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Roche's test gets FDA nod for detecting 2 more sexually transmitted diseases

The U.S. Food and Drug Administration expanded the use of Roche Holding AG's cobas test for use in cobas 6800/8800 Systems to detect two additional sexually transmitted diseases.

The Switzerland-based pharmaceutical giant's test can now be used for detecting trichomonas vaginalis, the most common nonviral sexually transmitted infection in the world. It is also approved to detect Mycoplasma genitalium, a sexually transmitted bacterium that lives on the skin cells of the urinary and genital tracts in humans. The test can detect the diseases in patients irrespective of whether they show any symptoms or not.

The test was previously approved to detect chlamydia and gonorrhea on the cobas 6800/8800 systems.

Roche said in a May 23 press release that the test now provides the flexibility to process up to four sexually transmitted infections from one patient sample.

In the U.S., the cobas 6800/8800 systems are also used for viral load monitoring tests for HIV and hepatitis B virus, among other diseases.