Cepheid Receives CE Mark for Xpert® Xpress GBS

14 November 2022

SUNNYVALE, Calif. /PRNewswire/ -- Cepheid announced today that it has received the CE mark for Xpert® Xpress GBS, a molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus (GBS). Xpert Xpress GBS test is expected to begin shipping to European customers this month.

This next-generation test improves the current IVD test, Xpert GBS, by enhancing gene coverage and incorporating new dual targets in highly-conserved regions of the GBS genome.

Many local guidelines recommend universal antepartum screening for GBS to help decrease early-onset neonatal sepsis – however, testing remains relatively low in some places leading to unnecessary antibiotics being given to GBS-negative females. With positive results as early as 30 minutes,1 Xpert Xpress GBS enables testing at the time of delivery, which provides real-time GBS status as compared to antepartum culture results earlier in pregnancy. With Xpert Xpress GBS, Cepheid continues to provide fast, accurate, and reliable PCR solutions to facilitate evidence-based treatment and improved clinical care.

Xpert Xpress GBS is cleared to be used for screening of pregnant females, in line with the European consensus for intrapartum GBS testing.2 The test is designed for use on Cepheid's GeneXpert® systems throughout Europe.

"Up to 50% of colonized mothers may pass a Group B Streptococcus infection to their newborn baby, leading to an increased risk of early-onset neonatal sepsis,3" said David Persing, M.D., Ph.D., EVP, and Chief Scientific Officer. "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."

Visit https://www.cepheid.com/en for more information.

CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries.

  1. With early assay termination for positives only; reporting of negatives in approximately 42 minutes
  2. Di Renzo et al. Intrapartum GBS screening and antibiotic prophylaxis: a European consensus conference. J Maternal Fetal Neonatal Med. 2014:1-17. https://pubmed.ncbi.nlm.nih.gov/25162923
  3. Blaser MJ et al., Infant antibiotic exposures and early-life body mass, Int J Obes (Lond). 2013 January ; 37(1): 16–23

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