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FDA Clears Roche CT/NG Assay for 6800, 8800 Systems

NEW YORK (GenomeWeb) – Roche said today that the US Food and Drug Administration has provided 510(k) clearance for its Cobas CT/NG assay for use on its Cobas 6800 and 8800 systems. The assay and systems have been cleared to directly detect the DNA of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) in symptomatic and asymptomatic individuals.

The Cobas CT/NG real-time PCR assay is the first available in the US for the testing of sexually transmitted infections (STI) on the Cobas 6800 and 8800 systems, Roche said. The firm noted that the FDA has cleared its assay 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 collected in Cobas PCR media; and cervical specimens collected in PreservCyt Solution.

Uwe Oberlaender, head of Roche Molecular Diagnostics, said in a statement that its CT/NG assay helps labs meet increasing testing volumes with a high-throughput solution and frees up staff "to perform other tasks while still ensuring clinicians receive accurate and rapid results to aid in patient management." 

Roche said that it is developing other STI assays that will further allow laboratories to consolidate high-volume STI testing on a single platform. In addition to Cobas CT/NG, the firm's 6800 and 8800 systems' menu in the US includes viral load monitoring tests for HIV, HBV, HCV, and CMV, as well as MPX, WNV, DPX and Zika for use in screening blood donations.