The U.S. Food and Drug Administration (FDA) has granted marketing authorization for the first at-home syphilis test.
NOWDiagnostics, Inc’s First To Know Syphilis Test provides an in-home result in 15 minutes with a single drop of blood. It has been proven in a clinical study of 1,270 people to be easy to use. The test received marketing authorization from the FDA through the de novo pathway, recognizing it as a novel device for syphilis testing in the United States, distinguishing it from other products on the market.
Syphilis has resurged at an alarming rate in the U.S. in nearly every demographic group and region, including newborns. Cases increased by 80% to more than 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, according to the federal Centers for Disease Control and Prevention (CDC). 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,” says Rob Weigle, CEO of NOWDx, in a news release. “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,” adds 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.”
The First To Know Syphilis Test is a patented buffer-less lateral flow device that provides a qualitative rapid membrane immunochromatographic assay for detecting Treponema pallidum (syphilis) antibodies in human whole blood from individuals suspected of having a syphilis infection. In a clinical study of 1,270 people, the NPA (negative percent agreement) was 99.5%, meaning it correctly identified 99.5% of negative specimens; the PPA (positive percent agreement) was 93.4%, meaning it correctly identified 93.4% of positive specimens when compared to three FDA cleared laboratory tests.
First To Know Syphilis Tests are expected to be available at major national retailers and online in the second half of 2024.
