Application submitted to FDA for 510(k) clearance of Men’s Sexual Health Test

Visby Medical has submitted an application to the FDA seeking 510(k) clearance and a clinical laboratory improvement amendments (CLIA) waiver for its point-of-care (POC) Men’s Sexual Health Test, the company shared in a news release.¹

Visby Medical has announced plans to expand its OTC and POC offerings.

The single-use, instrument-free test is designed to deliver polymerase chain reaction (PCR) diagnostic results for chlamydia and gonorrhea in approximately 30 minutes using male urine samples. The test can be conducted in men with or without symptoms.

According to Visby Medical, the diagnostic requires “no capital investment, maintenance, or refrigeration, which allows easy integration into diverse clinical settings including urgent care centers, community health clinics, and physician offices.”

"This submission brings Visby Medical's comprehensive sexual health diagnostic portfolio one step closer to achieving yet another groundbreaking advance in the fight against sexually transmitted infections (STIs), which affect 20% of the US population, according to the CDC," said Gary Schoolnik, MD, chief medical officer of Visby Medical, in the news release from the company.¹ "Men are especially prone to being lost to follow-up after testing, so the streamlined process provided by our Men's Sexual Health Test addresses [a] clinical need because it streamlines the test-to-treat process with the PCR accuracy that Visby Medical is known for."

Visby Medical’s portfolio

The submission for the Men’s Sexual Health Test comes on the heels of the FDA granting a de novo authorization to the Visby Medical Women’s Sexual Health Test for over-the-counter (OTC) use in March 2025. The test was approved for the detection of STIs caused by chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in women with or without symptoms.

With this clearance, the test became the first PCR diagnostic device approved for at-home use in any indication. The Visby Medical Women’s Sexual Health Test was initially approved for POC use in March 2023.

The OTC authorization was supported by data from a study in symptomatic and asymptomatic women.³ 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,³ the main risks associated with this test include the possibility of false negative and false positive results, in accordance with other diagnostic tests.

A companion app is offered alongside the at-home test to guide users through the process of sample collection, test execution, and result interpretation. There is no separate instrument or reader needed.

In addition to Visby’s sexual health tests, the company was also granted 510(k) clearance and a CLIA waiver in February 2025 for its Respiratory Health Test for influenza A and B and SARS-CoV-2 (COVID-19). The company has also announced plans to expand its OTC and POC offerings, with hopes to offer a test to address urinary tract infections, among other conditions.

REFERENCES

1. Visby Medical submits Men's Sexual Health Test to FDA for clearance and CLIA waiver. News release. Visby Medical. May 27, 2025. Accessed May 27, 2025. https://www.prnewswire.com/news-releases/visby-medical-submits-mens-sexual-health-test-to-fda-for-clearance-and-clia-waiver-302465364.html

2. Visby Medical receives landmark FDA de novo authorization for first-ever OTC PCR test for sexual health. News release. Visby Medical. March 28, 2025. Accessed May 27, 2025. https://www.visbymedical.com/news/visby-medical-receives-landmark-fda-de-novo-authorization-for-first-ever-otc-pcr-test-for-sexual-health/

3. FDA grants marketing authorization of first home test for chlamydia, gonorrhea and trichomoniasis. News release. US Food & Drug Administration. March 28, 2025. Accessed May 27, 2025. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-home-test-chlamydia-gonorrhea-and-trichomoniasis