“The US Food and Drug Administration (FDA) today (3/28/25) approved the first at-home, over-the-counter test for chlamydia, gonorrhea, and trichomoniasis.

The Visby Medical Women’s Sexual Health Test is a single-use test intended for women with or without symptoms. The FDA granted marketing authorization to Visby Medical based on testing that showed the device correctly identified 98.8% of negative and 97.2% of positive Chlamydia trachomatis samples, 99.1% of negative and 100% of positive Neisseria gonorrhoeae samples, and 98.5% of negative and 97.8% of positive Trichomonas vaginalis samples.

The test, which includes a sample collection kit and a powered testing device that communicates testing results to an app, can be bought without a prescription and deliver results within 30 minutes.”

From CIDRAP.