Labcorp, a global leader of innovative and comprehensive laboratory services, announced it has expanded its portfolio of sexually transmitted infection (STI) testing options to include the First to Know Syphilis Test, the first over-the-counter blood test granted market authorization by the US Food & Drug Administration (FDA) that can be performed by both physicians and patients.
Labcorp will serve as the exclusive distributor of the First to Know Syphilis Test to providers in healthcare settings nationwide, through an agreement with over-the-counter and point-of-care diagnostic test developer NOWDiagnostics (NOWDx). This new offering reflects Labcorp’s commitment to expanding provider and patient access to fast and reliable syphilis tests in an effort to help combat the syphilis epidemic.
U.S. syphilis cases have surged by 80% between 2018 and 2022 to more than 207,000 reported cases in 2022. According to the World Health Organization (WHO), most cases are asymptomatic or undiagnosed, which makes testing critical to diagnosis and treatment. If untreated, syphilis can seriously damage the heart and brain and cause blindness, deafness and paralysis.
“The recent rise in syphilis cases highlights a critical gap in testing and treatment across the country,” said Dr. Brian Caveney, Labcorp’s chief medical and scientific officer. “This test is another tool in a provider’s arsenal as they face this serious public health emergency. Our agreement with NOWDx reflects our commitment to providing healthcare providers and patients across the country with access to tests that deliver fast and reliable results that empower them to make informed decisions about their health.”
Labcorp will leverage its scale as one of the largest diagnostics laboratories in the world to facilitate widespread availability of the First to Know Syphilis Test, which provides a result in 15 minutes with as little as a single drop of blood collected through a fingerstick. Physicians can utilize the test in clinical settings or give it to a patient to conduct in the comfort of their own home. Labcorp plans to make the test available to providers by the end of 2024 and directly to patients through Labcorp OnDemand in 2025.
“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,” said Robert Weigle, CEO of NOWDx. “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.”
As the FDA has noted, 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.
Labcorp currently offers treponemal and non-treponemal assays recommended by the Centers for Disease Control and Prevention (CDC) for the screening and diagnosis of syphilis. The company has seen syphilis testing volume more than double over the past decade, exceeding 5.5 million tests annually.
