FDA gives green light to first at-home syphilis test as cases rise

The Food and Drug Administration (FDA) granted market authorization to the first at-home syphilis test amid a decades-long rise of cases in the U.S.

The test, which detects syphilis antibodies in human blood, provides a result within 15 minutes. 

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

“This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection.”

The Centers for Disease Control and Prevention (CDC) has reported an 80 percent increase in syphilis cases between 2021 and 2022. According to the World Health Organization, syphilis cases increased by more than a million globally among adults aged 19-45, with positive cases spiking in Africa and the Americas.

Syphilis, which is a curable sexually transmitted infection, can cause serious health problems if left untreated, including damage to the heart and brain that can cause paralysis and blindness.

The infection can also be spread from mother to child during pregnancy, which can lead to miscarriage, lifelong medical issues and infant death. 

Between 2016 and 2022, the CDC observed the number of cases in expecting mothers tripled in the U.S. The study prompted the American College of Obstetricians and Gynecologists to issue new guidance recommending pregnant individuals be screened for syphilis three times during pregnancy.

The new test alone is not enough to diagnose syphilis — the FDA advises that the test be followed by additional testing with a health care provider to confirm the diagnosis.