FDA approves at-home chlamydia, gonorrhea, trichomoniasis test for women
Visby Medical Women's Sexual Health Test can be taken by those with or without symptoms,and delivers results in about 30 minutes, the FDA said in a news release.
This is the first diagnostic test for chlamydia, gonorrhea and trichomoniasis that can be bought without a prescription and done entirely at home. Last year, the FDA also authorized an at-home syphilis test.
'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 Office of In Vitro Diagnostic Devices in the FDA's Center for Devices and Radiological Health, said in a statement. '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.'
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The Visby Medical Women's Sexual Health Test, according to the FDA, correctly identified 98.8% of negative and 97.2% of positive Chlamydia trachomatis samples; 99.1% of negative and 100% of positive Neisseria gonorrhoeae samples; and 98.5% of negative and 97.8% of positive Trichomonas vaginalis samples, according to the FDA.
Adam de la Zerda, the founder and CEO of Visby Medical, said the test was in development for 12 years.
'This approval is not just a milestone for Visby Medical but marks a transformative moment in medical diagnostics,' de la Zerda 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.'
The test is single-use and includes a collection kit and powered testing device. Once the test is complete, results are shown on the Visby Medical App.
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.
More than 600,000 cases of gonorrhea and over 1.6 million cases of chlamydia were reported in the U.S. in 2023, the Centers for Disease Control and Prevention's Sexually Transmitted Infections (STI) Surveillance Report states. Trichomoniasis affected about 2.6 million people in 2021, per the CDC.
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