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Cepheid Nabs CE Mark for Group B Strep Test

NEW YORK – Cepheid said Monday it secured CE-IVD marking for its group B Streptococcus assay, Xpert Xpress GBS, and will start selling the test in Europe this month.

The Sunnyvale, California-based firm, a unit of Danaher, said the assay improves on its existing Xpert GBS test by enhancing gene coverage and adding two new targets in conserved regions of the bacteria's genome. The assay, to be used in pregnant women around childbirth, delivers positive results in as little as 30 minutes, which allows for testing at the time of delivery and real-time diagnosis of infections.

David Persing, Cepheid's CSO, said in a statement that up to half of women colonized with group B Streptococcus infections can pass the bacteria to their children, increasing the risk of early-onset neonatal sepsis.

"The newly updated Xpert Xpress GBS test enhances gene coverage and provides a rapid and accessible lab-quality result when it is needed most, to help prevent mother-to-child transmission while also advancing antimicrobial stewardship," he said.

The test is designed for use on Cepheid's GeneXpert instruments.