The U.S. Food and Drug Administration approved the use of Hologic Inc.'s Aptima Combo 2 Assay and Danaher Corp. unit Cepheid's Xpert CT/NG to detect two sexually transmitted diseases.
These devices are the first ones approved by the U.S. regulator to detect chlamydia, an infection caused by certain bacteria that can cause permanent damage to the reproductive system. The devices are also approved to detect gonorrhea, an infection that results in an inflammatory discharge from the urethra or vagina — through diagnostic testing of specimens taken from the throat or rectum.
Previously, the FDA had cleared these tests to diagnose the diseases using samples taken from urine, the vagina and the lower part of the uterus.
Earlier on May 23, the FDA also expanded the use of Roche Holding AG's cobas test for use in cobas 6800/8800 Systems to detect two additional sexually transmitted diseases — trichomonas vaginalis and mycoplasma genitalium.