NEW YORK – The US Food and Drug Administration announced Friday that it has authorized an over-the-counter molecular test for chlamydia, gonorrhea, and trichomoniasis detection at home.
The Visby Medical Women’s Sexual Health Test is a 30-minute, single-use PCR test that can be purchased without a prescription and is intended for use by females with or without symptoms.
This is the first diagnostic test for chlamydia, gonorrhea, and trichomoniasis that can be purchased without a prescription and performed entirely at home, the FDA said in a statement.
Visby's point-of-care respiratory panel obtained clearance last month while its point-of-care CT/NG and Trich test was cleared by the FDA and CLIA waived in 2023.
The privacy afforded by home tests is particularly important for STIs, Courtney Lias, director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health, said.
"Patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment," Lias said, adding, "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."
There were 2.2 million cases of chlamydia and gonorrhea in the US in 2023, while trichomoniasis is estimated to be the most prevalent nonviral STI globally. In the US, it impacts roughly 2.6 million people. If left untreated, these infections can cause serious health complications for patients, including infertility.
The Visby test communicates securely to the Visby Medical App, which displays results when the test is complete. It correctly identifies 98.8 percent of negative and 97.2 percent of positive Chlamydia trachomatis samples, 99.1 percent of negative and 100 percent of positive Neisseria gonorrhoeae samples and 98.5 percent of negative and 97.8 percent of positive Trichomonas vaginalis samples.
"This approval is not just a milestone for Visby Medical but marks a transformative moment in medical diagnostics," said Adam de la Zerda, Visby's founder and CEO. The firm's palm-sized, single-use PCR test is simple to use and replaces a laboratory instrument, de la Zerda also said, adding that Visby built a "state-of-the-art, fully automated manufacturing line ready to rapidly scale production" in anticipation of consumer demand for its tests.
The FDA said it reviewed this test under its de novo premarket review pathway for low- to moderate-risk devices of a new type. Last year, the agency authorized the first at-home test for syphilis, and in 2023 it authorized the first diagnostic test for chlamydia and gonorrhea with home sample collection.