FDA Clears Cepheid's GBS Test as IVD, Lifting Shares 8 Percent

Jul 26, 2006

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing Cepheid's Xpert clinical molecular diagnostic for Group B Streptococcus, the company said today.

The test runs on the GeneXpert Dx system and is an in vitro diagnostic designed to detect Group B Strep DNA in vaginal and rectal swabs. It is the first test “in a planned menu of Xpert tests” based on the GeneXpert platform, said Cepheid CEO John Bishop.

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