#United States #San Jose #Visby Medical #Sexual Health #FDA Test

Visby Medical's Innovative Men's Sexual Health Test

In an important stride towards enhancing men's sexual health diagnostics, Visby Medical™ has recently submitted its Men's Sexual Health Test to the U.S. Food and Drug Administration (FDA) for clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver. This pioneering test promises quick and accurate Polymerase Chain Reaction (PCR) results for Chlamydia and Gonorrhea detection, utilizing male urine samples. As sexually transmitted infections (STIs) escalate, this development could play a crucial role in public health interventions.

Fast and Accurate Testing

The Visby Medical Men's Sexual Health Test is designed to deliver results in under 30 minutes, catering to both symptomatic and asymptomatic men. This rapid turnaround is vital, especially at a time when STIs threaten public health across the nation. The test’s streamlined process not only improves the speed of diagnosis but also facilitates quicker treatment, addressing a critical gap where many men often fall out of follow-up care after testing.

Designed for Accessibility

What sets this test apart is its single-use, instrument-free design, promoting easy integration into various clinical environments. No major capital investment, maintenance, or refrigeration is necessary, making it an excellent option for urgent care centers, community clinics, and physician offices. This innovative approach ensures that healthcare providers can swiftly respond to the growing demand for accessible sexual health testing while adhering to established medical guidelines.

Historical Context and Expansion

This submission builds upon Visby Medical’s prior successes, including their Sexual Health Test for women, which received FDA clearance for point-of-care use in March 2023. Furthermore, in March 2025, they introduced the first-ever Over the Counter (OTC) at-home PCR test for sexual health. As highlighted by Dr. Gary Schoolnik, Chief Medical Officer of Visby Medical, the introduction of the Men's Sexual Health Test integrates seamlessly into their existing product portfolio aimed at combating STIs, which affect roughly 20% of the population in the U.S., according to the CDC.

Addressing the Broader Healthcare Landscape

The need for fast, reliable diagnostic tools has never been more apparent, as the rise in STIs places significant strain on healthcare systems. The CDC's alarming statistics stress the importance of improving sexual health diagnostics not just for men, but for society as a whole. Dr. Schoolnik emphasizes the test’s potential to reduce barriers in the test-to-treat continuum, optimizing patient outcomes with the key reliability that Visby Medical is known for.

Future Innovations

Visby Medical is not stopping here. The company also obtained FDA clearance for its Respiratory Health Test, capable of detecting influenza A and B, as well as SARS-CoV-2 (COVID-19) in February 2025. This indicates a broader commitment to transforming infectious disease diagnostics by leveraging their core PCR technology.

With the launch of the Men's Sexual Health Test, Visby Medical continues to challenge the status quo in diagnostics. Founded in 2012, the company remains focused on empowering physicians and patients alike to test for infections quickly and accurately, thereby enhancing the quality of care available.

For more information, visit www.visby.com and check out their offerings for consumers and healthcare providers alike. The landscape of sexual health testing is changing, and Visby Medical is leading the charge towards a more informed and healthier future.