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Cepheid Nabs FDA Clearance for Molecular Group B Strep Test

NEW YORK – Danaher subsidiary Cepheid announced Monday that it has received clearance from the US Food and Drug Administration for its Xpert Xpress GBS test for group B Streptococcus

The dual-target test is intended for the qualitative intrapartum detection of group B strep (GBS), incorporating targets in highly conserved regions of the GBS genome to improve sensitivity and bacterial strain coverage, Cepheid said in a statement. 

The assay is designed for use on Cepheid's GeneXpert PCR systems and can return positive results in 30 minutes. It will begin shipping to US customers this month, Cepheid said. 

"Up to 50 percent of colonized mothers may pass a group B Streptococcus infection to their newborn baby, leading to an increased risk of early-onset neonatal sepsis," David Persing, Cepheid's chief medical and scientific officer, said in a statement. "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."