BD Diagnostics receives FDA clearance on Amplified DNA Assays

BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), announced today it has received clearance from the U.S. Food and Drug Administration (FDA) to utilize its BD ProbeTec(TM) Chlamydia trachomatis (CT) Qx and BD ProbeTec(TM) Neisseria gonorrhoeae (GC) Qx Amplified DNA Assays with samples collected during women's routine liquid-based Pap testing for cervical cancer screening.

"BD is leveraging technologies and expertise across the Company to enhance disease detection and patient management in women's health," said Wayne Brinster, Vice President and General Manager, Women's Health and Cancer, BD Diagnostics. "Providing physicians and laboratories with the ability to test for chlamydia and gonorrhea while screening for cervical cancer increases their efficiency, and more importantly, improves the level of information they have to make important patient care decisions."

The BD ProbeTec Qx Amplified DNA Assays are the first to receive FDA clearance for gynecological specimens collected and transported in the two leading types of liquid-based cytology (LBC) preservative media on the market today.(i) These include the BD SurePath(TM) Liquid-based Pap Test, which uses detachable-head collection devices that help ensure 100 percent of collected cells are sent to the laboratory for analysis. Only the BD SurePath Pap test has FDA-approved claims for achieving the highest increase in HSIL+ disease detection and significantly reducing unsatisfactory samples.

After collecting the LBC sample, the physicians will send it to a laboratory for testing. If the physician ordered chlamydia and gonorrhea screening, the laboratory professional trained in handling molecular diagnostic specimens will extract enough specimen from the LBC vial to run the BD ProbeTec Qx Amplified DNA Assays on the next-generation BD Viper(TM) System with XTR(TM) Technology. The remaining specimen will then be forwarded to the cytology lab for LBC slide preparation and testing.

The BD Viper System with XTR Technology enables laboratories to process a higher volume of tests automatically from swabs, urine, and now with LBC preservative media. The system requires significantly less hands-on time and provides greater reliability than other systems. This improvement in process efficiency may lead to more timely diagnosis and treatment for the two most common sexually transmitted infections (STIs) chlamydia and gonorrhea.

If left untreated, these infections in women can lead to pelvic inflammatory disease, infertility, ectopic pregnancy and chronic pelvic pain.(ii) Cytological screening of cervical specimens can aid in the prevention of cervical cancer. Co-infections with chlamydia are an epidemiologic factor associated with the risk of cervical cancer.(iii) According to a recent report issued by the U.S. Centers for Disease Control and Prevention, the incidence of chlamydia has never been higher, with more than 1.1 million cases reported in 2007.(iv) It is the most prevalent STI in the United States.


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