BDX - BD wins FDA nod for infectious vaginitis test for use in high throughput platform

2023-03-16 07:27:53 ET

• BD ( NYSE: BDX ) announced Thursday that the FDA issued 510(k) clearance for its BD Vaginal Panel to detect some cases of infectious vaginitis on its BD COR System, a high-throughput analytical system used in large laboratories.
• BD Vaginal Panel is a polymerase chain reaction (PCR) assay that can simultaneously detect microorganisms linked to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV).
• BV, VVC, and TV are the three most common infectious causes of vaginitis.
• The FDA first cleared BD Vaginal Panel in 2016 for the company’s BD MAX™ System, which can provide diagnostic results for up to 24 samples in less than three hours.
• In addition to BD Vaginal Panel, BD COR System offers assays to detect human papillomavirus (HPV) and non-viral causes of sexually transmitted infections (STIs) — Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and Trichomonas vaginalis (TV).
• Read: In December, Seeking Alpha contributor Ian Bezek selected BD ( BDX ) as a quality defensive pick for 2023.

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