Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP
Cepheid has received U.S. Food and Drug Administration (FDA) Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert Xpress MVP. This multiplex vaginal panel can now be performed in near-patient settings, enabling results within 60 minutes from a single specimen for Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV). This expanded claim further exemplifies Cepheid’s commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care and can now be run on Cepheid's GeneXpert Xpress instruments.
Each year, about 10 million healthcare visits by women in the U.S. are related to vaginitis symptoms. Diagnosis of vaginitis is often made through a clinical examination where the physician will prescribe a treatment regimen that may not be targeted to the patient’s specific infection type. Sequential treatment failures prolong patient suffering and increase the potential for antimicrobial resistance. Since the causative agents are from three distinct pathogen classes, but present with similar symptoms, a precise diagnosis afforded by multiplexed PCR testing can enable more targeted and timely treatments.
CLIA Waived Performance:
References
US-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries.
