The US Food and Drug Administration (FDA) today 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.

Expanding access to tests could boost diagnosis, treatment

Courtney Lias, PhD, director of the Office of In Vitro Diagnostic Devices in the FDA's Center for Devices and Radiological Health, said the ability to test at home is particularly important for patients who are concerned they may have a sexually transmitted infection and may experience fear or anxiety about getting tested, which could result in a delayed diagnosis.

"Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection," Lias said in an FDA press release.

According to the most recent data from the Centers for Disease Control and Prevention, more than 2.2 million US cases of gonorrhea and chlamydia were reported in 2023, while trichomoniasis affects roughly 2.6 million Americans. 

The FDA says it reviewed and approved the device under a new regulatory pathway that allows makers of medical devices to obtain marketing authorization by demonstrating substantial equivalence to an approved device.

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