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 syphilis epidemic.
“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 a diagnosis, which can result in increased treatment and reduction in the spread of infection," said Tarver.
The FDA says when syphilis goes untreated it can seriously damage the heart and brain and can even cause blindness, deafness and paralysis. If pregnant women contract syphilis, it can cause miscarriage or infant death and long-term medical consequences for the mother.
The FDA reminds people that the at-home test, if positive, is not sufficient to diagnose syphilis infection and should be followed by additional testing through a healthcare provider to confirm a diagnosis of syphilis.
The results of the test will be positive for individuals previously diagnosed with syphilis, even if they were successfully treated. At-home test results should not be used to start, stop or change any treatments without a health care provider.
The FDA reminds users that, as with many other tests, the risks associated with this test are mainly the possibility of false positive and false negative test results.
False negative test results can delay effective treatment and possibly cause the spread of infection to other persons throughout your community. False positive results could lead to additional unnecessary testing and delay a correct diagnosis.
The FDA reviewed this test under the De Novo premarket review pathway, a regulatory pathway for new low- to moderate-risk devices.
Along with this De Novo authorization, the FDA is establishing special controls for labeling and performance testing requirements. When met, the special controls, in combination with general controls, provide assurance of safety and effectiveness.
These authorization actions create new regulations, which means that other tests with the same intended use may go through the FDA’s 510(k) premarket process to obtain marketing authorization by demonstrating substantial equivalence to an existing test, saving developers time and expense.
