Pharmaceuticals company Roche (SIX:RO) (OTCQX:RHHBY) reported on Monday the receipt of US Food and Drug Administration (FDA) 510(k) clearance for cobas CT/NG for use on the cobas 6800/8800 Systems for the direct detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae.

The company said the cobas CT/NG is the first assay available in the US for the testing of sexually transmitted infections in both symptomatic and asymptomatic individuals on the cobas 6800/8800 Systems. It is cleared for use with male and female urine specimens, clinician-instructed self-collected vaginal swab specimens, clinician-collected vaginal swab specimens, endocervical swab specimens and cervical specimens collected in PreservCyt Solution.

According to the company, the cobas 6800 and cobas 8800 Systems provide 96 results in about three hours and 864 results for the cobas 6800 System and 1,824 results for the cobas 8800 System from an eight-hour shift. Both make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems enable up to eight hours (cobas 6800 System) and four hours (cobas 8800 System) of walk-away time with minimal user interaction.

Additionally, the cobas 6800/8800 Systems menu includes viral load monitoring tests for HIV, HBV, HCV and CMV, MPX, WNV, DPX and Zika for use in screening blood donations, revealed the company.

Chlamydia trachomatis is the most common bacterial Sexually Transmitted Disease (STD), with the highest prevalence among youth. Neisseria gonorrhoeae is the second most commonly reported bacterial STD in the US.