The story has been corrected to state that Labcorp is the exclusive distributor for the test in US healthcare settings.
NEW YORK – Laboratory Corporation of America said Thursday that it has signed an agreement with NowDiagnostics (NowDx) to serve as the exclusive US distributor in healthcare settings for its First to Know Syphilis Test.
The First to Know test received US Food and Drug Administration authorization in August, making it the first over-the-counter syphilis test to be authorized by the agency.
The First To Know test detects antibodies against Treponema pallidum, the pathogen that causes syphilis, in finger-prick blood samples. While a positive antibody test is not sufficient to diagnose a current syphilis infection, the 15-minute test can inform patients of current or past infection and lead to confirmatory testing with a healthcare provider.
Labcorp said the test will be available to healthcare providers by the end of 2024 and will become available directly to patients through Labcorp OnDemand in 2025.
"The recent rise in syphilis cases highlights a critical gap in testing and treatment across the country," Brian Caveney, Labcorp's chief medical and scientific officer, said in a statement. "This test is another tool in a provider's arsenal as they face this serious public health emergency."
US syphilis cases jumped by 80 percent between 2018 and 2022 with more than 207,000 cases reported in 2022.
"Labcorp's strong infrastructure and commitment to advancing diagnostic technology and making testing widely accessible make it the ideal partner to help expand access to our tests and tackle critical public health issues, such as the rise in syphilis cases," NowDX CEO Robert Weigle said in a statement. "Together, we aim to ensure our cutting-edge, user-friendly tests are within reach for more patients and healthcare providers, ultimately enhancing early identification and treatment outcomes."
Labcorp also offers treponemal and non-treponemal assays for the screening and diagnosis of syphilis. Over the past decade, the company's syphilis testing volume has more than doubled and now exceeds 5.5 million tests annually.