BD Announces CE Marking of BD ProbeTec™ Qx Amplified Assays to Improve Detection of Chlamydia trachomatis and Neisseria gonorrhoeae

Baltimore, MD .- BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced today the CE marking of the BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay and the BD ProbeTec™ Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay for use on the BD Viper™ System with XTR™ Technology.

This next-generation BD Viper System with XTR technology enables laboratories to process a higher volume of tests automatically from swabs or urine samples, with significantly less labor and more reliable test results. This improvement in process efficiency may lead to a higher number of accurate diagnoses and more appropriate patient care for the two most common sexually transmitted infections – Chlamydia and gonorrhoeae. If left untreated, these infections in women can lead to pelvic inflammatory disease, infertility, ectopic pregnancy and chronic pelvic pain.

“BD ProbeTec Qx Amplified DNA Assays are designed to meet the needs of today’s high-volume clinical laboratories, providing extremely reliable detection of Chlamydia trachomatis and Neisseria gonorrhoeae,” said Gregory Meehan, Vice President of BD Diagnostic Systems, Molecular Diagnostics. “Running these advanced molecular assays on the BD Viper System with advanced XTR technology offers laboratories total system integrity that helps assure reliability in their systems, reagents and results.”

The fully automated system processes up to 736 patient samples in a single work shift. It offers the least hands-on time for setup, sample extraction, workflow and maintenance. One operator can fully execute all of the functions required to report results with several BD Viper Systems operating concurrently.

The World Health Organization estimates that 92 million new cases of Chlamydia and 62 million new cases of gonorrhoeae are diagnosed each year.1 Genital Chlamydia is the most commonly diagnosed sexually transmitted infection in genitourinary medicine clinics in the United Kingdom. In 2006, there were more than 113,500 cases of uncomplicated infection, a rise of four percent from 2005.2 The detection of Chlamydia infections has risen steadily in men and women since the mid-1990s, due mainly to increased testing and improved diagnostic tests. Rates of gonococcal infections have declined in both men and women since 2003, with an overall drop of one percent (19,248 to 19,007) in 2006.3

About BD ProbeTec Qx Assays and the BD Viper System with XTR Technology

The new BD Viper System with XTR Technology is designed to provide high-volume customers with highly reliable detection of Chlamydia and gonorrhoeae at a high throughput rate using an internal extraction control and process verification. When tested with the BD Viper System with XTR Technology, the BD ProbeTec CT Qx and GC Qx Amplified DNA 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), and male and female urine specimens. These assays are indicated for use with asymptomatic4 and symptomatic individuals to aid in the diagnosis of chlamydial and gonococcal urogenital disease.