NowDiagnostics has been granted de novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its First To Know over-the-counter (OTC) syphilis test.
The First To Know Syphilis Test is the first at-home, OTC test to detect Treponema pallidum (syphilis) antibodies in human blood, according to the FDA. The agency cautions that results from this test alone should be followed by additional testing to confirm the diagnosis of syphilis.
The test is a lateral flow device that provides a qualitative rapid membrane immunochromatographic assay for detecting T. pallidum antibodies in whole blood from individuals suspected of having a syphilis infection, NowDiagnostics said in a statement.
"FDA granting de novo authorization of our First To KnowSyphilis Test could not have come at a more important juncture in our country’s efforts to slow the rise of syphilis," Rob Weigle, CEO of NowDiagnostics, said.
"Testing is one of the most important tools we have in preventing the spread of sexually transmitted infections, and for the first time, 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."
According to the U.S. Centers for Disease Control and Prevention, reported cases of syphilis have increased 80% from 115,000 to more than 207,000 from 2018 to 2022 as part of a decades-long upward trend. More than 3,700 cases of congenital syphilis, which may cause lifelong medical issues, were documented among newborns in 2022, a tenfold increase in the number of cases since 2012. Syphilis, which may be asymptomatic, can cause heart and brain damage if left untreated, as well as blindness, deafness, and paralysis.
The First To Know Syphilis Test is expected to be available at major national retailers and online in the second half of 2024. For more information about the test and its availability, visit www.firsttoknow.com.
