Visby Medical Wins De Novo Nod for OTC PCR Test for Women’s Sexual Health

Visby Medical has earned U.S. Food and Drug Administration (FDA) de novo authorization for its over-the-counter (OTC) Women’s Sexual Health Test. The test provides rapid, at-home testing for Chlamydia, Gonorrhea, and Trichomoniasis—the three most common curable sexually transmitted infections (STIs).

The test is touted as the first-ever PCR (polymerase chain reaction) diagnostic device approved by the FDA for OTC home use for any indication. Visby’s technology provides results directly to users within 30 minutes, instead of existing home-based STI tests that require mailing samples to a lab.

Clinical studies with over 2,000 lay users showed the test delivers accuracy comparable to traditional lab-based PCR machines, meaning healthcare providers can prescribe treatment based on its results. A companion app guides users through the testing process, including sample collection, test execution, and interpretation of results.

This de novo nod poises Visby for expansion into the at-home diagnostics market. The company has plans to introduce further OTC tests for respiratory infections, sore throat conditions, urinary tract infections, and other common illnesses.

“This approval is not just a milestone for Visby Medical but marks a transformative moment in medical diagnostics,” said Adam de la Zerda, PhD, Founder and CEO of Visby Medical. “We’ve achieved something incredible; our palm-sized, single-use PCR test is simple to use and replaces a bulky, large, expensive laboratory instrument. After 12 years of development, our device delivers rapid, reliable results directly into the hands of consumers, with unparalleled convenience and privacy. We also built a state-of-the-art, fully automated manufacturing line ready to rapidly scale production in anticipation of growing consumer demand.”

“The clinical significance of bringing a rapid, highly accurate PCR diagnostic test into the home environment cannot be overstated,” said Gary Schoolnik, MD, Chief Medical Officer of Visby Medical. “Extensive clinical studies validate that this test empowers women to quickly understand what steps to take next, giving them the privacy, control, and confidence to seek the care they need. Importantly, many patients infected with these STIs are non-symptomatic, yet they can still suffer serious long-term health consequences. Our test directly addresses this silent epidemic by enabling detection and treatment.”