The First to Know test for syphilis, manufactured by NOWDiagnostics, is the first at-home, over-the-counter test for the sexually transmitted disease to be approved by the Food and Drug Administration. Photo courtesy NOWDiagnostics
The Food and Drug Administration on Friday approved the first over-the-counter, at-home test for syphilis in response to surging levels of the sexually transmitted disease nationwide.
Regulators issued the green light for the release of the First To Know Syphilis Test, made by NOWDiagnostics of Springdale, Ariz., noting its status as the first at-home test to detect Treponema pallidum, or syphilis, antibodies in human blood. Advertisement
They cautioned that results from the home test alone are not sufficient to accurately diagnose a syphilis infection and should be followed by additional testing by medical professionals.
Even so, the approval marks a significant milestone in the detection and treatment of STDs as cases soar across the United States, health officials said.
“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,” said Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health. “This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection.” Advertisement
Syphilis can seriously damage the heart and brain and can cause blindness, deafness and paralysis if left untreated, and when transmitted during pregnancy, can cause miscarriage, lifelong medical issues and infant death.
It’s one of most serious of the sexually transmitted diseases and is now seeing a major resurgence. The U.S. Centers for Disease Control and Prevention reported syphilis cases increased 80% between 2018 and 2022, jumping from 115,000 to more than 207,000, reaching their highest levels since the 1950s.
The situation has become so concerning that the Department of Health and Human Services in January established the National Syphilis and Congenital Syphilis Syndemic Federal Task Force to tackle the problem.
“The syphilis crisis in our country is unacceptable,” said HHS Secretary Xavier Becerra. “The Biden-Harris Administration is committed to addressing this urgent issue and using all available means to eliminate disparities in our health care system.”
