The U.S. Food and Drug Administration has granted marketing authorization to Visby Medical for the Visby Medical Women’s Sexual Health Test. This test, which can diagnose chlamydia, gonorrhea, and trichomoniasis, is the first of its kind available for purchase without a prescription and can be performed entirely at home. Results are delivered in approximately 30 minutes.
Courtney Lias, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health, stated, “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.” She added, “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 Centers for Disease Control and Prevention's STI Surveillance Report from 2023 revealed over 2.2 million cases of chlamydia and gonorrhea in the U.S., while trichomoniasis, estimated to affect 2.6 million people nationwide, is noted as the most prevalent nonviral STI globally. All three infections can usually be treated with antibiotics, but they can cause significant health complications, including infertility, if untreated.
The FDA's authorization of the Visby Medical Women’s Sexual Health Test includes a self-collected vaginal swab and a powered testing device. Once the test is completed, results are securely communicated to the Visby Medical App. When evaluated, the test accuracy was found to be high, correctly identifying 98.8% of negative and 97.2% of positive Chlamydia samples, 99.1% of negative and 100% of positive Gonorrhea samples, and 98.5% of negative and 97.8% of positive Trichomoniasis samples.
Anyone who receives positive test results is encouraged to seek medical care. Those with symptoms, recent exposure to an STI, or concerns despite negative results are advised to consult a healthcare provider for additional testing.
The FDA reviewed the test through its De Novo premarket review pathway, designed for low- to moderate-risk devices of a new type. This pathway, combined with established special controls, offers a new regulatory classification, potentially allowing for more efficient market entry for similar devices through the FDA’s 510(k) premarket notification process.
This authorization follows previous FDA approvals, such as last year's at-home syphilis test and the 2023 authorization of a chlamydia and gonorrhea test with at-home sample collection.
