FDA has granted premarket notification (510(k)) clearance to the Cobas TV/MG test by Roche Molecular Diagnostics, Pleasanton, Calif, for the detection of Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in specimens from both symptomatic and asymptomatic patients.

A menu expansion intended for use on Roche’s Cobas 6800 and 8800 molecular diagnostic systems, the new test will enable laboratories to simultaneously process from a single patient sample a combination of tests for Chlamydia trachomatis (CT), Mycoplasma genitalium, Neisseria gonorrhoeae (NG), and Trichomonas vaginalis. The tests provide 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 and 8800 systems, supporting consolidation and testing efficiencies. Since 2014, the Cobas 6800 and 8800 systems have established a new standard for routine molecular testing by delivering fully integrated, automated solutions that serve the areas of viral load monitoring, donor screening, sexual health, and microbiology. Based on Nobel prize-winning polymerase chain reaction technology, the systems deliver proven performance with full automation, increased throughput, fast turnaround time, and complete track connectivity. The systems are validated for molecular testing, and offer users the flexibility to consolidate their commercial in vitro diagnostic and laboratory-developed testing menus on a single system, while increasing overall workflow efficiencies.

The systems produce up to 96 results in about 3 hours. In an 8-hour shift, the Cobas 6800 can produce 864 results, while the Cobas 8800 can produce 1,824 results. Both instruments make it possible for labs to perform up to three tests in the same run with no presorting required. The systems also enable up to 8 hours (Cobas 6800) and 4 hours (Cobas 8800) of walkaway time, with minimal user interaction.

The Cobas TV/MG test has been validated for use with broad specimen types, including sample types comparable to those usable 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,” says Mario Torres, head of Roche Molecular Diagnostics. “By coupling Cobas TV/MG with the recently launched Cobas CT/NG for the detection of chlamydia and gonorrhea, laboratories have a highly flexible, moderate-complexity, high-throughput automated solution to support their testing needs.”

“The addition of Mycoplasma genitalium and Trichomonas vaginalis detection to the Cobas 6800 and 8800 systems is an important step forward in the ability to diagnose sexually transmitted infections,” says Barbara Van Der Pol, PhD, MPH, associate professor of medicine and director of the sexually transmitted diseases laboratory at the University of Alabama. “These new analytes, in conjunction with the approved Chlamydia trachomatis and Neisseria gonorrhoeae molecular diagnostic assays, will support a more thorough assessment of the potential pathogens responsible for discharge-causing STIs. As a result, clinicians can more easily identify coinfections and utilize appropriate treatment strategies earlier in the patient management process.”

The fully automated Cobas 6800 and 8800 systems offer a fast time to first result, high throughput, and a long walkaway time, providing laboratories with improved operating efficiency and the flexibility to adapt to changing testing demands.

For further information, visit Roche.

Featured image: Microphotograph of a wet mount vaginal discharge specimen showing the presence of the flagellated protozoan, Trichomonas vaginalis. Photo courtesy CDC Public Health Image Library (ID 5238).