DURHAM, N.C., Dec. 7 /PRNewswire-FirstCall/ -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company) , 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.
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.
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.
For more information on the BD Viper System with XTR Technology and the BD ProbeTec Qx Amplified DNA Assays, please visit: http://www.bd.com/ds/productCenter/MD-Viper.asp. To learn more about the BD SurePath Liquid-based Pap Test, please visit: http://www.bd.com/tripath/products/surepath/index.asp.
About BD
BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 29,000 associates in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.
(i) The FDA also cleared the BD ProbeTec Qx Amplified DNA Assays to be tested with LBC specimens collected with Hologic ThinPrep(R) PreservCyt(R) Solution.
(ii) U.S. Preventive Services Task Force. (2001). Screening for Chlamydial infection: recommendations and rationale. American Journal of Preventive Medicine 20 (Suppl. 3), 90-94.
(iii) Silins I, Ryd W, Strand A, et al. Chlamydia trachomatis infection and persistence of human papillomavirus. Int J Cancer. 2005;116(1):110-115.
(iv) U.S. Centers for Disease Control and Prevention. Sexually transmitted disease surveillance, (2007). Atlanta, GA: US Department of Health and Human Services, CDC; 2008. Available at http://www.cdc.gov/std/stats07/toc.htm.
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