Visby Medical Women’s Sexual Health Test is a prescription-free test that has received approval from the Food and Drug Administration (FDA) for an innovative at-home diagnostic solution. This test is highly accessible and helps in early detection of disease and treatment.
Chlamydia, gonorrhea, and trichomoniasis are sexually transmitted infections (STIs) that can be easily detected by this test. It is mostly applicable to a female who experiences symptoms or not. This test provides accurate results in 30 minutes.
Courtney Lias (Ph.D.), Director of the Office of In Vitro Diagnostic Devices, stated that people with fear or anxiety who refrain from seeking external tests may lead severe complicated infections; therefore, increasing access to STI tests that can be done at home may help in early diagnosis and treatment.
The CDC reported that more than 2.2 million cases of chlamydia and gonorrhea were documented in the United States and 2.6 million cases of Trichomoniasis. If these conditions are left untreated, they could lead to severe health complications. This test is a powered testing device with a self-collected vaginal swab that is integrated with Visby Medical App. Once the test is successfully completed the app immediately presents the results.
The studies showed that this test yields a high accuracy in detecting infections, with 100% positive and 99.1% negative accuracy for gonorrhea, 97.2% positive and 98.8% negative for chlamydia, and 97.8% positive and 98.5% negative for trichomoniasis.
The approval is expected to have significant public health benefits by encouraging individuals to get tested at home, providing a convenient and private testing option. This significantly leads to early diagnosis and treatment, which prevents the spread of infections.
The FDA cautioned about the risks linked to the test by highlighting the potential for false positive and false negative results. There may be delays in effective treatment for false negatives that contribute to the spread of infection, while false positives could lead to unnecessary treatment, and delays in receiving the correct diagnosis.
The FDA evaluated this test through the De Novo premarket review pathway and applied it to a new category of low-to-moderate-risk devices. It also established special controls over labeling and performance testing and are associated with general controls and assure the safety and efficacy of the tests for this type.
This decision also opens the 510(k) pathway for other home tests for sexually transmitted infections, which could potentially save the developers time and expense compared to other review pathways.
This test marks a significant advancement in STI diagnostics and makes it more accessible. It potentially improves public health outcomes by allowing individuals to test themselves conveniently at their homes and reduces the spread of sexually transmitted infections. With technological advancements as sexual health testing continues to evolve, it provides new opportunities for early detection, prevention of STI transmission, and timely treatment.
Reference: U.S. Food and Drug Administration. FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis. Published March 28, 2025. FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis | FDA
