Cepheid Receives FDA Clearance for Xpert® Xpress GBS

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Mar 11, 2024, 07:00 ET

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.

1	ACOG Guidelines: Prevention of Group B Streptococcal Early-Onset Disease in Newborns. https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2020/02/prevention-of-group-b-streptococcal-early-onset-disease-in-newborns
2	With early assay termination for positives only; reporting of negatives in approximately 42 minutes
3	Blaser MJ et al., Infant antibiotic exposures and early-life body mass, Int J Obes (Lond). 2013 January ; 37(1): 16–23

US-IVD. In Vitro Diagnostic Medical Device.

About Cepheid
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.

For Cepheid Media Inquiries:
Darwa Peterson
[email protected]

SOURCE Cepheid