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BD Obtains CE Mark for CT/GC/TV and CT/GC Assays on the BD MAX™ System


BD obtains CE Mark for the BD MAX™ CT/GC/TV and CT/GC assays, part of the BD Reproductive and Sexually Transmitted Infections portfolio


BD
Matthew Coppola
Public Relations
(201) 847-7370
Email: Matthew_R_Coppola@bd.com

Baltimore, MD () – 

BD Life Sciences, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it obtained CE Mark for the BD MAX™ CT/GC/TV and CT/GC assays, new additions to the BD Reproductive and Sexually Transmitted Infections Portfolio. The BD MAX™ CT/GC/TV and CT/GC assays will provide customers the ability to detect for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and Trichomonas vaginalis (TV) from a single specimen in just one run.

CT, GC and TV are among the most prevalent sexually transmitted infections (STIs). The World Health Organization estimates that globally 105.7 million new cases of infection due to Chlamydia trachomatis, 106.1 million new cases of infection due to Neisseria gonorrhoeae and 27.4 million new cases of Trichomonas vaginalis occur each year.1 These infections can have serious consequences if left unaddressed, such as pelvic inflammatory disease, ectopic pregnancy, infertility, pre-term or low birth-weight babies and increased risk of STI transmission or infection (including HIV) in males and females.

The BD MAX™ CT/GC/TV and CT/GC assays represent yet another molecular diagnostics innovation for BD Life Sciences – Diagnostic Systems. With these assays, customers will be able to detect these common and addressable STIs in a single specimen and run. Collection options are flexible, allowing for male or female urines, self-collected vaginal swabs and clinician collected endocervical swabs. Once samples are loaded onto the BD MAX™ System, results will be ready in less than three hours, and all reagents are ready-to-use, room temperature storage.

"We're pleased to be able to offer customers the convenience and performance of our BD MAX™ CT/GC/TV and CT/GC assays along with the capabilities of our easy-to-use, fully automated BD MAX™ platform,” said Doug White, Vice President and General Manager, Molecular Diagnostics and Women’s Health, BD Life Sciences – Diagnostic Systems. “We are dedicated to expanding the BD MAX™ portfolio with clinically relevant assays that help enable our customers to improve clinical outcomes while providing enhanced workflow and efficiency in the clinical laboratory.”

The BD MAX™ System offers an efficient path to improved clinical outcomes by combining and automating real-time PCR extraction, amplification and detection and into a single platform capable of running both FDA-cleared and open-system assays. Such flexibility and standardization allow you to address a wide breadth of testing needs. The BD MAX™ System is part of a BD Life Sciences – Diagnostic Systems portfolio of molecular solutions. For more information on BD Molecular Diagnostics, please contact us.

 

About BD
BD is a leading medical technology company that partners with customers and stakeholders to address many of the world’s most pressing and evolving health needs. Our innovative solutions are focused on improving medication management and patient safety; supporting infection prevention practices; equipping surgical and interventional procedures; improving drug delivery; aiding anesthesiology and respiratory care; advancing cellular research and applications; enhancing the diagnosis of infectious diseases and cancers; and supporting the management of diabetes. We are more than 45,000 associates in 50 countries who strive to fulfill our purpose of “Helping all people live healthy lives” by advancing the quality, accessibility, safety and affordability of healthcare around the world. In 2015, BD welcomed CareFusion and its products into the BD family of solutions. For more information on BD, please visit www.bd.com.

1. WHO Global Incidence and Prevalence of Selected Curable Sexually Transmitted Infections 2008
2. Package Insert, BD MAX CT/GC and BD MAX CT/GC/TV Assay