Labcorp to Offer First FDA-Cleared Blood Test to Detect Alzheimer's Disease Pathology in Both Primary and Specialty Care Settings

The Elecsys pTau-217 test measures phosphorylated Tau 217, a biomarker associated with amyloid pathology and Alzheimer’s disease. Labcorp said the test is FDA-cleared for use across specialty and primary care settings, distinguishing it from tests limited to narrower clinical environments.

The product connects Labcorp with Roche’s Elecsys diagnostic platform and with clinicians evaluating patients for possible Alzheimer’s disease. Its ability to rule in and rule out amyloid pathology could allow blood testing to serve as an earlier screening step before more specialized workups.

The announcement does not provide pricing, expected testing volumes, reimbursement details, launch timing beyond the offer, or a forecast for revenue contribution. Those details, along with physician adoption and payer coverage, are the next concrete markers for assessing the product’s financial impact.