Cepheid receives FDA clearance for GBS test

Cepheid has received clearance from the US Food and Drug Administration for Xpert Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of group B Streptococcus (GBS). This next-generation test incorporates new dual targets in highly-conserved regions of the GBS genome to improve sensitivity and bacterial strain coverage.

Group B Streptococcus (GBS) is the leading cause of newborn infection. The American College of Obstetrics and Gynecology (ACOG) guidelines recommend antepartum (before labour) screening for GBS and intrapartum (during labour) antibiotic prophylaxis for GBS-colonised women, to help decrease early-onset sepsis in newborns due to GBS infection.

However, in some places testing rates remain relatively low, leading to unnecessary antibiotics being given to GBS-negative females. Xpert Xpress GBS allows for the use of intrapartum direct PCR testing for women with unknown or unavailable antepartum GBS status. The test is designed for use on Cepheid's GeneXpert systems.

With the capability of returning positive results as early as 30 minutes, Xpert Xpress GBS can provide real-time GBS status and inform decisions about empiric antibiotic prophylaxis if appropriate, to prevent GBS transmission during birth.

"Up to 50% of colonised mothers may pass a group B Streptococcus infection to their newborn baby, leading to an increased risk of early-onset neonatal sepsis," said David Persing MD PhD, EVP, Chief Medical and Scientific Officer. "The newly updated Xpert Xpress GBS test enhances gene coverage and provides a rapid and accessible laboratory-quality result when it is needed most, to help prevent mother-to-child transmission while also advancing antimicrobial stewardship."


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