FDA approves BD MAX Vaginal Panel diagnostic for vaginitis- BD

BD has announced U.S. FDA market authorization for BD MAX Vaginal Panel, a first-of-its-kind molecular test to detect the most common causes for vaginitis. The new in vitro diagnostic (IVD) assay is the first multiplex, real-time polymerase chain reaction (PCR) assay authorized by FDA for the diagnosis of both vaginitis and vaginosis in women that exhibit symptoms of vaginal infections.

BV diagnosis is challenging, as it is caused by bacterial imbalances in the vagina. To address this challenge, the BD MAX Vaginal Panel has a unique algorithm that determines the ratio of healthy versus unhealthy bacteria, improving BV diagnosis. FDA market authorization was granted under a de novo petition, which is a regulatory pathway for novel products that are first-of-a-kind.