Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP

18 Jan 2024
www.prnewswire.com
Drug Approval
Multiplex Vaginal Panel (MVP) delivers faster identification of
three distinct conditions within an hour
SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA Clearance with 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 exemplifies Cepheid's commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care. The test runs on Cepheid's GeneXpert
Xpress instruments and has been approved for testing women fourteen years of age and older.
Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP
Preview
Source: PRNewswire
Cepheid's Xpert® Xpress MVP: Designed to Uncomplicate the Diagnosis of Vaginitis
Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP
Preview
Source: PRNewswire
Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP
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