MedCity News August 18, 2024
Frank Vinluan

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...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

Continue Reading

 
Topics: FDA, Govt Agencies, Home, Patient / Consumer, Provider
Related Articles:
Opinion: Three former FDA officials: Here’s what Trump and his nominees need to know
Inflammatix Scores FDA Approval for Precision Infection Test
FDA Approves Spravato as Monotherapy for Major Depressive Disorder
A next-generation form of chemotherapy wins FDA approval
AstraZeneca, Daiichi’s Enhertu successor gets first FDA OK in breast cancer

Share This Article