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.