NEW YORK (GenomeWeb) – Becton Dickinson announced today that it has received approval from the US Food and Drug Administration for its BD Max Vaginal Panel for the diagnosis of vaginitis and vaginosis in women who exhibit symptoms of vaginal infections.
The assay runs on the BD Max System, which combines automated real-time PCR extraction, amplification, and detection on a single platform. It is designed to detect the pathogens responsible for bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis.
The FDA's market authorization was granted under a de novo submission, a regulatory pathway used for novel devices of a type not previously classified. It comes less than two months after the FDA approved the BD Max CT/GC/TV Panel, an assay for the sexually transmitted infections Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.
"With the FDA market authorization of the BD Max Vaginal and CT/GC/TV Panels, BD is now able to offer clinical laboratories automated PCR tests to aid in the detection and diagnosis of important reproductive and sexually transmitted infections," Doug White, vice president and general manager of molecular diagnostics and women's health at BD, said in a statement.