FDA Marketing Authorization Enables Increased Access to First Step of Syphilis Diagnosis

Today, the U.S. Food and Drug Administration granted marketing authorization to NOWDiagnostics for the First To Know Syphilis Test. This is the first at-home, over-the-counter test to detect Treponema pallidum (syphilis) antibodies in human blood. Results from this type of test alone are not sufficient to diagnose syphilis infection and should be followed by additional testing to confirm a diagnosis of syphilis.  

According to the U.S. Centers for Disease Control and Prevention, reported syphilis cases increased 80% in the United States between 2018 and 2022 (from 115,000 to more than 207,000), continuing a decades-long upward trend.

Prior to today’s action, there was no over-the-counter test to inform a user about a potential syphilis infection. The test provides an at-home result without a prescription, in approximately 15 minutes, which individuals can use to better inform next steps with a health care provider.

“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, M.D., Ph.D., acting director of the FDA’s Center for Devices and Radiological Health. “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.”

In response to the surging number of syphilis and congenital syphilis cases nationwide, earlier this year, the Department of Health and Human Services established the National Syphilis and Congenital Syphilis Syndemic (NSCSS) Federal Task Force to utilize its agencies, expertise and stakeholder network to respond to the U.S. syphilis and congenital syphilis epidemic. The authorization of this test will directly contribute toward the goals of the department’s STI National Strategic Plan, which aims to reverse the recent dramatic rise of STIs in the United States.

If left untreated, syphilis can seriously damage the heart and brain and can cause blindness, deafness and paralysis. When transmitted during pregnancy, it can cause miscarriage, lifelong medical issues and infant death.

As noted above, positive test results from this test alone are not sufficient to diagnose syphilis infection and should be followed by additional laboratory testing through a health care provider to confirm a diagnosis of syphilis. Results of this test will be positive for individuals previously diagnosed with syphilis, even if they were successfully treated. Results of the test alone should not be used to start, stop or change any treatments without a health care provider. In addition, individuals using this test who may have been recently exposed to syphilis should seek care from a health care provider for treatment and evaluation regardless of this test’s results.

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 result in delays to effective treatment, progression to disseminated disease, and spread of infection to other persons throughout your community. False positive results could lead to additional unnecessary testing and delay in receiving a correct diagnosis.

The FDA reviewed this test under the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device, which may save a developer time and expense compared to other review pathways. 

This announcement 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.

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