FDA has granted marketing authorization to “NOWDiagnostics for the First To Know Syphilis Test. This is the first at-home, over-the-counter test to detect Treponema pallidum (syphilis) antibodies in human blood.”
FDA stresses that “results from this type of test alone are not sufficient to diagnose syphilis infection and should be followed by additional testing to confirm a diagnosis of syphilis.”
Reported syphilis cases “increased 80% in the [U.S.] between 2018 and 2022 (from 115,000 to more than 207,000), continuing a decades-long upward trend.” This test provides users with the first over-the-counter test to inform about potential syphilis infection. Michelle Tarver, M.D., Ph.D., acting director of the FDA’s Center for Devices and Radiological Health, says that this home test may “help increase initial screening for syphilis, including in individuals who may be reluctant to see their healthcare provider about possible sexually transmitted infection exposure.”
Earlier this year, HHS “established the National Syphilis and Congenital Syphilis Syndemic (NSCSS) Federal Task Force” to respond to the recent dramatic rise of the diseases in the U.S. If left untreated, “syphilis can seriously damage the heart and brain and can cause blindness, deafness, and paralysis. When transmitted during pregnancy, it can cause miscarriage, lifelong medical issues, and infant death.”
Results of this new at-home test “should be followed by additional laboratory testing through a healthcare provider to confirm a diagnosis of syphilis.”
