FDA Approves First At-Home Syphilis Test Amid Rising Cases

The U.S. Food and Drug Administration (FDA) has granted authorization for NOWDiagnostic to market the first at-home, over-the-counter test for syphilis, responding to a concerning increase in syphilis cases across the United States. Syphilis, a sexually transmitted infection, poses significant health risks if untreated, including severe complications such as heart and brain damage, blindness, and paralysis. The infection can also be transmitted during pregnancy, leading to serious outcomes like miscarriage and lifelong health issues for infants. While the FDA emphasizes that the test results are not definitive for diagnosing syphilis, they can serve as a preliminary screening tool. The agency warns that the test carries risks of false positives and false negatives, which could delay necessary treatment and allow the infection to spread. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, noted that this test could be particularly beneficial for individuals hesitant to seek medical care regarding potential exposure to sexually transmitted infections. Globally, the World Health Organization (WHO) reported a significant rise in syphilis cases, with over a million new infections among individuals aged 15 to 49 in 2022, totaling 8 million cases. The Americas and Africa experienced the most substantial increases. WHO Director-General Tedros Adhanom Ghebreyesus expressed major concerns over the rising numbers, which contributed to an estimated 150,000 early fetal deaths and stillbirths, as well as 115,000 infants diagnosed with congenital syphilis last year.