NOWDiagnostics, Inc. (NOWDx), a developer of over-the-counter (OTC) and point-of-care (POC) diagnostic tests, today announced that Labcorp, a global leader of innovative and comprehensive laboratory services, will be the exclusive U.S. distributor of its First To Know Syphilis Test in professional and healthcare settings. Through Labcorp’s extensive distribution network and trusted presence in clinical settings, this collaboration will expand access to the syphilis test that provides results in 15 minutes with as little as a drop of blood. Labcorp plans to offer the test to professionals and hospital settings by the end of 2024 and directly to patients through Labcorp OnDemand in 2025.
“Our collaboration with Labcorp marks a pivotal moment for NOWDx as we scale up access to our First To Know Syphilis Test across the U.S.,” said Rob Weigle, CEO of NOWDx. “Labcorp’s confidence in our patented touch-to-test technology, along with their longstanding relationships in professional and hospital settings, ensures this critical diagnostic tool is available to more clinicians. Our retail and public health efforts, which will be announced shortly, alongside Labcorp’s initiatives in the professional and hospital settings, will increase access to testing. This will help support earlier detection and treatment as we address the concerning rise in syphilis cases by providing high-quality, easy-to-use diagnostics.”
Syphilis cases in the U.S. have increased by 80% since 2018, affecting over 207,000 people, including more than 3,700 newborns in 2022. As one of the fastest-growing sexually transmitted infections (STIs) in the U.S., syphilis can cause severe complications if untreated, including blindness, paralysis, and organ damage. When transmitted during pregnancy, it can lead to miscarriage or infant death. Often, those with syphilis do not notice symptoms.
“NOWDx’s innovative testing technology is a valuable addition to our syphilis portfolio, and we are pleased to work with them to expand access to the First To Know® Syphilis Test,” said Dr. Brian Caveney, Chief Medical and Scientific Officer at Labcorp. “With syphilis cases rising nationwide, we see a pressing need for accessible testing solutions that empower providers and patients on the path to treatment.”
This collaboration underscores Labcorp and NOWDx’s shared commitment to providing better diagnostic options and improving health outcomes nationwide. Labcorp will also be the U.S. distribution partner for the ADEXUSDx® hCG test currently utilized in hospital settings.
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. First to Know® received marketing authorization from the FDA through the de novo pathway recognizing it as a novel device for syphilis testing in the United States, distinguishing it from other products on the market. In a clinical study of 1,270 people, the 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. Results from the First to Know® Syphilis Test alone are not sufficient to diagnose syphilis infection and should be followed by additional testing to confirm a diagnosis of syphilis.
