The first-ever at-home, prescription-free sexually transmitted illness testing kit has been approved by the U.S. Food and Drug Administration (FDA). However, it’s not for everyone.
On Friday, the FDA granted marketing authorization for the diagnostic test, the Visby Medical Women’s Sexual Health Test, to Visby Medical. The FDA claims that the at-home kit is the first of its kind to test for trichomoniasis, gonorrhea, and chlamydia—three of the most prevalent STIs with symptoms that are frequently missed.
Female patients with or without symptoms are the target audience for the kit. A vaginal swab and a powered testing gadget that links to the Visby Medical App are included in this single-use item. After testing, results are shown on the app around half an hour later.
The test was 97% to 100% accurate in determining if the three STIs were present in women with or without symptoms, according to a press release from the FDA released on Friday. According to the press release, people who test positive should get medical attention, and even if they receive a negative result, they should still get in touch with their healthcare practitioner if they have symptoms, recent exposure, or other worries.
“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.
Three common STIs are addressed by an at-home test
Among the most common STIs in the United States are trichomoniasis, gonorrhea, and chlamydia. Trichomonas is a parasite infection, whereas chlamydia and gonorrhea are both bacterial illnesses. According to the Centers for Disease Control and Prevention (CDC), gonorrhea frequently has no symptoms but can cause infection in the throat, genitalia, and rectum. Although chlamydia usually has no symptoms, it can harm a woman’s reproductive system permanently.
Trichomonas vaginalis, a type of microscopic parasite, is the one-celled protozoan that causes trichomoniasis. According to the CDC, over 2.6 million Americans had trichomoniasis in 2021. When infected, up to 70% of persons show no symptoms.
Gonorrhea was the second most frequent STI in the United States in 2023, with 601,319 cases reported, according to the CDC’s (STI) Surveillance Report. Chlamydia is the most prevalent, with over 1.6 million cases reported in a single year.
