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Roche Cobas TV/MG Test Gets CE-IVD Mark

NEW YORK (GenomeWeb) – Roche today announced it received the CE-IVD mark for the Cobas TV/MG test for use on the Cobas 6800/8800 systems.

The test allows for the direct detection of Trichomonas vaginalis and/or Mycoplasma genitalium DNA in symptomatic as well as asymptomatic patients. Roche launched the test today.

Cobas TV/MG has been validated for use with the same full set of female urogenital specimens that is used with Cobas NT/NG for Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae testing. It also has been validated for use with male urine, and, according to Roche, is the first CE-IVD molecular test to receive a claim for combo TV/MG testing using a meatal swab specimen.

"By coupling Cobas TV/MG with recently launched Cobas CT/NG … laboratories can now have the most flexible, high-throughput testing solution on the market today," Uwe Oberlaender, head of Roche Molecular Diagnostics, said in a statement. "Labs can now simultaneously process, from a single patient sample, any combination of CT, NG, TV, and MG, which provides clinicians the valuable information they need to properly [diagnose] STIs and improve patient care."

The Scan

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