FDA Approves First At-Home Test to Diagnose Three STIs in Women
By Tina Brown HealthDay Reporter
TUESDAY, April 1, 2025 -- The U.S. Food and Drug Administration granted marketing authorization for the first home-based, nonprescription diagnostic test for chlamydia, gonorrhea, and trichomoniasis in women, the agency announced Friday.
Women with or without symptoms can use the Visby Medical Women's Sexual Health Test to test for these three sexually transmitted infections (STIs). Results are delivered in about 30 minutes.
The single-use, at-home test includes a self-collected vaginal swab and a powered testing device that provides secure communication to the Visby Medical App. Once complete, the test results are displayed on the app.
This approval follows authorization of the first at-home syphilis test last year and authorization of the first diagnostic test for chlamydia and gonorrhea with at-home sample collection in 2023 -- the first FDA-authorized test with at-home sample collection for an STI other than HIV.
The approval was based on data showing the Visby Medical Women's Sexual Health Test correctly identified 98.8 and 97.2 percent of negative and positive Chlamydia trachomatis samples; 99.1 and 100 percent of negative and positive Neisseria vaginalis samples; and 98.5 and 97.8 percent of negative and positive Trichomonas vaginalis samples, respectively.
The FDA notes that women with positive results should consult with a physician. Those with symptoms, recent STI exposure, or other concerns should undergo additional testing. As with other tests, the main risks of using the Visby test are the possibility of false-negative results, leading to delays in treatment, or false-positive results, leading to unnecessary treatment.
"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," Courtney Lias, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA Center for Devices and Radiological Health, said in an agency news release.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted April 2025
Read this next
FDA Now Providing Daily Updates on Adverse Events
FRIDAY, Aug. 29, 2025 -- The U.S. Food and Drug Administration is now providing real-time, daily publication updates on adverse event data from its reporting system. In an...
At Least 95 Sickened in Salmonella Outbreak Linked To Recalled Eggs
FRIDAY, Aug. 29, 2025 — At least 95 people in 14 states have been sickened in a salmonella outbreak tied to recalled eggs, federal health officials say. Country Eggs LLC...
CDC Scales Back Foodborne Illness Tracking
FRIDAY, Aug. 29, 2025 — Federal health officials have cut back a long-running program that tracks foodborne illnesses in the United States. The Foodborne Diseases Active...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.