First Over-the-Counter Syphilis Test Approved By FDA

The U.S. Food and Drug Administration (FDA) has approved the first at-home over-the-counter syphilis test.

The new test comes from the biotech company NOWDiagnostics. It will take the user just 15 minutes with a single drop of blood to determine if they have syphilis.

The test is just the first step if someone believes they have the disease. If a person tests positive at home, they’re urged to go to the doctor to confirm the results.

NowDiagnostics said the test will be available in the coming months and is expected to cost just under $30.

“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 is a bacterial infection that could be minor at first. Sores found on the genitals or anus can heal on its own, but treatment with antibiotics is necessary to stop the spread of the STI. Severe syphilis cases can cause blindness, deafness and brain and heart damage. 

The disease had been close to elimination in the 1990s, but the number of people testing positive in the U.S. increased dramatically in the past few decades. Cases increased 80% between 2018 and 2022 according to the Centers for Disease Control and Prevention. There were 207,000 total syphilis cases reported in 2022, the highest number since the 1950s.

The FDA approved the new test after the company reported data from clinical trials showing the First to Know Syphilis Test worked 93.4% of the time. The trials also showed it was easy to use the test without medical training.

NowDiagnostics said it hopes the test will have a significant impact on public health and help underserved populations know their status.

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