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Roche : FDA Okays To Expand Testing Menu For Sexually Transmitted Diseases

Roche (RHHBY.PK) said that it received a clearance from the US Food and Drug Administration to expand testing menu on cobas 6800/8800 Systems for sexually transmitted diseases. The addition of the cobas TV/MG test to the testing menu provides the flexibility to process up to four sexually transmitted infections from one patient sample.

"The launch of cobas TV/MG continues our expansion of our STI menu, giving healthcare providers and their patients greater access to more information from a single sample," said Mario Torres, Head of Roche Molecular Diagnostics.

Roche announced US Food and Drug Administration 510(k) clearance for the cobas TV/MG test for use on the cobas 6800/8800 Systems for the detection of Trichomonas vaginalis and/or Mycoplasma genitalium DNA in both symptomatic and asymptomatic patients.

Laboratories can now simultaneously process from a single patient sample a combination of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium, which provides clinicians the information they need to screen and diagnose sexually transmitted infections (STIs) and improve patient care.

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