Springdale Company Receives FDA Approval for At-Home Syphilis Test
Recently, a significant milestone was achieved in the fight against syphilis. NOWDiagnostics, a company based in Springdale, received FDA approval to market its First To Know Syphilis Test, the first at-home, over-the-counter test to detect syphilis. This test provides users with a fast and private way to check for the infection, contributing to the efforts to combat the surging syphilis and congenital syphilis epidemic in the United States.
The effectiveness of the test was demonstrated in a clinical study involving 1,270 people. It showed a 99.5% accuracy in identifying negative specimens and a 93.4% accuracy in identifying positive specimens compared to traditional laboratory tests. This approval opens the door for increased accessibility to syphilis testing, particularly for those who may be hesitant to seek medical help due to privacy concerns.
The syphilis epidemic in the U.S. has seen an alarming 80% increase from 2018 to 2022, affecting nearly every demographic group and region. There were more than 207,000 reported cases in 2022, a stark contrast to the 115,000 reported in 2018. Furthermore, congenital syphilis, a condition that can cause severe long-term health issues in newborns, has seen a tenfold increase between 2012 and 2022.
The First To Know Syphilis Test is expected to be available at major national retailers and online in the second half of 2024. This innovation is significant, as it provides individuals with a simple and quick way to initiate the process of diagnosis and treatment under the guidance of a healthcare provider.
