FDA grants clearance for Cepheid to market Xpert Norovirus diagnostic test

2 December 2014 (Last Updated December 2nd, 2014 18:30)

The US Food and Drug Administration (FDA) has granted clearance for US-based molecular diagnostics firm Cepheid to market Xpert Norovirus.

The US Food and Drug Administration (FDA) has granted clearance for US-based molecular diagnostics firm Cepheid to market Xpert Norovirus.

Xpert Norovirus is a qualitative in vitro diagnostic test for expeditious identification and differentiation of Noroviruses genogroup I (GI) and genogroup II (GII).

Norovirus is a highly contagious virus, which can be transmitted from an infected person, contaminated food or water and by touching contaminated surfaces.

Cepheid said both Xpert Norovirus and the recently cleared Xpert Flu / RSV XC were categorised as moderate complexity tests.

According to Centers for Disease Control and Prevention, Norovirus is the leading cause of disease outbreaks from contaminated food and causes an estimated 21 million illnesses.

"Both Xpert Norovirus and the recently cleared Xpert Flu / RSV XC were categorised as moderate complexity tests."

The virus contributes to between 56,000 and 71,000 hospitalisations in the US annually.

Cepheid chairman John Bishop said: "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.

"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."

The company said Xpert Norovirus will begin shipping in the US this month.

Cepheid chief medical and technology officer Dr David Persing said: "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.

"Norovirus outbreaks require immediate implementation of targeted infection control procedures, and this new test gives clinicians accurate results in as little as one hour."