NOWDiagnostics First To Know® Syphilis Test Receives FDA De Novo Marketing Authorization for Over-the-Counter Use

SPRINGDALE, Ark.--(BUSINESS WIRE)--Aug 16, 2024-- NOWDiagnostics, Inc. ( NOWDx ), a developer of over-the-counter (OTC) and point-of-care (POC) diagnostic tests, today announced that the U.

S. Food and Drug Administration (FDA) has granted marketing authorization to its First To Know ® Syphilis Test for OTC use. First To Know ® is the first and only rapid syphilis test in the U.

S. that 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. This press release features multimedia. View the full release here: https://www.

businesswire.com/news/home/20240816394389/en/ First To Know® Syphilis Test (Photo: NOWDx) 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 .