NOWDiagnostics First To Know Syphilis Test gets US FDA De Novo marketing authorization for OTC use

NOWDiagnostics, Inc. (NOWDx) has received FDA authorization for its First To Know Syphilis Test, the first OTC rapid syphilis test in the US. This test provides results in 15 minutes from a single drop of blood and has been validated in a study of 1,270 participants. It is recognized as a novel device through the FDA’s de novo pathway.

Syphilis cases in the US have surged by 80% to over 207,000 between 2018 and 2022, with a tenfold increase in congenital syphilis cases since 2012. Untreated syphilis can cause severe health issues, including damage to the heart and brain, and risks during pregnancy.

The First To Know Test detects Treponema pallidum antibodies with 99.5% negative and 93.4% positive percent agreement compared to FDA-cleared lab tests. It is expected to be available at major retailers and online in late 2024. NOWDx specializes in rapid, accurate OTC and point-of-care diagnostic tests.