USFDA grants marketing authorization for First To Know Syphilis Test for OTC use

Syphilis has resurged at an alarming rate in the U.S. in nearly every demographic group and region, including newborns. According to the Centers for Disease Control and Prevention (CDC), cases increased by 80% to over 207,000 between 2018 and 2022. More than 3,700 cases of congenital syphilis were documented among newborns in 2022—10 times the number diagnosed in 2012. If untreated, syphilis can seriously damage the heart and brain and cause blindness, deafness, and paralysis. When transmitted during pregnancy, it can cause miscarriage, lifelong medical issues, and infant death. Often, those with syphilis do not notice symptoms.

“FDA granting De Novo authorization of our First To Know Syphilis Test could not have come at a more important juncture in our country’s efforts to slow the rise of syphilis,” said Rob Weigle, CEO of NOWDx. “Testing is one of the most important tools we have in preventing the spread of sexually transmitted infections, and for the first time ever, consumers now have a fast and simple syphilis test that can be performed in the privacy of one’s home, with a result in minutes.”

"This FDA authorization is a significant milestone in addressing the syphilis epidemic," said Dr. Gregory Bledsoe, MD, MPH, MBA, former Surgeon General for Arkansas. "After reviewing the robust data from the clinical studies, I am impressed with the test's performance. There is a critical need to increase public awareness about the seriousness of untreated syphilis, especially in underserved and marginalized populations. An in-home test like this has the potential to greatly impact public health by improving access to timely detection and treatment."