Roche said this week that its Cobas CT/NG test for Chlamydia trachomatis and Neisseria gonorrhoeae infections has received 510(k) clearance from the US Food and Drug Administration.

The multiplex PCR-based dual-probe assay runs on the Cobas 4800 platform and complements the Cobas HPV Test, which FDA cleared last year. Cobas CT/NG is designed to detect CT and NG infections in symptomatic and asymptomatic patients using urine in men and self-collected vaginal swabs in women. The test received the CE IVD mark in 2009.

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