Diagnostic company Roche (SIX:RO) (ROG:RHHBY) (OTCQX:RHHBY) reported on Thursday the receipt of US Food and Drug Administration (FDA) 510(k) clearance for the cobas TV/MG test for use on the cobas 6800/8800 Systems for the detection of Trichomonas vaginalis (TV) and/or Mycoplasma genitalium (MG) DNA.

TV is reportedly the most common non-viral sexually transmitted infection (STI) in the world. MG is a fastidious bacterium and infections are often asymptomatic.

According to Roche, laboratories can now simultaneously process from a single patient sample a combination of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), TV and MG, which provides clinicians the information they need to screen and diagnose STIs and improve patient care, in both symptomatic and asymptomatic patients.

The addition of the cobas TV/MG test continues the expansion of the testing menu on the cobas 6800/8800 Systems. The test has been validated for use with broad sample types comparable to those available for use with the cobas CT/NG test: male/female urine, endocervical swabs and vaginal swabs.

Since 2014, the cobas 6800 and cobas 8800 Systems have established the new standard for routine molecular testing by delivering fully integrated, automated solutions that serve viral load monitoring, donor screening, sexual health and microbiology. Based on Nobel prize-winning PCR technology, the systems provide up to 96 results in about three hours and a total of 864 results for the cobas 6800 System and 1,824 results for the cobas 8800 System from an eight-hour shift, Roche said.