US FDA grants marketing authorization for NOWDiagnostics' at-home syphilis antibody test.

The US FDA has granted marketing authorisation to NOWDiagnostics for the first at-home, over-the-counter test to detect syphilis antibodies in human blood. This marks a significant development in home health testing, allowing individuals to conveniently test for the sexually transmitted infection in the privacy of their own homes. While results from this test alone are not sufficient to diagnose syphilis infection, they can help inform the need for confirmatory testing. The FDA has established special controls to regulate this test, defining labeling and performance requirements, and this authorization creates a new regulatory classification that allows for a more streamlined process for future devices of the same type.

August 16, 2024
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