On Mar. 28, 2025, Visby Medical™ 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.

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.

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.