Labcorp 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 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).
Labcorp will use 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.
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.
