FDA Grants Marketing Authorization to At-Home Chlamydia and Gonorrhea Test

The FDA has granted marketing authorization to Visby Medical for the Visby Medical Women’s Sexual Health Test.

The test is the “first diagnostic test for chlamydia, gonorrhea, and trichomoniasis that can be purchased without a prescription and performed entirely at home.” It can deliver results in approximately 30 minutes.

According to the CDC, “more than 2.2 million cases of chlamydia and gonorrhea were diagnosed and reported in the U.S. in 2023. Additionally, it is estimated that trichomoniasis is the most prevalent nonviral STI worldwide, affecting approximately 2.6 million people in the U.S.” All three infections can typically be treated with antibiotics, “but if left untreated, [they] can cause serious health complications for patients, including infertility.”

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 those with and without symptoms, the test correctly identified 97% to 100% of the negative and positive results for the three infections. Individuals with positive results should seek medical care, and those with concerns despite a negative result “should contact their healthcare provider for additional testing.”