FDA Authorizes First At-Home Diagnostic Test for STIs in Women by Visby Medical
TL/DR –
The U.S. Food and Drug Administration (FDA) has approved Visby Medical’s at-home diagnostic kit for sexually transmitted infections (STIs) including chlamydia, gonorrhea, and trichomoniasis. The Visby Medical Women’s Sexual Health Test provides results in about 30 minutes and can be purchased without a prescription; it correctly identified 97.2-100% of positive samples and 98.5-99.1% of negative samples for the three STIs during trials. This approval follows last year’s authorization of the first at-home syphilis test and a diagnostic test for chlamydia and gonorrhea that includes at-home sample collection.
FDA Approves Visby Medical’s At-Home Sexual Health Test for Women
On March 28, 2025, Visby Medical received marketing authorization from the U.S. Food and Drug Administration for their Women’s Sexual Health Test. Being the first FDA-authorized at-home diagnostic test for chlamydia, gonorrhea, and trichomoniasis, it can be bought over-the-counter and used at home, providing results in 30 minutes.
“Ensuring access to at-home sexual health tests increases diagnosis rates and reduces infection spreads,” said Courtney Lias, Ph.D., director of the FDA’s Office of In Vitro Diagnostic Devices.
According to the CDC’s Sexually Transmitted Infections (STI) Surveillance Report, over 2.2 million cases of chlamydia and gonorrhea were reported in the U.S. in 2023. The CDC’s treatment guidelines estimate that trichomoniasis impacts approximately 2.6 million people in the U.S., making it the most prevalent nonviral STI worldwide. Antibiotics can treat all three infections, but lack of treatment can lead to severe health issues, including infertility.
The Visby Medical Women’s Sexual Health Test is a one-time use self-testing kit that communicates securely with the Visby Medical App to deliver results. In tests, it correctly identified 98.8% of negative and 97.2% of positive Chlamydia trachomatis samples, 99.1% of negative and 100% of positive Neisseria gonorrhoeae samples, and 98.5% of negative and 97.8% of positive Trichomonas vaginalis samples.
Patients with positive results or symptoms, recent exposure to an STI, or concerns despite a negative result are advised to seek medical care. The test carries the potential risks of false positive or false negative results, which could delay treatment or result in unnecessary treatment, respectively.
In review under the FDA’s De Novo premarket review pathway, this authorization establishes a new regulatory classification, which could streamline the marketing authorization process for similar future devices.
This closely follows last year’s authorization of the first at-home syphilis test and the first diagnostic test for chlamydia and gonorrhea with at-home sample collection in 2023.
About FDA
The FDA ensures public health by assuring the safety, effectiveness, and security of medical devices, drugs, vaccines, and more. It also regulates the nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and tobacco products.
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