FDA

FDA greenlights first at-home test for chlamydia, gonorrhea and trichomoniasis

March 31, 2025

FDA granted marketing authorization to Visby Medical for the first at-home diagnostic test for chlamydia, gonorrhea, and trichomoniasis. The test is available without a prescription and allows women to self-collect samples and receive results in approximately 30 minutes. In individuals with or without symptoms, the test demonstrated high accuracy, identifying 98.8% of negative and 97.2% of positive chlamydia samples, 99.1% of negative and 100% of positive gonorrhea samples, and 98.5% of negative and 97.8% of positive trichomoniasis samples. This innovation aims to reduce the stigma and anxiety associated with STI testing, promoting earlier diagnosis and treatment. The agency said that future home STI tests can also be approved through the 510(k) pathway if they demonstrate substantial equivalence to the Visby Medical Women's Sexual Health Test.

Source:

(2025, March 28). FDA. FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-home-test-chlamydia-gonorrhea-and-trichomoniasis