On Friday, the U.S. Food and Drug Administration granted NOWDiagnostics marketing authorization for the first at-home and over-the-counter syphilis test.
The First To Know Syphilis Test is designed to detect syphilis antibodies in human blood within 15 minutes.
“We continue to see advancements in tests, particularly tests for sexually transmitted infections, which can give patients more information about their health from the privacy of their own home,” said Michelle Tarver, M.D., Ph.D., acting director of the FDA’s Center for Devices and Radiological Health. “Access to home tests may help increase initial screening for syphilis, including in individuals who may be reluctant to see their health care provider about possible sexually transmitted infection exposure.
According to NOWDiagnostics, syphilis has risen in every age category and region, that includes newborns.
“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.”
The test joins other sexually transmitted infection tests approved for the diagnosis of chlamydia and gonorrhea.
The FDA recommends conducting additional tests to confirm a syphilis diagnosis, and the results from the OTC test alone should not be considered sufficient.
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