New Chlamydia and Gonorrhea Assays on the BD Viper LT System Receive CE/IVD Marking

Assays bring an innovative solution to microbiology and molecular labs

Jul 28, 2014

BALTIMORE, MD, July 28, 2014 – BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced today that it has achieved CE/IVD marking for the BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay on the BD Viper LT System.

The BD Viper LT System is a bench-top molecular platform that automates sample liquid handling, nucleic acid extraction, amplification, detection and result reporting without any user intervention. The BD Viper LT System is designed to manage primary sample tubes with pierceable caps and ready to use reagents. This “load and go” reagent and sample capability along with the easy to use design of the BD Viper LT System delivers true walkaway time to the laboratorian and maximizes productivity.

The combination of the BD Viper LT System and the BD ProbeTec Chlamydia trachomatis (CT) Qx and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assays brings an innovative solution to microbiology and molecular labs that increases flexibility and improves laboratory efficiency. Improved efficiency provides more timely diagnostic information to clinicians for more effective patient management of two of the most common sexually transmitted bacterial infections - Chlamydia and gonorrhea. If left untreated, these infections can lead to pelvic inflammatory disease, infertility, ectopic pregnancy and chronic pelvic pain.1 The World Health Organization estimates that 105.7 million new cases of Chlamydia and 106.1 million new cases of gonorrhea are diagnosed each year.2

“The BD Viper LT system and the BD ProbeTec Qx Amplified DNA Assays are designed to meet the needs of today's clinical laboratories, providing automated, accurate and reliable detection of Chlamydia trachomatis and Neisseria gonorrhoeae, for all genital sample types," said Doug White, Vice President, General Manager, Molecular Diagnostics & Women’s Health, BD Diagnostics - Diagnostic Systems.

The new BD Viper LT System is designed to provide low and mid-volume laboratories with highly reliable detection3 of Chlamydia and gonorrhea from all genital sample types on an automated and easy to use platform. When tested with the BD Viper LT System, the BD ProbeTec Qx Assays use BD proprietary ferric oxide, FOX Extraction, and Strand Displacement Amplification technologies for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA. The tests are performed on clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), male and female urine specimens (neat and UPT) and gynecological specimens collected in BD SurePath Preservative Fluid or PreservCyt Solution. These assays are indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial and gonococcal urogenital disease.

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to better diagnose disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit bd.com.

For more information on BD, please visit bd.com.

Troy Kirkpatrick

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