FDA announcements or official regulatory documents

FDA Approves NOWDiagnostics' First At-Home Syphilis Test

Aug 16, 2024, 04:04 PM

The U.S. Food and Drug Administration (FDA) has granted De Novo Marketing Authorization to NOWDiagnostics for the First To Know Syphilis Test, marking the first at-home, over-the-counter test to detect Treponema pallidum (syphilis) antibodies in human blood. The test, developed by NOWDiagnostics, delivers results in about 15 minutes and aims to increase screening rates for syphilis, a sexually transmitted disease. Despite its convenience, the FDA cautioned that the test alone is not sufficient for a complete diagnosis, and further medical consultation is recommended.