With cases rising, FDA authorizes first over-the-counter home syphilis test

The US Food and Drug Administration authorized the first at-home over-the-counter test for syphilis Friday.

Until now, people who suspected that they had the sexually transmitted infection had to go to a doctor to get tested. With the new test from the biotech company NOWDiagnostics, it will take the user just 15 minutes and a single drop of blood to determine whether they have syphilis.

However, this test is just a first step if someone suspects that they have the disease, the FDA says. If they test positive at home, they’re advised to go to a doctor for further testing to confirm the diagnosis.

The company said the test will be available in the second half of 2024 and is expected to cost $29.98.

“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 Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, in a news 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.”

Syphilis had been close to elimination in the 1990s, but the number of people testing positive in the United States has increased dramatically in the past few decades.

Cases increased 80% between 2018 and 2022, including among newborns, according to the latest data from the US Centers for Disease Control and Prevention. Cases in newborns alone were more than 10 times higher in 2022 than a decade before. In 2022, there were more than 207,000 total syphilis cases reported, the highest number since the 1950s, according to the CDC.

Syphilis is a bacterial infection that may appear minor at first. In the first stage, people may notice a sore on their genitals or anus. The sore typically can heal on its own, but treatment with antibiotics is still necessary to prevent the infection to becoming more serious. In its final stages, syphilis can cause blindness, deafness, brain and heart damage if left untreated. A pregnant person who gets an infection can miscarry or pass the infection to the infant and give birth to a child with lifelong medical issues.

The new test received FDA authorization after the company submitted data from clinical trials showing that the First To Know Syphilis Test identified a positive specimen 93.4% of the time. The trials also showed that it was easy for people without medical training to use the test.

NOWDiagnostics said it hopes its test will have a significant impact on public health and help improve access to timely detection and treatment, particularly with the surge in cases in underserved populations.