FDA News

FDA okays Xpert EV test for meningitis

(March 19, 2007)--Cepheid announced it received clearance from the FDA to market its Xpert EV test, which runs on the GeneXpert System, for the presumptive qualitative detection of enterovirus RNA in cerebrospinal fluid (CSF) as an aid in the laboratory diagnosis of enterovirus infection in patients with a clinical suspicion of meningitis. The Xpert EV test, designed to detect enterovirus (EV) RNA in CSF by reverse-transcription real-time polymerase chain reaction (RT-PCR), is the first test of its type to receive FDA clearance.

Enteroviruses cause 85-95 percent of viral meningitis cases, which typically self-resolve in a week to ten days unlike bacterial meningitis, which is potentially fatal. As patients present, the need to provide a tool to aid in the differentiation between the two entities is critical. Current EV testing methods are slow, delivering results in 3-7 days. Cepheid's Xpert EV test in conjunction with standard CSF tests like bacterial Gram stain, bacterial culture, CSF glucose, CSF-blood glucose ratio, CSF protein concentration, and CSF leukocyte count, fills a clinical testing void by making enteroviral results available to physicians in less than 2.5 hours-- 24 hours a day, 365 days a year. With rapid EV results, physicians may be able to make improved patient treatment decisions.

"With Xpert EV, physicians can identify a patient with or without enteroviral meningitis in hours, thereby helping to more quickly begin appropriate treatment," said Harley A. Rotbart, MD, Professor and Vice Chairman of Pediatrics, University of Colorado at Denver and Health Sciences Center's School of Medicine, Denver.

"The Xpert EV test is fast and easy-to-use, enabling community healthcare facilities -- the institutions that see the most EV cases -- to perform rapid, molecular tests around the clock, a service similar to the services offered only by the largest of medical centers," stated Beverly Rogers, M.D., Chief of Pathology at Children's Medical Center Dallas and Professor of Pathology at The University of Texas Southwestern Medical Center at Dallas.

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