The U.S. Food and Drug Administration (FDA) has given the green light to the first-ever at-home testing kit for sexually transmitted infections (STIs) that can be used without a prescription. However, it’s important to note that this test is specifically designed for women.
Visby Medical’s Women’s Sexual Health Test has received marketing authorization from the FDA, making it the first of its kind to test for chlamydia, gonorrhea, and trichomoniasis. These three common STIs often go unnoticed due to their asymptomatic nature.
The at-home kit is intended for use by female patients with or without symptoms. It is a single-use kit that includes a vaginal swab and a testing device that connects to the Visby Medical App. Results can be viewed on the app approximately 30 minutes after testing.
According to an FDA press release, the test has shown a high level of accuracy (97%-100%) in identifying the presence or absence of these STIs in women, regardless of symptoms. The release advises individuals who test positive to seek medical care and recommends that those with symptoms, recent exposure, or other concerns should consult their healthcare provider even if they receive a negative result.
Courtney Lias, the director of the Office of In Vitro Diagnostic Devices at the FDA, highlighted the importance of at-home tests in providing individuals with privacy and convenience in managing their sexual health. The approval of this test sets the stage for potential future developments in at-home STI testing.
Chlamydia, gonorrhea, and trichomoniasis are among the most common STIs in the U.S. With chlamydia and gonorrhea being bacterial infections, and trichomoniasis caused by a parasite, these STIs can have serious health consequences if left untreated.
The availability of at-home testing for these STIs marks a significant step towards earlier detection, timely treatment, and reduced transmission of infections. This advancement in healthcare aims to empower individuals to take control of their sexual health from the comfort of their own homes.
