BD’s COR System Cleared for Detecting Three Causes of Vaginitis

The FDA has granted 510(k) clearance to BD’s vaginal panel on the company’s high-throughput molecular diagnostic platform for large laboratories, which tests for the three most common infectious causes of vaginitis with one swab.

The panel is a microbiome-based polymerase chain reaction assay to test for bacterial vaginosis, vulvovaginal candidiasis and Trichomonas vaginalis. The results for each condition are displayed as either positive or negative.

Four out of 10 women don’t receive the appropriate diagnosis and treatment for their vaginitis symptoms after an initial physician visit, which leads to additional visits because of persistent symptoms, the company said.