United States: A home-based STI testing device for women to identify chlamydia, gonorrhea, and trichomoniasis received authorization from the US Food and Drug Administration (FDA) last week.
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Through the Visby Medical Women’s Sexual Health Test, women who have symptoms, as well as those who are asymptomatic, can detect the three sexually transmitted infections (STIs). The test requires a thirty-minute interval to supply the examination results.
A single-use at-home testing system requires a vaginal swab with an automated test device that connects securely to the Visby Medical App through its powers, as US News reported.
Fast & Accurate Diagnosis at Home
Today, we granted marketing authorization for the first diagnostic test for chlamydia, gonorrhea and trichomoniasis that can be purchased without a prescription and performed entirely at home. https://t.co/CZdxE3qpcw
— U.S. FDA (@US_FDA) March 28, 2025
The test is intended for females with or without symptoms and… pic.twitter.com/9T4z2tEadC
After testing is finished, the application will show the diagnostic results. The FDA recently approved this product after it issued authorization for an at-home syphilis diagnosis and the first chlamydia and gonorrhea diagnostic test with home sample collection capacity during 2023 for an STI except HIV.
Research data used in obtaining approval demonstrated the Visby Medical Women’s Sexual Health Test succeeded in detecting 98.8 percent and 97.2 percent of negative and positive Chlamydia trachomatis samples along with identifying 99.1 percent and 100 percent of negative and positive Neisseria vaginalis samples while correctly detecting 98.5 percent and 97.8 percent of negative and positive Trichomonas vaginalis samples.
According to the FDA, women who get positive results must speak with their physician.
Importance of Early Detection
Individuals who show symptoms or have recent STI exposure, along with people who have specific concerns, should perform extra testing procedures.
The Visby test carries similar risks to other tests by delivering false-negative findings that prolong treatment and false-positive results that trigger unwarranted treatment.
Furthermore, according to Courtney Lias, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA Center for Devices and Radiological Health, “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,” US News reported.