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# FDA Green Lights At-Home Sexual Disease Test
- URL: https://www.fdaweb.com/fda-green-lights-at-home-sexual-disease-test/
- Published: 2025-03-28T12:00:00.000Z
- Updated: 2026-09-14T14:56:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158911

FDA has granted Visby Medical a de novo marketing clearance for its Women’s Sexual Health Test, a non-prescription at-home diagnostic test for chlamydia, gonorrhea and trichomoniasis. The single-use device includes a collection kit (self-collected vaginal swab) and a powered testing device, which communicates securely to Visby’s Medical App, according to the company. Results are available within 30 minutes and displayed on the app.

“In individuals with and without symptoms, 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,” an [FDA release](https://content.govdelivery.com/accounts/USFDA/bulletins/3d93397?ref=fdaweb.com) says.