BD gets FDA authorisation for BD MAX Vaginal Panel
Medical technology company Becton, Dickinson and Company (BD) has secured the US Food and Drug Administration (FDA) authorisation for its BD MAX Vaginal Panel for vaginitis.
Medical technology company Becton, Dickinson and Company (BD) has secured the US Food and Drug Administration (FDA) authorisation for its BD MAX Vaginal Panel for vaginitis.
The BD MAX Vaginal Panel, an in vitro diagnostic (IVD) assay, is a multiplex, real-time polymerase chain reaction (PCR) assay indicated to be used for the diagnosis of both vaginitis and vaginosis in women exhibiting symptoms of vaginal infections.
The vaginal panel features an algorithm which determines the ratio of healthy and unhealthy bacteria thereby resulting in an improved bacterial vaginosis (BV) diagnosis.
"A multiplex microbiome-based real-time PCR assay has the potential to help clinicians improve patient management and help laboratories increase workflow efficiency."
Jersey Shore University Medical Center department of obstetrics and gynecology chair Dr Mark Martens said: "Vaginitis is highly prevalent, with large gaps in clinical management that improved diagnostics could help address.
“Traditional methods used to detect vaginitis can be challenging due to the presence of many interfering substances in specimens, the large number of mixed infections, and the subjectivity of these methods.
“A multiplex microbiome-based real-time PCR assay has the potential to help clinicians improve patient management and help laboratories increase workflow efficiency.”
BD has also secured the FDA approval for its BD MAX CT/GC/TV assay which can detect Chlamydia, Gonorrhea and Trichomoniasis from a single specimen with one test.