Cepheid Receives FDA Clearance for Xpert® Xpress GBS
SUNNYVALE, Calif., March 11, 2024 /PRNewswire/ -- Cepheid announced today that it has received clearance from the U.S. 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. The test is designed for use on Cepheid's GeneXpert® systems.
- SUNNYVALE, Calif., March 11, 2024 /PRNewswire/ -- Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration for Xpert® Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus (GBS).
- Xpert Xpress GBS allows for the use of intrapartum direct PCR testing for women with unknown or unavailable antepartum GBS status.
- With the capability of returning positive results as early as 30 minutes,2 Xpert Xpress GBS can provide real-time GBS status and inform decisions about empiric antibiotic prophylaxis if appropriate, to prevent GBS transmission during birth.
- With Xpert Xpress GBS, Cepheid continues to provide fast, accurate, and reliable PCR solutions to facilitate evidence-based treatment and improved clinical care.