Cepheid receives expanded FDA clearance with CLIA waiver for Xpert Xpress MVP

Cepheid announced 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). The test runs on Cepheid's GeneXpert Xpress instruments and has been approved for testing women fourteen years of age and older.

Cepheid release