The FDA has granted marketing authorization to Visby Medical for the first at-home diagnostic test for chlamydia, gonorrhea and trichomoniasis that does not require a prescription.
The test includes a self-collected vaginal swab and a powered testing device that communicates the results through the Visby Medical App, according to a March 28 FDA news release.
In clinical evaluations, the test correctly identified more than 97% of positive cases and nearly 99% of negative cases for the three infections.
According to the CDC, more than 2.2 million combined cases of chlamydia and gonorrhea were diagnosed in the U.S. in 2023, and trichomoniasis affected an estimated 2.6 million people.
While the test provides a private and convenient option for sexual health screening, the FDA cautioned that false positive or negative results are possible, the release said.
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