Healthcare firm Roche receives FDA clearance for cobas CT/NG

Swiss drug major Roche has recently made it to the headlines for receiving a 510(k) FDA clearance for cobas CT/NG. Reportedly, the drug is being used in the cobas 6800/8800 Systems to directly detect CT (Chlamydia trachomatis) or/and NG (Neisseria gonorrhoeae) DNA in both asymptomatic and symptomatic individuals.

Sources familiar with the matter revealed that cobas CT/NG is the first assay that will be available in the US healthcare industry for testing of sexually transmitted diseases & infections on the cobas 6800/8800 Systems. As per authentic reports, cobas CT/NG is cleared for use in a broad set of urogenital samples comprising specimens of clinician-collected vaginal swabs, urine specimens, cervical specimens collected in PreservCyt® Solution, clinician instructed self-collected vaginal swab specimens, and specimens of endocervical swab.

Uwe Oberlaender, Head of Roche Molecular Diagnostics asserted in a company statement that sexually transmitted infection rates are on a global high and the cobas CT/NG is set to help the laboratories meet increasing testing volumes with highest throughput platform. He further added that cobas CT/NG’s exemplary workflow, exceptional performance, & a flexible testing solution, will undeniably aid the labs free up their staff to carry out other important tasks while still ensuring accuracy and speed in results.

Experts speculate the FDA clearance of cobas CT/NG to considerably strengthen Roche’s foothold in the healthcare industry as its new platform provides a user-friendly solution that significantly minimizes hands-on time and maximizes the flexibility of STI screening. It has also been reported that the healthcare industry has been witnessing the development of several other STI assays that will allow labs to consolidate high volume texting of sexually transmitted infections on a single platform.

For the record, since its launch in 2015, the fully automated cobas 6800/8800 Systems have delivered proven performance with complete automation, fastest turnaround time, highest efficiency & allegedly the longest walk-away time available among the automated molecular platforms.