NOWDx Gets De Novo Nod for Rapid, OTC First To Know Syphilis Test

NOWDiagnostics has earned de novo clearance from the U.S. Food and Drug Administration (FDA) for over-the-counter (OTC) use of its First to Know syphilis test.
 
First To Know, according to the company, is the first, only rapid syphilis test in the U.S. that generates an in-home result in 15 minutes with one drop of blood. A clinical study of 1,270 people also proved the test easy to use.
 
The study’s NPA (negative percent agreement) was 99.5%, meaning it correctly identified 99.5% of negative specimens; the PPA (positive percent agreement) was 93.4%, meaning it correctly identified 93.4% of positive specimens when compared to three FDA cleared laboratory tests.
 
The FDA advised that results from this type of test alone aren’t sufficient to diagnose syphilis infection and should be followed by further testing to confirm diagnosis. Results of this test, according to the agency, will be positive for individuals previously diagnosed with syphilis, even if they were successfully treated.
 
The First To Know Syphilis Test is a patented, buffer-less lateral flow device that provides a qualitative rapid membrane immunochromatographic assay for detecting Treponema pallidum (syphilis) antibodies in human whole blood (capillary) from individuals suspected of having a syphilis infection.
 
“FDA granting De Novo authorization of our First To Know Syphilis Test could not have come at a more important juncture in our country’s efforts to slow the rise of syphilis,” said Rob Weigle, CEO of NOWDx. “Testing is one of the most important tools we have in preventing the spread of sexually transmitted infections, and for the first time ever, consumers now have a fast and simple syphilis test that can be performed in the privacy of one’s home, with a result in minutes.”