Action required: Please refresh your browser
We have recently implemented some changes that require a hard refresh of your browser: Please hold down the CTRL-key and press the F5 key.
After a successful hard refresh, this message should not appear anymore.
More details about this topic are available here »
Cepheid Receives FDA Clearance for Xpert® Xpress GBS | ||||||||
By: PR Newswire Association LLC. - 11 Mar 2024 | Back to overview list |
|||||||
Redesigned test introduces two new targets to improve coverage and sensitivity for Group B Streptococcus intrapartum testing for pregnant females 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. 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 and intrapartum (during labor) antibiotic prophylaxis for GBS-colonized women, to help decrease early-onset sepsis in newborns due to GBS infection.1 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. 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. "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, Chief Medical and 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." 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 will begin shipping to U.S. customers this month. Visit https://www.cepheid.com for more information.
US-IVD. In Vitro Diagnostic Medical Device. About Cepheid For Cepheid Media Inquiries:
View original content to download multimedia:https://www.prnewswire.com/news-releases/cepheid-receives-fda-clearance-for-xpert-xpress-gbs-302084992.html SOURCE Cepheid |
||||||||
|
||||||||
Copyright 2024 PR Newswire Association LLC. | Back to overview list |