FDA Approves First At-Home Test for Syphilis

The US Food and Drug Administration (FDA) has approved the first at-home test for detecting syphilis antibodies. It allows individuals to screen themselves for sexually transmitted diseases. This test is from NOWDiagnostics and provides results in 15 minutes. But a positive result requires a medical professional visit. 

This test is expected to be available in 2024 and is expected to cost $29.98. 

Dr. Michelle Tarver said that these home tests can increase initial screening for syphilis and that can increase the chances of lab testing for diagnosis. This can help experts develop some new effective treatments that can help us reduce the risk of infection spread.  

Syphilis is a disease that was almost eliminated in the 1990s. But now more people in the United States are testing positive for it. 

The number of cases of syphilis increased by 80% between 2018 and 2022. It affected newborns, and the cases were over 10 times higher than a decade ago. In 2022, it affected 207,000 newborns and it was the highest since the 1950s. 

Syphilis is a mild bacterial infection that initially appears as a sore on the genitals or anus. It can heal on its own. But antibiotic treatment is necessary to prevent severe complications. It increases the risk of deafness, blindness, brain and heart damage. Hence, it needs more attention and proper treatment. Pregnant women can also miscarry or pass the infection to their infant and that can increase the risk of lifelong medical issues. 

The FDA approved the First to Know Syphilis Test when clinical trials showed its accuracy of 93.4% in predicting syphilis. The results of the trials also showed that this test is very easy to use for individuals without any medical training.