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FDA Clears Roche's Chlamydia/Gonorrhea Assay

NEW YORK (GenomeWeb News) – Roche today announced 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 PCR-based multiplex dual probe assay runs on the cobas 4800 platform and is complementary to the cobas HPV Test, which was cleared by FDA last year. The test is for detecting CT and NG infections in symptomatic and asymptomatic patients using urine in men and self-collected vaginal swabs.

It received CE marking in 2009.

Citing a report from the US Association of Public Health Laboratories and Centers for Disease Control and Prevention, Roche said that male urine and self-collected vaginal swabs are the preferred specimen types for CT and NG testing. The specimen types are considered a progressive option for CT/NG screening because of high sensitivity. Additionally, they provide less invasive and less painful options to urethral or endocervical samples and may promote screening compliance, Roche said.

A trial for the test confirmed that self-collect vaginal specimens and male urine specimens show increased sensitivity and specificity compared with other specimen types in populations with low- and high-disease prevalence, the company added.

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