Visby Medical™ Submits Men's Sexual Health Test to FDA for Clearance and CLIA Waiver

If cleared, Visby Medical's test will provide fast PCR results for Chlamydia and Gonorrhea using male urine samples in diverse clinical settings, meeting clinical demand and established medical guidelines at a time when STIs are a growing threat to public health and the nation's healthcare system.

SAN JOSE, Calif., May 27, 2025 /PRNewswire/ -- Visby Medical™, a leading innovator in medical diagnostics, has submitted its Visby Medical Men's Sexual Health Test to the U.S. Food and Drug Administration (FDA) for 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver. If cleared, the test will deliver Polymerase Chain Reaction (PCR) results in under 30 minutes for Chlamydia and Gonorrhea detection from male urine samples in symptomatic and asymptomatic men.

The Visby Medical Men's Sexual Health Test is a single-use, instrument-free Point of Care (POC) diagnostic requiring no capital investment, maintenance or refrigeration, which allows easy integration into diverse clinical settings including urgent care centers, community health clinics, and physician offices. It uses the same proven technology and workflow as the Visby Medical Sexual Health Test, which received 510(k) clearance and CLIA waiver for POC use in women in March, 2023, and the Visby Medical Women's Sexual Health Test, which became the first-ever Over the Counter (OTC) at-home PCR test for sexual health in March, 2025.

"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 (STI), which affect 20 percent of the U.S. population, according to the CDC,"  said Dr. Gary Schoolnik, Chief Medical Officer of Visby Medical. "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 clinical need because it streamlines the test-to-treat process with the PCR accuracy that Visby Medical is known for."

In addition to Sexual Health, Visby Medical also earned 510(k) clearance and CLIA waiver in February, 2025 for its Visby Medical Respiratory Health Test for influenza A & B, and SARS-CoV-2 (COVID-19). "Our core PCR technology continues to provide transformative solutions to some of today's greatest clinical challenges and complex health conditions by expediting accurate and efficient diagnosis for patients who need them most," said Dr. Schoolnik.

About Visby Medical™
Founded in 2012, Visby Medical is revolutionizing infectious disease diagnosis by empowering both physicians and patients to accurately test for infections anywhere, anytime, with laboratory accuracy. The company's proprietary technology platform delivers true PCR results in under 30 minutes through the world's first instrument-free, single-use PCR tests that fit in the palm of your hand. Currently, Visby Medical offers FDA-cleared tests for sexually transmitted infections (STIs), available both in point-of-care settings and now directly to consumers at home, and respiratory infections (COVID-19 and flu), available for point-of-care settings. Visby Medical is actively expanding its platform with a wide range of future tests for the at-home and point-of-care markets.

For more information, visit www.visby.com . Follow Visby Medical on LinkedIn.

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SOURCE Visby Medical