Visby Medical Receives Landmark FDA De Novo Authorization for First-Ever OTC PCR Test for Sexual Health
SAN JOSE, Calif., March 28, 2025 /PRNewswire/ -- Today, Visby Medical™, a leading innovator in medical diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for the Visby Medical Women's Sexual Health Test for Over the Counter (OTC) use. This groundbreaking test enables reliable, rapid, and private at-home testing for Chlamydia, Gonorrhea, and Trichomoniasis—the three most common curable sexually transmitted infections (STIs).
The Visby Medical Women's Sexual Health Test represents a significant milestone as the first-ever PCR (polymerase chain reaction) diagnostic device approved by the FDA for OTC home use for any indication. Unlike existing home-based STI tests that require mailing samples to a lab, Visby's revolutionary technology provides results directly to users within 30 minutes, utilizing real PCR technology, which is recognized as the gold standard in diagnostic accuracy.
'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.'
Clinical studies involving over 2,000 lay users demonstrated that the Visby Medical Women's Sexual Health Test delivers accuracy comparable to traditional laboratory-based PCR machines, enabling healthcare providers to confidently prescribe treatment based on its results. An intuitive companion app guides users through the entire testing process, including sample collection, test execution and interpretation of results, while delivering a seamless connection to further care options.
'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.'
Sexually transmitted infections remain widespread in the United States. The U.S. Centers for Disease Control and Prevention estimates approximately 1.6 million new Chlamydia cases and more than 700,000 Gonorrhea cases reported annually. Trichomoniasis also affects millions of people annually in the United States, highlighting the urgent need for rapid and accurate diagnosis.
The granting of this De Novo marketing authorization positions Visby Medical for significant expansion into the at-home diagnostics market, with plans underway to introduce additional OTC tests addressing respiratory infections, sore throat conditions, urinary tract infections, and other common illnesses. 'This is just the beginning of our journey into reshaping healthcare through at-home diagnostics,' added Dr. de la Zerda. 'We will soon announce several strategic and commercial partnerships.'
FDA's official announcement can be accessed here.
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.
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