The FDA has cleared its first completely at-home sexual health test for women, available over-the-counter to screen for chlamydia, gonorrhea and trichomoniasis.
The single-use kit from Visby Medical includes vaginal swabs and a palm-sized, PCR-based testing device, designed to deliver a result to the user’s smartphone within 30 minutes. The company previously acquired an agency green light for a point-of-care version of the test used by healthcare professionals.
The new de novo clearance also follows up on its first regulatory OK last August for an at-home syphilis test, developed by NOWDiagnostics, as the FDA continues to expand its authorizations for self-collected samples in sexually transmitted infections outside of HIV.
“Home tests can give people information about their health from the privacy of their home. This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment,” Courtney Lias, Ph.D., director of the FDA’s Office of In Vitro Diagnostic Devices, said in a statement.
According to statistics from the Centers for Disease Control and Prevention, diagnoses of chlamydia and gonorrhea reached 2.2 million in 2023—while trichomoniasis is estimated to be the most prevalent nonviral sexually transmitted infection globally, with 2.6 million cases in the U.S. alone.
All three—considered the most common STIs—can be addressed with antibiotics but can cause serious complications if left untreated.
“Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection,” Lias said.
Visby said clinical studies involving more than 2,000 users showed the test’s accuracy to be on par with traditional, laboratory-based PCR machines.
“This approval is not just a milestone for Visby Medical but marks a transformative moment in medical diagnostics,” founder and CEO Adam de la Zerda, Ph.D., said in a statement. “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.”
Last month, Visby also acquired a 510(k) clearance from the FDA for its point-of-care respiratory disease test, designed to catch influenza A and B as well as the coronavirus behind COVID-19. That PCR test previously received an emergency authorization during the pandemic.
Visby previously raised $135 million in two tranches across 2022, with plans to help transition the San Jose, California-based startup away from COVID-19 and expand its menu of home-based and point-of-care tests.
Now, the company said it plans to use the de novo clearance to open the door to other over-the-counter tests in coughs, colds and sore throats as well as urinary tract infections and other illnesses.
“This is just the beginning of our journey into reshaping healthcare through at-home diagnostics,” said de la Zerda. “We will soon announce several strategic and commercial partnerships.”