Research & Development
Roche wins US FDA clearance for cobas CT/NG, 6800/8800 Systems for molecular testing of sexually transmitted infections
16 April 2018 -

Pharmaceutical 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 assay, cobas 6800/8800 Systems for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in both symptomatic and asymptomatic individuals.

Chlamydia trachomatis is the most common bacterial Sexually Transmitted Disease (STD) among youth. Neisseria gonorrhoeae is the second most commonly reported bacterial STD in the US. Gonococcal infections in women are often asymptomatic and may not be immediately recognized, which can progress to pelvic inflammatory disease, tubal scarring, infertility and ectopic pregnancy.

The company said the cobas CT/NG is the first assay available in the US for the testing of sexually transmitted infections on the cobas 6800/8800 Systems. It is cleared for use with male and female urine specimens, clinician-instructed self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, endocervical swab specimens (all collected in cobas PCR media) and cervical specimens collected in PreservCyt Solution.

In conjunction, other STI assays are in development that will allow laboratories to consolidate high volume STI testing on a single platform, added the company.

Based on Nobel prize-winning PCR technology, the the fully automated cobas 6800/8800 systems deliver proven performance with full automation, increased throughput, fast turnaround time, complete track connectivity as well as providing users with greater flexibility to consolidate their testing to a single system, while increasing overall workflow efficiencies.

Additionally, the cobas 6800/8800 systems provide up to 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, concluded the company.



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