FDA Approves First Fully At-Home Test for Three Common STIs

Credit: Visby Medical

The U.S. Food and Drug Administration (FDA) has approved the Visby Medical Women’s Sexual Health Test — the first-ever fully at-home test for chlamydia, gonorrhea and trichomoniasis. The test allows women to check for these common sexually transmitted infections (STIs) without a prescription and get results in about 30 minutes.

In the U.S., more than 2.2 million cases of chlamydia and gonorrhea were reported in 2023 and 2.6 million people are estimated to have trichomoniasis — presumed to be the most prevalent nonviral STI globally. While these infections are easily treated using antibiotics, they can cause serious health complications, including infertility, if left untreated.

This private, fast and reliable option for STI testing could help with early diagnosis and treatment, reducing the spread of infections.

“Home tests can give people information about their health from the privacy of their home,” said Courtney Lias, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health. “This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment.”

The single-use Visby Medical Women’s Sexual Health Test can detect STIs in women with or without symptoms using a collection kit (self-collected vaginal swab) and a powered testing device, which is linked to the Visby Medical App.

The test correctly identified 97.2% of positive cases of chlamydia and nearly 99% of negative cases, 99.2% of negative gonorrhea samples and 100% of positive samples, and 97.8% of positive cases of trichomoniasis and 98.5% of negative cases.

If results are positive, users should seek medical care. Those who still have concerns despite testing negatively should speak to their doctor about additional testing.