BD Expands Reproductive and Sexually Transmitted Infections Portfolio with CE Mark for the BD MAX™ Vaginal Panel

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May 13, 2016, 06:59 ET

FRANKLIN LAKES, N.J., May 13, 2016 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it obtained CE mark for the BD MAX™ Vaginal Panel. The new in vitro diagnostic (IVD) assay will provide laboratories and clinicians the ability to use a single test to detect microorganisms responsible for Bacterial Vaginosis (BV), Candidiasis (CA) and Trichomoniasis (TV), which are the most common infectious causes of vaginitis¹.

Vaginal infections are one of the most common infections affecting women's health, with up to 75 percent of women experiencing at least one case of Vaginitis (CA, TV) or Vaginosis (BV) in their lifetime^1,2. Both co-infections (up to 20 percent) and recurring infections are common^3,4, resulting in a large disease burden. Pervasive inaccurate and inconsistent diagnosis of these conditions, due in part to variations in clinical practice, leaves up to 30 percent of the women seeking treatment undiagnosed. This can lead to continued symptoms, repeat visits, inappropriate or missed treatment and unnecessary associated healthcare system costs¹. In addition to irritating symptoms that disrupt quality of life, these infections have serious risks, including pre-term or low birth-weight babies, late term miscarriage and increased risk of STI transmission or acquisition (including HIV) and Pelvic Inflammatory Disease (PID)^1,2,4,5,6.

"The BD MAX Vaginal Panel provides an objective and accurate solution to this incredibly common health issue. This is an important advancement because using 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," said Dr. Patrick Murray, worldwide senior director of scientific affairs for BD Life Sciences – Diagnostic Systems. "The BD MAX Vaginal Panel has the potential to help clinicians improve patient management and help laboratories increase workflow efficiency."

The BD MAX™ System offers an efficient path to improved outcomes by combining and automating real-time PCR extraction, amplification and detection into a single platform capable of running both FDA-cleared and open-system assays. For more information on BD Molecular Diagnostics, please visit: http://moleculardiagnostics.bd.com/

About BD
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and healthcare worker safety and the technologies that enable medical research and clinical laboratories. The company provides innovative solutions that help advance cellular studies and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes. The company partners with organizations around the world to address some of the most challenging global health issues. BD has more than 45,000 associates across 50 countries who work in close collaboration with customers and partners to help enhance outcomes, lower healthcare delivery costs, increase efficiencies, improve healthcare safety and expand access to health. For more information on BD, please visit www.bd.com.

Hainer BL, Gibson MV. Vaginitis: diagnosis and treatment. A Fam Phys. 2011; 83: 807‐815.
Sherrard J, Donders G, White D. 2. Editor: Jensen JS. 2011 European (IUSTI/WHO) Guideline on the Management of Vaginal Discharge.
Sobel JD. Vulvovaginal candidosis. Lancet 2007;369: 1961–1971.
Powell AM, Nyirjesy P. Recurrent vulvovaginitis. Best Pract Res Clin Obstet and Gynaecol 2014; 28: 967‐976.
Lamont RF, Sobel JD, Akins RA, Hassan SS, Chaiworapongsa T, Kusanovic JP, Romero R. The vaginal microbiome: New information about genital tract flora using molecular based techniques. BJOG 2011;118: 533–549.
Powell K. Vaginal thrush: quality of life and treatments. Br J Nurs 2010; 19: 1106‐1111.