Testing for STIs at home

The marketing authorization was granted to Visby Medical.
March 31, 2025

The U.S. Food and Drug Administration (FDA) has granted marketing authorization for an at home chlamydia, gonorrhea, and trichomoniasis test.

The test, Visby Medical Women’s Sexual Health Test, is manufactured by Visby Medical. According to the FDA’s announcement, the test can be acquired over-the-counter and administered at home. Women can take the test regardless of symptoms and will receive results on an app in about 30 minutes.  

Additionally, “the Visby Medical Women’s Sexual Health Test 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.”

FDA release

About the Author

Erin Brady

Managing Editor

Erin Brady is Managing Editor of Medical Laboratory Observer.

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