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

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.

The Scan

More Boosters for US

Following US Food and Drug Administration authorization, the Centers for Disease Control and Prevention has endorsed booster doses of the Moderna and Johnson & Johnson SARS-CoV-2 vaccines, the Washington Post writes.

From a Pig

A genetically modified pig kidney was transplanted into a human without triggering an immune response, Reuters reports.

For Privacy's Sake

Wired reports that more US states are passing genetic privacy laws.

Science Paper on How Poaching Drove Evolution in African Elephants

In Science this week: poaching has led to the rapid evolution of tuskless African elephants.