FDA approves marketing of first at-home test for chlamydia, gonorrhea, and trichomoniasis

FDA approves marketing of at-home STI test: ©Pawel - stock.adobe.com

The U.S. Food and Drug Administration has granted marketing authorization to Visby Medical for the Visby Medical Women’s Sexual Health Test, the first at-home diagnostic test for chlamydia, gonorrhea, and trichomoniasis that does not require a prescription. The test, which is designed for females regardless of symptoms, delivers results in approximately 30 minutes.

"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," said Courtney Lias, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health. "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 FDA’s authorization comes at a time when sexually transmitted infections remain a significant public health concern. According to the Centers for Disease Control and Prevention, more than 2.2 million cases of chlamydia and gonorrhea were diagnosed and reported in the U.S. in 2023. Additionally, trichomoniasis is estimated to be the most prevalent nonviral STI worldwide, affecting approximately 2.6 million people in the U.S.

The Visby Medical Women’s Sexual Health Test consists of a single-use collection kit with a self-collected vaginal swab and a powered testing device that securely communicates results to the Visby Medical App. The test demonstrated high accuracy in clinical evaluations, correctly identifying 98.8% of negative and 97.2% of positive chlamydia samples, 99.1% of negative and 100% of positive gonorrhea samples, and 98.5% of negative and 97.8% of positive trichomoniasis samples.

While the test provides a convenient and private option for STI screening, the FDA advises that individuals who receive positive results should seek medical care. Those with symptoms or concerns despite a negative result should consult a health care provider for further testing. The agency also noted the potential risks of false positives and false negatives, which could lead to unnecessary treatment or delays in proper diagnosis and care.

The FDA reviewed the test under its De Novo premarket review pathway, a process for low- to moderate-risk devices that are novel in type. The decision establishes a new regulatory classification, streamlining future approvals of similar tests through the FDA’s 510(k) premarket notification process.

This authorization follows last year’s approval of the first at-home syphilis test and the 2023 authorization of a diagnostic test for chlamydia and gonorrhea that allowed for at-home sample collection.