The FDA has granted marketing authorization to Visby Medical for the Visby Medical Women's Sexual Health Test. This is the first diagnostic test for chlamydia, gonorrhea and trichomoniasis that can be purchased without a prescription and performed entirely at home. The test is intended for females with or without symptoms and delivers results in approximately 30 minutes.
"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," said Courtney Lias, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA's Center for Devices and Radiological Health. "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."
The Visby Medical Women's Sexual Health Test is a single use, at home test, that includes a collection kit (self-collected vaginal swab) and a powered testing device, which communicates securely to the Visby Medical App, which displays results when the test is complete.
Individuals with positive results for any of the three infections should seek medical care. Individuals with symptoms, recent exposure to an STI or other concerns despite a negative result should contact their health care provider for additional testing.
