The U.S. Food and Drug Administration granted marketing authorization to Visby Medical for the Visby Medical Women’s Sexual Health Test.
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This is the first diagnostic test for chlamydia, gonorrhea and trichomoniasis that can be purchased without a prescription and performed entirely at home.
The test is intended for females with or without symptoms and delivers results in approximately 30 minutes.
Typically, all three infections can be treated with antibiotics, but if left untreated, can cause serious health complications for patients, including infertility.
“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, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health.
The Visby Medical Women’s Sexual Health Test is a single use, at home test, that includes a collection kit (self-collected vaginal swab) and a powered testing device, which communicates securely to the Visby Medical App, which displays results when the test is complete.
In individuals with and without symptoms, the Visby Medical Women’s Sexual Health Test 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.
Individuals with positive results for any of the three infections should seek medical care. Individuals with symptoms, recent exposure to an STI or other concerns despite a negative result should contact their health care provider for additional testing.
This announcement follows last year’s authorization of the first at-home syphilis test, as well as the authorization of the first diagnostic test for chlamydia and gonorrhea with at-home sample collection in 2023, which was the first FDA-authorized test with at-home sample collection for any sexually transmitted infection other than HIV. ■
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