Roche receives FDA clearance to expand testing menu on cobas 6800/8800 Systems for sexually transmitted diseases

Roche has announced US Food and Drug Administration (FDA) 510(k) clearance for the cobas^® TV/MG test for use on the cobas^® 6800/8800 Systems for the detection of Trichomonas vaginalis (TV) and/or Mycoplasma genitalium (MG) DNA in both symptomatic and asymptomatic patients. Laboratories can now simultaneously process from a single patient sample a combination of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG), which provides clinicians the information they need to screen and diagnose sexually transmitted infections (STIs) and improve patient care.

The addition of the cobas TV/MG test continues the expansion of the testing menu on the cobas 6800/8800 Systems, supporting true consolidation and testing efficiencies. The cobas TV/MG test has been validated for use with broad specimen types, including sample types comparable to those available for use with the cobas^® CT/NG test: male/female urine; endocervical swabs and vaginal swabs (both clinician collected and patient collected in a clinical setting).

“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. “By coupling cobas TV/MG with the recently launched cobas CT/NG MC-US-04357 for the detection of Chlamydia trachoma tis (CT), Neisseria gonorrhoeae (NG), laboratories have a highly flexible, moderate complexity, high throughput automated solution to support their testing needs.”

“The addition of Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV) detection to the cobas 6800/8800 Systems is an important step forward in the ability to diagnose sexually transmitted infections.” said Barbara Van Der Pol, Associate Professor of Medicine, School of Medicine, University of Alabama at Birmingham. “These new analytes, in conjunction with the approved Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) molecular diagnostic assays, will support a more thorough assessment of the potential pathogens responsible for discharge-causing STI. As a result, clinicians can more easily identify co-infections and utilize appropriate treatment strategies earlier in the patient management process.”

The fully automated cobas 6800/8800 Systems promise the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms, providing laboratories with improved operating efficiency and the flexibility to adapt to changing testing demands.

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