WASHINGTON, D.C. — The U.S. Food and Drug Administration announced on August 16 that it has granted marketing authorization to NOWDiagnostics for the First To Know Syphilis Test, marking the first over-the-counter, at-home test to detect Treponema pallidum (syphilis) antibodies in human blood.
While the test offers users a way to check for syphilis antibodies at home, the FDA emphasized that a positive result from this test alone is not sufficient for a definitive diagnosis of syphilis. Additional laboratory testing is necessary to confirm the infection, according to the agency.
The authorization comes at a critical time, as syphilis cases in the United States have surged by 80% between 2018 and 2022, increasing from 115,000 to over 207,000 reported cases, according to data from the U.S. Centers for Disease Control and Prevention (CDC). This rise continues a decades-long upward trend, highlighting the growing public health concern.
“Advancements in at-home tests, particularly for sexually transmitted infections, are crucial in giving patients more information about their health privately,” said Michelle Tarver, M.D., Ph.D., acting director of the FDA’s Center for Devices and Radiological Health. “Access to home tests like this one may encourage more individuals to undergo initial screening for syphilis, leading to increased lab testing and, ultimately, more effective treatment and reduced transmission.”
Prior to this authorization, no over-the-counter test was available to alert individuals to a potential syphilis infection. The new test provides results in approximately 15 minutes without requiring a prescription, allowing individuals to make informed decisions about seeking further medical evaluation.
In response to the rising number of syphilis and congenital syphilis cases, the Department of Health and Human Services earlier this year established the National Syphilis and Congenital Syphilis Syndemic (NSCSS) Federal Task Force. This initiative aims to utilize federal resources and expertise to combat the syphilis epidemic. The authorization of this at-home test aligns with the goals of the department’s STI National Strategic Plan, which seeks to reverse the increasing rates of sexually transmitted infections in the U.S.
Syphilis, if left untreated, can cause severe complications, including damage to the heart and brain, blindness, deafness, and paralysis. When transmitted during pregnancy, it can lead to miscarriage, infant death, or lifelong medical issues for the child.
The FDA reviewed the First To Know Syphilis Test under its De Novo premarket review pathway, a regulatory process for low- to moderate-risk devices that are of a new type. The FDA is also establishing special controls related to labeling and performance testing, which, when met, provide reasonable assurance of the test’s safety and effectiveness. This regulatory action paves the way for future devices of the same type to gain marketing authorization through a streamlined process, potentially reducing time and expense for developers.
The announcement follows last year’s FDA authorization of the first diagnostic test for chlamydia and gonorrhea with at-home sample collection, which was the first such test for any sexually transmitted infection other than HIV.
