NOWDiagnostics First To Know® Syphilis Test Receives FDA De Novo Marketing Authorization

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.