FDA Approves First At-Home Test for STIs

Revolutionizing Sexual Health: FDA Approves First At-Home Test for STIs

In a groundbreaking move for public health, the U.S. Food and Drug Administration (FDA) has granted Visby Medical the authorization to market the first-ever at-home, over-the-counter diagnostic test capable of detecting chlamydia, gonorrhea, and trichomoniasis. This innovative health solution is set to transform the landscape of sexual health, allowing individuals to take control of their well-being from the comfort of their homes.

What is the Women’s Sexual Health Test?

The newly approved Women’s Sexual Health Test is designed specifically for women, regardless of whether they show symptoms. Using a simple vaginal swab, results are delivered in an impressive 30 minutes, providing swift and private insight into personal health. According to the FDA’s press release dated March 28, 2025, access to this test is especially critical for those who may feel fear or anxiety about seeking traditional STI testing.

Courtney Lias, PhD, director of the Office of In Vitro Diagnostic Devices at the FDA, emphasizes the importance of accessibility in sexual health care: “Home tests can give people information about their health from the privacy of their home. Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis.”

Understanding the Risks Involved

While the convenience of at-home testing brings numerous benefits, users should be mindful of the potential for false positive and negative results. Misinterpretation of these results can lead to unnecessary treatment or delays in proper medical care. Therefore, it is critical for individuals who receive a positive result to seek medical advice promptly.

The Importance of Addressing STIs

The statistics surrounding sexually transmitted infections (STIs) underscore the significance of this test. In 2023, the CDC reported over 2.2 million cases of chlamydia and gonorrhea in the U.S. alone. Furthermore, trichomoniasis is estimated to affect around 2.6 million individuals, making it the most prevalent nonviral STI worldwide. Left untreated, these infections can result in severe complications, including infertility.

How Does the Test Work?

The Visby Medical Women’s Sexual Health Test involves a self-collected vaginal swab and a powered testing device that securely transmits results to the Visby Medical App. Clinical evaluations of the product have shown remarkable accuracy:

Chlamydia trachomatis: 98.8% of negative and 97.2% of positive results.

Neisseria gonorrhoeae: 99.1% of negative and 100% of positive results.

Trichomonas vaginalis: 98.5% of negative and 97.8% of positive results.

These figures demonstrate the test’s potential to significantly enhance STI detection rates.

The Path to FDA Approval

The test received its authorization through the De Novo premarket review pathway, specifically designed for innovative devices that pose low to moderate risk but represent new categories of products. This approval lays the groundwork for future at-home STI tests to potentially obtain FDA clearance through streamlined processes.

Following this historic approval, it is worth noting that the FDA had also authorized the first at-home syphilis test just months earlier, in August 2024.

Conclusion

The introduction of the Women’s Sexual Health Test by Visby Medical marks a pivotal advancement in sexual health management. Not only does it empower individuals to take charge of their sexual health privately and conveniently, but it also aims to reduce the spread of STIs through timely diagnoses and treatment. As more at-home testing options emerge, we move towards a future where sexual health is more accessible and less stigmatized.

References:

FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis. News release. FDA. March 28, 2025. Read More.

Jennings S. STI Epidemic in US Shows Signs of Slowing, According to New CDC Report. Patient Care Online. November 13, 2024. Read More.

Centers for Disease Control and Prevention. Trichomoniasis – STI treatment guidelines, 2023. CDC. Updated July 22, 2023. Read More.

Jennings S. First At-Home, OTC Syphilis Test Granted Marketing Authorization by FDA. Patient Care Online. August 19, 2024. Read More.