FDA Approves First At-Home Syphilis Blood Test

NBC News reports:

The Food and Drug Administration on Friday granted marketing authorization to the first at-home, over-the-counter test to detect syphilis antibodies in human blood in a move that could help boost screening rates for the sexually transmitted disease.

Developed by privately held NOWDiagnostics, the antibody test helps identify current or past infection and provides a result in about 15 minutes.

However, the regulator added that the results from the test alone are not sufficient for definitive diagnosis, and should be followed by additional testing to confirm a diagnosis.

Read the full article.

Today, we granted marketing authorization to NOWDiagnostics for the First To Know Syphilis Test. This is the first at-home, over-the-counter test to detect Treponema pallidum (syphilis) antibodies in human blood. https://t.co/dx59rKqmUa pic.twitter.com/nsKPZx6XmY

— U.S. FDA (@US_FDA) August 16, 2024