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FDA Approves Cepheid's Meningitis PCR-Based Dx Test; Shares Spike 7 Percent

NEW YORK (GenomeWeb News) –  The US Food and Drug Administration has cleared a Cepheid test designed to help physicians detect viral meningitis within two-and-a-half hours, the FDA said today.
News of the clearance caused shares in Cepheid to trade up 7 percent today at $9.22 in the mid-afternoon.
Cepheid’s Xpert EV test is an automated diagnostic that uses reverse transcription PCR on cerebrospinal fluid samples to determine if a patient has enterovirus, which causes 90 percent of meningitis cases, the FDA said. The test is run on the company’s GeneXpert diagnostic system.
The FDA said that in a multi-site study the test was 96-percent accurate in detecting viral meningitis, and 97-percent accurate in patients who did not have the enterovirus.
Bacterial meningitis is far more lethal than the viral form of the disease, and requires swift diagnosis. Because symptoms of the two diseases are so similar, doctors currently treat viral patients empirically with antibiotics for the bacterial form.
Being able to swiftly determine which pathogen a patient has should allow doctors to make more accurate therapeutic decisions and avoid unnecessary antibiotic treatments, the FDA said.

The Scan

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