Meningitis
Cepheid's Xpert EV Test for Enteroviral Meningitis, Run on the GeneXpert Platform, Receives FDA Clearance
Published in TB and Outbreaks Week, April 3rd, 2007
Cepheid (NASDAQ:CPHD), a broad-based molecular diagnostics company, announced it received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(TM) EV test, which runs on the GeneXpert(R) 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,...
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