March 13, 2024- Cepheid announced 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.
Group B Streptococcus (GBS) is the leading cause of newborn infection. The American College of Obstetrics and Gynecology (ACOG) guidelines recommend antepartum (before labor) screening for GBS.