FDA Grants Marketing Authorization to First-Ever OTC Syphilis Test
First To Know Syphilis Tests are expected to be available at major national retailers and online in late 2024.
The FDA granted marketing authorization to NOWDiagnostics for its First To Know Syphilis Test, the first at-home, OTC test to detect Treponema pallidum (syphilis) antibodies in human blood.1 Requiring just a drop of blood, the rapid test delivers results in approximately 15 minutes and can help individuals make informed decisions about seeking further care for the sexually transmitted infection (STI).
3D illustration of syphilis pathogen / Christoph Burgstedt - stock.adobe.com
The authorization comes after review by the agency’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.1 A clinical trial involving 1270 participants demonstrated high accuracy and supported the authorization, as the test was able to identify 99.5% of negative syphilis cases and 93.4% of positive cases when compared to 3 FDA-cleared laboratory tests.2
Syphilis cases in the United States have surged 80% between 2018 and 2022, marking a continued upward trend over several decades, according to data from the CDC.3 The same data revealed that more than 3700 cases of congenital syphilis were documented among newborns in 2022, a tenfold increase compared to 2012.
Left untreated, syphilis can seriously damage the heart and cause blindness, deafness, and paralysis. When passed from mother to child during pregnancy, syphilis can lead to miscarriage, infant death, and lifelong health issues. However, the infection often shows few or no symptoms. The convenience of an at-home syphilis test enables individuals to easily screen themselves, facilitating timely diagnosis and care, as well as reducing the risk of transmission.
“FDA granting De Novo authorization of our First To Know Syphilis Test could not have come at a more important juncture in our country’s efforts to slow the rise of syphilis,” said Rob Weigle, chief executive officer of NOWDiagnostics, in a news release.2 “Testing is one of the most important tools we have in preventing the spread of sexually transmitted infections, and for the first time ever, consumers now have a fast and simple syphilis test that can be performed in the privacy of one’s home, with a result in minutes.”
READ MORE: First At-Home Test for Chlamydia, Gonorrhea Approved by FDA
The authorization of the test also aligns directly with the goals of the Department of Health and Human Services’ National Syphilis and Congenital Syphilis Syndemic Federal Task Force, established earlier this year to combat the rise in syphilis and congenital syphilis cases nationwide.1 Further, it supports the department’s broader STI National Strategic Plan aimed at reversing the surge in STIs across the United States.
Clearance of the First To Know Syphilis Test succeeds last year’s authorization of the first diagnostic test for chlamydia and gonorrhea with at-home sample collection. This landmark approval marked the first FDA-cleared at-home test for any STI other than HIV.1
“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, MD, PhD, acting director of the FDA’s Center for Devices and Radiological Health, in a news release.1 “Access to home tests may help increase initial screening for syphilis, including in individuals who may be reluctant to see their health care provider about possible sexually transmitted infection exposure. This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection."
First To Know Syphilis Tests are expected to be available at major national retailers and online in late 2024. It’s important to note that the test is not a diagnosis: results should be followed by additional testing with a health care provider, according to the FDA.1
READ MORE: Infectious Disease Resource Center
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