The FDA has granted marketing authorization to the Visby Medical Women’s Sexual Health Test, the first over-the-counter diagnostic device for chlamydia, gonorrhea, and trichomoniasis that may be purchased without a prescription and used entirely at home. The authorization establishes a new regulatory classification, opening the 510(k) pathway for similar sexually transmitted infection home testing devices.
The test is intended for use by individuals assigned female at birth, with or without symptoms, and delivers results in approximately 30 minutes. In clinical studies, the test demonstrated 97.2% sensitivity and 98.8% specificity for Chlamydia trachomatis, 100% sensitivity and 99.1% specificity for Neisseria gonorrhoeae, and 97.8% sensitivity and 98.5% specificity for Trichomonas vaginalis.
“Home tests can give people information about their health from the privacy of their home. This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment,” said Courtney Lias, PhD, director of the Office of In Vitro Diagnostic Devices in the FDA’s 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.”
The single-use diagnostic test includes a self-collected vaginal swab and a powered testing device that communicates securely with the Visby Medical App to display results upon completion.
According to the CDC Sexually Transmitted Infections Surveillance Report, more than 2.2 million cases of chlamydia and gonorrhea were diagnosed and reported in the U.S. in 2023. In addition, the CDC’s treatment guidelines estimate that trichomoniasis—the most prevalent nonviral sexually transmitted infection (STI) globally—affects approximately 2.6 million people in the U.S. All three infections are typically treatable with antibiotics but can cause serious health complications, including infertility, if left untreated.
Individuals who receive a positive result should seek medical care. Those with symptoms, recent exposure to an STI, or ongoing concerns despite a negative result should contact a health care provider for additional testing.
The FDA reviewed the test under the De Novo premarket review pathway, a regulatory route for novel low- to moderate-risk medical devices. The authorization includes special controls related to labeling and performance testing which, together with general controls, provide reasonable assurance of safety and effectiveness. This new classification permits future tests of the same type and intended use to pursue marketing authorization via the FDA’s 510(k) pathway, potentially reducing the burden for developers.
As with other diagnostic tools, the test carries risks of false-negative and false-positive results. A false negative may delay appropriate treatment and facilitate transmission to others, while a false positive could result in unnecessary treatment or delayed diagnosis of another condition.
This authorization follows the FDA’s 2023 authorizations of the first at-home syphilis test and the first diagnostic test for chlamydia and gonorrhea with at-home sample collection—neither of which allowed for fully at-home, over-the-counter testing. The Visby Medical Women’s Sexual Health Test is the first FDA-authorized home test for any STI other than HIV that does not require a prescription or clinical involvement.
Reference:
US Food and Drug Administration. FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-home-test-chlamydia-gonorrhea-and-trichomoniasis