FDA Authorizes First At-Home Test for Multiple STIs, Marking Significant Advancement in Sexual Health Diagnostics

The U.S. Food and Drug Administration (FDA) has granted authorization for the first at-home test capable of detecting three common sexually transmitted infections (STIs): chlamydia, gonorrhea, and trichomoniasis. This landmark decision, announced on Friday, represents a significant step forward in accessible sexual health diagnostics and could potentially revolutionize STI testing and treatment.

Visby Medical's Groundbreaking Diagnostic

Visby Medical, a company that has been operating under the radar for several years, received the de novo authorization for their single-use, polymerase chain reaction (PCR) test. This innovative diagnostic allows women to self-collect vaginal swabs and analyze them using a powered testing device, all from the privacy of their own homes. Importantly, the test can be purchased without a prescription, further increasing its accessibility.

The FDA's decision to establish special controls as part of the de novo authorization creates a pathway for other companies to bring similar tests to market through the 510(k) clearance process. This move could potentially lead to a proliferation of at-home STI testing options in the near future.

Clinical Performance and Public Health Impact

The authorization was granted after Visby demonstrated the test's impressive clinical performance. The diagnostic correctly identified 97.2% of positive Chlamydia trachomatis samples and showed even higher accuracy for other infections, with 100% correct identification of positive Neisseria gonorrhoeae samples.

Courtney Lias, director of the Office of In Vitro Diagnostic Devices at the FDA, highlighted the importance of this development, stating that home testing "can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment."

The potential public health impact of this authorization is significant, considering that more than 2.4 million cases of syphilis, gonorrhea, and chlamydia were diagnosed and reported in the U.S. in 2023, according to the Centers for Disease Control and Prevention. Additionally, trichomoniasis, caused by a protozoan parasite, is estimated to be the most prevalent nonviral sexually transmitted infection globally, affecting 2.6 million people in the U.S. alone.

Visby Medical's Journey and Future Prospects

Visby Medical's path to this authorization has been marked by strategic developments and significant financial backing. The company first gained public attention when it won emergency use authorization for a COVID-19 test in 2020. By that time, Visby had already completed enrollment of 1,585 participants in a study of its sexual health test, demonstrating its long-term commitment to this area of diagnostics.

In 2022, Visby secured $135 million in funding, a clear indication of investor confidence in its technology and market potential. The company has also received 510(k) clearances for its first- and second-generation sexual health tests, which allowed healthcare professionals to use the tests in clinical settings.

As the landscape of at-home sexual health testing continues to evolve, Visby's authorization adds to a growing list of available options. The FDA had previously authorized the first test for chlamydia and gonorrhea with at-home sample collection in 2023 and the first at-home syphilis test in 2024. This latest development further expands the range of STIs that can be detected through home testing, potentially improving access to early diagnosis and treatment for millions of Americans.