Roche: US FDA OKs Cobas CT/NG For Cobas 6800/8800 Systems

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(RTTNews.com) - Swiss drug major Roche ( RHHBY ) Monday said the US Food and Drug Administration, or the FDA, has granted 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 DNA in both symptomatic and asymptomatic individuals.

The company noted that 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, clinician-collected vaginal swab specimens, endocervical swab specimens and cervical specimens collected in PreservCyt Solution.

Uwe Oberlaender, Head of Roche Molecular Diagnostics, said in a statement, "Sexually transmitted infection rates are rising worldwide and the cobas CT/NG helps labs meet increasing testing volumes with highest throughput solution on the market today".

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