FDA authorizes first ever at-home syphilis test

SPOKANE, Wash. — On August 16, the U.S.

Food and Drug Administration (FDA) approved NOWDiagnostics to begin marketing the first at-home, over-the-counter syphilis test. While the at-home test alone is not sufficient to diagnose syphilis and should be followed by additional testing, the at-home test provides users with information that can then be taken to healthcare providers. “We continue to see advancements in tests, particularly tests for sexually transmitted infections, which can give patients more information about their health from the privacy of their own home,” said Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health.

The U.S. Centers for Disease Control and Prevention (CDC) reports that syphilis cases have increased in the United States by 80% between 2018 and 2022.

The FDA says the authorization of this at-home test will directly contribute to the STI National Strategic Plan , which aims to reverse the recent rise of STIs in the United States. This test follows last year’s authorization of the first diagnostic test for chlamydia and gonorrhea with at-home sample collection, which was the first FDA-authorized test with at-home sample collection for any sexually transmitted infection other than HIV. Additionally, the Department of Health and Human Services established the National Syphilis and Congenital Syphilis Syndemic (NSCSS) Federal Task Force early in 2024 to use federal agencies and expertise to respond to the syph.