FDA approves first at-home, over-the-counter test for STIs. But there's a catch.

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The U.S. Food and Drug Administration (FDA) has approved the first-ever testing kit for sexually transmitted infections that can be taken at home without a prescription. But it's not for everyone.

The FDA granted marketing authorization for the diagnostic test, the Visby Medical Women’s Sexual Health Test, to Visby Medical on Friday. The at-home kit, according to the FDA, is the first of its kind to test for chlamydia, gonorrhea and trichomoniasis, three of the most common STIs with symptoms that often go unnoticed.

The kit is intended for use in female patients with or without symptoms. It is single-use and includes a vaginal swab and a powered testing device that connects to the Visby Medical App. Results are displayed on the app about 30 minutes after testing.

An FDA press release issued Friday said the test was 97% to 100% accurate when identifying the presence or absence of the three STIs in women with or without symptoms. The release advised that those who test positive should seek medical care and those who have symptoms, recent exposure or other concerns should still contact their healthcare provider even if they get a negative result.

“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,” Courtney Lias, director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health, said in a statement.

“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 approval of this test opens the pathway for more at-home STI testing in the future, said the statement.

At-home test tackles three most common STIs

Chlamydia, gonorrhea and trichomoniasis are three of the most prevalent STIs in the U.S.

Both chlamydia and gonorrhea are bacterial infections, while trichomoniasis is caused by a parasite. Gonorrhea can cause infection in the genitals, rectum and throat and often has no symptoms, according to the Centers for Disease Control and Prevention (CDC). Chlamydia is also typically asymptomatic but can cause permanent damage to a woman's reproductive system.

Trichomoniasis is caused by a one-celled protozoan, a type of tiny parasite called Trichomonas vaginalis. In 2021, the CDC reported that around 2.6 million Americans had been infected with trichomoniasis. Up to 70% of people have no symptoms when infected.

According to the CDC's (STI) Surveillance Report, 601,319 cases of gonorrhea were reported in the U.S. in 2023, making it the second most common STI in the country. There were more than 1.6 million reported cases of chlamydia in the same year, making it the most common.