BD Gets FDA OK for STD Assays

Hits:1294   Date: 12/8/2009

NEW YORK (GenomeWeb News) – Becton Dickinson today said that the US Food and Drug Administration has cleared for marketing its BD ProbeTec Chlamydia trachomatis Qx and BD ProbeTec Neisseria gonorrhoeae Qx Amplified DNA Assays with samples collected during women's routine liquid-based Pap testing for cervical cancer screening.

The firm said that the assays are the first to gain FDA clearance for gynecological specimens collected and transported in the two leading types of liquid-based cytology (LBC) preservative media on the market today, including its BD SurePath Liquid-based Pap Test. The LBC specimen is then run on the BD Viper System with XTR Technology, a molecular diagnostics system.

"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," Wayne Brinster, VP and GM of women's health and cancer for BD Diagnostics, said in a statement.