administration or FDA to market Xpert Norovirus, a qualitative in vitro diagnostic test for expeditious identification and differentiation of Noroviruses genogroup I (GI) and genogroup II or 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. Xpert Norovirus would begin shipping in the U.S. this month.

Norovirus, a highly contagious virus, 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. Nausea, vomiting, watery diarrhea, and abdominal pain characterize infection.

Worldwide, the virus affects nearly 267 million people, causing over 200,000 deaths every year. According to the Centers for Disease Control and Prevention, Norovirus 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 U.S. each year.