BD MAX™ Vaginal Panel Receives FDA Market AuthorizationReceives FDA Market Authorization to Detect Most Common Causes of Vaginal Infections
BD MAX™ Vaginal Panel Receives FDA Market Authorization to Detect Most Common Causes of Vaginal Infections
Expands Reproductive and Sexually Transmitted Infections Portfolio with First Test Using Microbiome-based Algorithm for Bacterial Vaginosis Detection
Franklin lakes, N.J., Oct. 31, 2016 – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) market authorization for a first-of-its-kind molecular test to detect the most common causes for vaginitis.
Laboratories and clinicians will now have the ability to use a single test to detect microorganisms responsible for Bacterial Vaginosis (BV), Trichomoniasis (TV) and Vulvovaginal Candidiasis (VVC), also known as a yeast infection, which are the most common infectious causes of vaginitis.1,2,3 The new in vitro diagnostic (IVD) assay is the first multiplex, real-time polymerase chain reaction (PCR) assay authorized by