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Medical Devices / Submissions and Approvals

FDA Broadens Clearance of Roche’s STD Diagnostic Test

May 24, 2019
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Roche has nabbed 510(k) clearance for its Cobas TV/MG test, enabling its Cobas 6800/8800 Systems to detect Trichomonas vaginalis (TV) and mycoplasma genitalium. (MG)

Using a single sample from a symptomatic or asymptomatic patient, laboratories can now simultaneously screen for four different STDs using the Cobas test: chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), TV and MG.

The Cobas TV/MG test can use various sample types to detect the two STDs, including urine samples, vaginal swabs and endocervical swabs.

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