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Roche Gets CE-IVD Mark for CT/NG Test on Cobas 6800/8800 Systems

NEW YORK (GenomeWeb) – Roche has received the CE-IVD mark for a test to detect and distinguish Chlamydia trachomatis and Neisseria gonorrhoeae on its Cobas 6800/8800 Systems and has launched the test in countries that accept the CE marking.

The test is notable for being the first to receive claims for anorectal and oropharyngeal samples, the firm said in a statement. Up to half of infections may be missed by traditional urogenital specimens, according to US Centers for Disease Control and Prevention. CDC recommendations also encourage the use of molecular testing for CT/NG.

The expanded claims are in addition to those for male and female urine specimens, endocervical swab specimens, clinician-collected and patient self-collected vaginal swab specimens, and cervical specimens collected in PreservCyt Solution.

Roche's Cobas 6800 and 8800 systems are fully automated high throughput molecular diagnostic platforms able to process up to 384 tests or 960 tests in an eight-hour shift, respectively, and capable of performing three different tests in the same run with no pre-sorting required.

"The addition of Cobas CT/NG to our expanding Cobas 6800/8800 Systems menu provides laboratories with the highest throughput solution for the testing of CT/NG on the market," Uwe Oberlaender, head of Roche molecular diagnostics, said in a statement.