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February 1, 2012

Roche’s Cobas Test for Chlamydia and Gonorrhea Granted 510(k) Clearance in U.S.

  • FDA granted 510(k) clearance for Roche’s cobas® CT/NG Test for detecting Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections in both symptomatic and asymptomatic patients using male urine samples and self-collected vaginal swabs. The test was granted a CE mark in 2009.  

    The cobas CT/NG Test is a PCR-based multiplex dual probe assay run on Roche’s automated cobas 4800 system, and will complement the firm’s FDA approved cobas HPV test. 510(k) approval for the CT/NG assay was based on clinical trial data demonstrating that the male urine and female swab samples provide for increased sensitivity and specificity compared with alternative specimen types, across patient populations with both low and high disease prevalences.

    Roche points out that a summary report from the U.S. Association of Public Health Laboratories and Centers for Disease Control and Prevention concluded male urine and self-collected vaginal swabs are the preferred specimen types for CT and NG testing, as they show high sensitivity and are less invasive and less painful to collect than urethral or endocervical samples that can impact screening compliance. The firm is separately developing additional microbiology and oncology tests for the cobas 4800 system. 

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