FDA Gives Nod to Cepheid’s Norovirus Diagnostic

The FDA has given Cepheid clearance to market its Xpert Norovirus in vitro diagnostic, categorizing it as a Moderate Complexity test, the company said Monday. The first shipments are due to go out this month.

The test identifies and differentiates between genogroup I and II Noroviruses and runs on the company’s GeneXpert System, Cepheid added.

“Xpert Norovirus allows for on-demand molecular detection and differentiation of the GI and GII Norovirus genogroups, which together account for the vast majority of human infections," said David H. Persing, chief medical and technology officer at Cepheid. Outbreaks need to be controlled immediately, and the test, which gives results in as little as one hour, helps to speed up that process, he added.

Norovirus is the most common cause of viral gastroenteritis worldwide, affecting 267 million people globally and causing 200,000 deaths each year. It can be transmitted by infected people, contaminated food or water, or by touching contaminated surfaces, the Sunnyvale, Calif., company said. — Kellen Owings

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