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Becton Dickinson Gets CE Mark for Vaginal Pathogen Panel

NEW YORK (GenomeWeb) – Becton Dickinson announced today it has received CE marking for the BD Max Vaginal Panel.

The panel runs on the BD Max System, which combines automated real-time PCR extraction, amplification, and detection on a single platform and can run both US Food and Drug Administration-cleared and open-system assays.

The Vaginal Panel detects the pathogens responsible for bacterial vaginosis, candidiasis, and trichomoniasis, which are the most common infectious causes of a syndrome called vaginitis. The firm noted that up to 75 percent of women will have vaginitis in their lifetimes, with co-infections and recurring infections common. 

"The BD MAX Vaginal Panel has the potential to help clinicians improve patient management and help laboratories increase workflow efficiency," Patrick Murray, worldwide senior director of scientific affairs for BD Life Sciences Diagnostic Systems said in a statement. "Traditional methods to detect the responsible microorganisms can be challenging due to the presence of many interfering substances in specimens, the large number of mixed infections which occur, and the subjectivity of these methods, which can lead to inconsistent interpretation of test results."

The US Centers for Disease Control and Prevention recommended nucleic acid testing for trichomonas last year, specifically mentioning BD's ProbeTec test for that parasite in its guidelines. Nucleic acid testing has also been emphasized in the most recent guidelines from the US Preventative Services Task Force for diagnosis of the sexually transmitted infections chlamydia and gonorrhea.