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FDA Clears BD Chlamydia, Gonorrhea Assays

NEW YORK (GenomeWeb) – BD Diagnostics said today the US Food and Drug Administration has cleared for marketing the BD ProbeTec Chlamydia trachomatis Qx Amplified DNA Assay and the BD ProbeTec Neisseria gonorrhea Qx Amplified DNA Assay on the BD Viper LT system.

The BD ProbeTec Qx Assays use BD proprietary ferric oxide, FOX extraction, and strand displacement amplification technologies to directly and qualitatively detect Chlamydia trachomatis and Neisseria gonorrhea DNA. The tests are performed on physician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens, male and female urine specimens, and gynecological specimens collected in BD SurePath Preservative Fluid or PreservCyt Solution.

The assays are indicated for use with asymptomatic and symptomatic individuals to aid in diagnosing chlamydia and gonococcal urogenital disease, BD said.

The molecular BD Viper LT system automates sample liquid handling, nucleic acid extraction, amplification, detection, and result reporting without user intervention. It is designed to provide low-and mid-volume laboratories with reliable detection of chlamydia and gonorrhea from all genital sample types.