First At-Home, OTC Syphilis Test Granted Marketing Authorization by FDA

The FDA has granted marketing authorization to NOWDiagnostics for the first at-home, over-the-counter antibody test to detect a potential syphilis infection, according to an agency press release. This is a crucial development in combatting the rise in syphilis cases in the US, which increased 80% between 2018 and 2022, after decades of upward climb, according to the latest estimates from the CDC.

The First to Know Syphilis Test detects a current or past infection, regardless of successful treatment, in 15 minutes using a drop of blood. Individuals with a positive result should seek further testing through a health care professional for confirmation of the infection because the test is “not sufficient to diagnose syphilis infection” by itself, the FDA said in the August 16, 2024, press release.

The main risks associated with the test are the possibility of false positive and false negative results. Results of the First to Know Syphilis Test will be positive for persons who have previously been diagnosed with syphilis, even if they were successfully treated. Also, results of this test should not be used to start, stop, or change any current treatments with a clinician. Individuals who use the test who may have been recently exposed to syphilis should seek treatment and evaluation regardless of their results, according to the FDA.

“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,” Michelle Tarver, MD, PhD, acting director of the FDA’s Center for Devices and Radiological Health, said in the release. “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 addition to the 80% increase in syphilis cases, in 2022 alone, there were 3755 reported cases of congenital syphilis, which reflected a 937% increase in the past decade, according to the CDC. In response to the increase in cases of both syphilis and congenital syphilis, the Department of Health and Human Services (DHHS) established the National Syphilis and Congenital Syphilis Syndemic Federal Task Force earlier this year. The marketing authorization of the First to Know Syphilis Test will directly contribute to the goals of the DHHS’ STI National Strategic Plan, which is a novel 5-year plan to reverse the recent rise in syphilis and other sexually transmitted infections (STIs) in the US.

The agency reviewed the test under its De Novo premarket review pathway, which allows classification of novel low- to moderate-risk medical devices for which general or general and special controls provide reasonable confidence of safety and effectiveness for use but for which no predicate device is legally marketed. The De Novo review pathway creates a new regulatory classification meaning that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, the agency noted.

This announcement follows last year’s FDA authorization of a diagnostic test for chlamydia and gonorrhea with at-home sample collection, which was the first of its kind for any STI other than HIV, according to the press release.

Reference: FDA marketing authorization enables increased access to first step of syphilis diagnosis. News item. US Food and Drug Administration. August 16, 2024. Accessed August 19, 2024. https://www.fda.gov/news-events/press-announcements/fda-marketing-authorization-enables-increased-access-first-step-syphilis-diagnosis