FDA approves Visby’s test for at-home STI identification

FDA approves Visby’s test for at-home STI identification | Image Credit: © Tada Images - © Tada Images - stock.adobe.com.

The Visby Medical Women’s Sexual Health Test has received marketing authorization from the FDA for testing chlamydia, gonorrhea and trichomoniasis.¹

This authorization makes Visby’s test the first that patients can purchase and use entirely at home without a prescription. Female patients both with and without symptoms may use the test, receiving results in approximately 30 minutes.

“Home tests can give people information about their health from the privacy of their home,” said Courtney Lias, PhD, director at the FDA’s Center for Devices and Radiological Health. “This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment.”

There were over 2.2 million cases of chlamydia and gonorrhea in the United States in 2023, according to the Centers for Disease Control and Prevention. Additionally, approximately 2.6 million US cases of trichomoniasis have been reported, highlighting its prevalence as the most common sexually transmitted infection (STI) worldwide.

There were over 2.2 million cases of chlamydia and gonorrhea in the United States in 2023, according to the Centers for Disease Control and Prevention.² Additionally, approximately 2.6 million US cases of trichomoniasis have been reported, highlighting its prevalence as the most common sexually transmitted infection (STI) worldwide.

While these conditions may be treated with antibiotics, failure to treat them may lead to severe health outcomes such as infertility.¹ Using Visby’s single-use, at-home test, patients may receive test results through the Visby Medical App when the test is complete. It includes a collection kit and a powered testing device.

The test correctly identified 98.8% of negative Chlamydia trachomatis samples and 97.2% of positive samples in women with and without symptoms. For Neisseria gonorrhoeae samples, these rates were 99.1% and 100%, respectively, and for Trichomonas vaginalis samples, they were 98.5% and 97.8%, respectively.

The FDA recommends medical care be provided to individuals with a positive result for any of the 3 conditions. Additionally, further testing should be given to patients with recent exposure to an STI or other concerns even if they received a negative test result.

Similar to other tests, the primary risks of the Visby Medical Women’s Sexual Health Test include the chances of false positive and false negative results. The FDA warned that false negatives may delay treatment and allow the infection to spread to other individuals, while false positives may lead to unnecessary treatment or a delay in receiving the correct diagnosis.

The test was reviewed under the FDA’s De Novo premarket review pathway, designed for assessing new low- to moderate-risk devices. Additionally, the FDA has begun to develop controls to clarify necessary labeling and performance testing processes. This will improve safety and efficacy assurance for tests.

“This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket notification process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device,” wrote the FDA.

References

1. FDA grants marketing authorization of first home test for chlamydia, gonorrhea and trichomoniasis. US Food and Drug Administration. March 28, 2025. Accessed March 28, 2025. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-home-test-chlamydia-gonorrhea-and-trichomoniasis.
2. Sexually transmitted infections treatment guidelines, 2021. Centers for Disease Control and Prevention. Accessed March 28, 2025. https://www.cdc.gov/std/treatment-guidelines/trichomoniasis.htm