FDA de novo authorisation for first-ever OTC PCR test for women’s sexual health

Diagnostics company Visby Medical has been granted De Novo authorisation for the Visby Medical Women’s Sexual Health Test by the U.S. Food and Drug Administration (FDA) for Over the Counter (OTC) use.

The groundbreaking test enables 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 is the first-ever PCR (polymerase chain reaction) diagnostic device approved by the FDA for OTC home use for any indication.

While existing home-based STI tests require mailing samples to a lab, Visby’s technology provides results directly to users within 30 minutes, utilising real PCR technology, which is recognised 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, 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, 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.”

Visby Medical now has further plans 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.”