FDA grants marketing authorization to at-home diagnostic test for STIs

Today, March 28, 2025, the FDA granted de novo marketing clearance to Visby Medical Women’s Sexual Health Test for the detection of sexually transmitted infections (STIs) caused by chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in women with or without symptoms.¹

The main risks associated with this test include the possibility of false negative and false positive results.

The at-home test can deliver diagnostic results in approximately 30 minutes. According to the FDA, this is the first approved diagnostic test for chlamydia, gonorrhea, and trichomoniasis that can be purchased without a prescription and used at home.

The test was previously granted 510(k) clearance and a CLIA waiver for point-of-care administration during patient visits.²

“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,” explained Courtney H. Lias, PhD, director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health, in the news release.¹ “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.”

According to the FDA, “The Visby Medical Women’s Sexual Health Test is a single-use, at-home test, that includes a collection kit (self-collected vaginal swab) and a powered testing device, which communicates securely to the Visby Medical App, which displays results when the test is complete.”

No separate instrument or reader is needed, according to Visby Medical.³

The authorization was supported by data from a study that included women with and without symptoms. In assessing for Chlamydia trachomatis, the test was able to correctly identify 98.8% of negative samples and 97.2% of positive samples. In assessing for Neisseria gonorrhoeae, the test correctly identified 99.1% of negative samples and 100% of positive samples. The test also detected 98.5% of true negative and 97.8% of true positive Trichomonas vaginalis samples.

According to the FDA, the main risks associated with this test include the possibility of false negative and false positive results, similar to other diagnostic tests.

The agency explained, “False negative test results can result in delays to effective treatment and spread of infection to other persons. False positive results could lead to unnecessary treatment and/or a delay in receiving a correct diagnosis and appropriate treatment.”

The test was approved through the FDA’s de novo premarket review pathway, which is intended for novel devices with a low- to moderate-risk.

They added, “Today’s action also opens the 510(k) pathway for other home tests for sexually transmitted infections.”

REFERENCES

1. FDA grants Marketing Authorization of first home test for chlamydia, gonorrhea and trichomoniasis. News release. US Food & Drug Administration. Published online and accessed March 28, 2025. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-home-test-chlamydia-gonorrhea-and-trichomoniasis

2. Visby Medical receives FDA clearance and CLIA waiver at the point of care for PCR Sexual Health Test. News release. Visby Medical. August 30, 2021. Accessed March 28, 2025. https://www.visbymedical.com/news/visby-medical-receives-fda-clearance-and-clia-waiver-at-the-point-of-care-for-pcr-sexual-health-test/

3. Sexual Health Test. Visby Medical. Accessed March 28, 2025. https://www.visbymedical.com/sexual-health-test/