Cepheid Receives FDA Clearance for Xpert Norovirus

Cepheid announces that it has received clearance from the Food and Drug Administration (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, a leading molecular diagnostic platform with more than 7,500 systems installed worldwide.

Norovirus is a highly contagious virus 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. Nausea, vomiting, watery diarrhea, and abdominal pain characterize infection. Globally, the virus affects approximately 267 million people and causes over 200,000 deaths each year.(1) 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.(2)

"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," says John Bishop, Cepheid's chairman and CEO. "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," says David H. Persing, MD, PhD, 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.

References
1. Patel MM, Widdowson MA, Glass RI, Akazawa K, Vinje J, et al. (2008) Systematic literature review of role of noroviruses in sporadic gastroenteritis. Emerg Infect Dis 14: 1224–1231. doi: 10.3201/eid1408.071114  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2600393/
2. Centers for Disease Control and Prevention. Norovirus Overview. Accessed Nov 4, 2014. http://www.cdc.gov/norovirus/about/overview.html

Source: Cepheid