FDA Broadens Clearance of Roche’s STD Diagnostic Test
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.