Until now, people who suspected they might have syphilis needed to visit a doctor for testing. However, the FDA has recently approved the first over-the-counter, at-home syphilis test.
Developed by the biotech company NOWDiagnostics, the test requires just a single drop of blood and delivers results in 15 minutes. The company has announced that the test will be available in the latter half of 2024, with an expected price of $29.98.
While the new test offers a convenient first step for those who think they might have syphilis, the FDA advises that a positive result should be followed up with a visit to a healthcare provider for confirmation and further testing.
Syphilis, once nearly eradicated in the 1990s, has seen a sharp resurgence in the U.S. over recent decades. According to the latest data from the CDC, syphilis cases surged by 80% between 2018 and 2022, with a particularly alarming rise among newborns.
In fact, cases in newborns were more than 10 times higher in 2022 compared to a decade earlier. Overall, the number of reported syphilis cases in 2022 exceeded 207,000, the highest since the 1950s.
The FDA granted authorisation for the new test after NOWDiagnostics provided data from clinical trials demonstrating that the First To Know Syphilis Test correctly identified a positive sample 93.4% of the time. The trials also showed that the test is user-friendly, even for those without medical training.
NOWDiagnostics hopes that their test will make a significant public health impact, particularly by improving access to early detection and treatment, especially in communities facing the ongoing rise in syphilis cases.
In a news release, Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health said: “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.
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.”
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