NOWDiagnostics’ Syphilis test receives FDA de novo marketing authorization for OTC use

NOWDiagnostics, a developer of over-the-counter (OTC) and point-of-care (POC) diagnostic tests, 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.

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 (capillary) from individuals suspected of having a syphilis infection. ‘First To Know’ Syphilis Tests are expected to be available at major national retailers and online in the second half of 2024.