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Roche Obtains FDA Clearance for Sexually Transmitted Disease Test

NEW YORK (GenomeWeb) – Roche said today that it has received US Food and Drug Administration 510(k) clearance for its Cobas TV/MG test for the detection of Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in symptomatic and asymptomatic patients.

The test, which runs on Roche's Cobas 6800 and Cobas 8800 real-time PCR systems, expands the company's existing test menu and has been validated for use on different specimen types, including male or female urine, endocervical swabs, and vaginal swabs collected by clinicians or patients in a clinical setting. Labs can now assess a patient sample for TV/MG as well as using the existing Cobas CT/NG test for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).

"The launch of the Cobas TV/MG continues our expansion of our STI menu, giving healthcare providers and their patients greater access to more information from a single sample," said Mario Torres, head of Roche Molecular Diagnostics, in a statement.

"These new analytes, in conjunction with the approved Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) molecular diagnostic assays, will support a more thorough assessment of the potential pathogens responsible for discharge-causing STI," said Barbara Van Der Pol, associated professor of medicine at the University of Alabama at Birmingham School of Medicine, in a statement. "As a result, clinicians can more easily identify co-infections and utilize appropriate treatment strategies earlier in the patient management process."