BD Announces FDA 510(k) Clearance of BD ProbeTec™ Qx Amplified Assays for the Detection of Chlamydia trachomatis and Neisseria gonorrhoeae

Baltimore, MD -- Monday.- BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced today it has received 510(k) clearance from the U.S. Food and Drug Administration for the BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay and the BD ProbeTec™ Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay on the next-generation BD Viper™ System with XTR™ Technology.

The 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 gonorrhea.If left untreated, these infections in women can lead to pelvic inflammatory disease, infertility, ectopic pregnancy and chronic pelvic pain.[1]

“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 Diagnostics - Diagnostic Systems, Molecular Diagnostics. “Running these advanced molecular assays on the BD Viper System with 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 gonorrhea are diagnosed each year.[2] Chlamydia is the most frequently reported bacterial sexually transmitted infection in the United States. Nearly 2.3 million people in the United States between the ages of 14 to 39 are infected with Chlamydia based on the U.S. National Health and Nutrition Examination Survey.[3] The Centers for Disease Control and Prevention estimate that more than 700,000 persons get new gonorrheal infections each year in the United States.[4] From 1975 to 1997, the national gonorrhea rate declined due to the implementation of the national gonorrhea control program in the mid-1970s. After several years of stable gonorrhea rates, however, the national gonorrhea rate has since been on the rise.[4]

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 gonorrhea 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 asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial and gonococcal urogenital disease.[5]

[1] U.S. Preventive Services Task Force. (2001). Screening for chlamydial infection: recommendations and rationale. American Journal of Preventive Medicine 20(Suppl. 3), 90-94.

[2] World Health Organization. (2001). Global prevalence and incidence of selected curable sexually transmitted infections overview and estimates. Retrieved January 5, 2009 from http://www.who.int/hiv/pub/sti/who_hiv_aids_2001.02.pdf

[3] Datta, S.D., Sternberg, M., Johnson, R.E., Berman, S., Papp, J.R., McQuillan, G., et al. (2007). Gonorrhea and Chlamydia in the United States among persons 14 to 39 years of age, 1999 to 2002. Annals of Internal Medicine, 147(2), 89-96.

[4] Centers for Disease Control and Prevention. (2008). Gonorrhea – CDC fact sheet. Retrieved March 12, 2009 from http://www.cdc.gov/std/gonorrhea/stdfact-gonorrhea.htm

[5] Indications for asymptomatic males for GC have not been established.