MedCity News August 18, 2024
NOWDiagnostics’ First to Know has FDA De Novo marketing authorization as a new test for syphilis. The at-home product needs only a single drop of blood to test for this sexually transmitted infection.
Syphilis testing typically requires obtaining a blood sample and sending it to a lab. The wait for results ranges from hours to days. The FDA has authorized a new at-home syphilis test, a NOWDiagnostics product that yields results within 15 minutes.
The FDA said Friday that its marketing authorization for the NOWDiagnostics test makes the kit the first at-home, over-the-counter test for syphilis. Springdale, Arkansas-based NOWDiagnostics, or NOWDx, will market its new syphilis test as First-to-Know.
Syphilis is caused by a bacterium, Treponema pallidum. It’s treatable with...
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