United States: The US Food and Drug Administration (FDA) authorized the marketing of an at-home STI diagnosis system for women about chlamydia, gonorrhea, and trichomoniasis on Friday of last week.
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The Visby Medical Women’s Sexual Health Test enables women who do have symptoms but also those who don’t to diagnose the three sexually transmitted infections (STIs).
The test delivers results through approximately thirty minutes of processing time.
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
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.
FDA Approves First At-Home Test to Diagnose Three STIs in Women https://t.co/KSQixneUl5
— Drugs.com (@Drugscom) April 2, 2025
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.