The U.S. Food and Drug Administration has granted marketing authorization to NOWDiagnostics for the First To Know Syphilis Test, the first over-the-counter test for detecting syphilis antibodies. The test allows individuals to receive results in about 15 minutes, potentially increasing early screening for syphilis. 

Reported syphilis cases have increased by 80% between 2018 and 2022, continuing an upward trend, according to the Centers for Disease Control and Prevention.

“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," noted Michele Tarver, MD, acting director of the FDA's Center for Devices and Radiological Health.

The full approval information is available here.