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.
The 510(k) clearance paves the way for Cepheid to market the test in the United States.
Shares in Cepheid rose 8 percent, or $.67, to $8.87 in mid-afternoon trading on the news.