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Labcorp Launches FDA-Cleared Blood Test for Alzheimer’s Pathology

Patients aged 55 and older showing signs of cognitive decline now have access to a standardized diagnostic tool designed to detect amyloid pathology. Labcorp is rolling out the Elecsys pTau-217 blood test nationwide, marking the first FDA-cleared, single-biomarker assay capable of ruling out Alzheimer’s indicators across both primary and specialty care settings.

Labcorp Launches FDA-Cleared Blood Test for Alzheimer’s Pathology
Photo: Bio & News

For many, the path to an Alzheimer’s diagnosis is often fragmented, requiring multiple specialists and invasive procedures. By measuring the pTau-217 biomarker, this blood test offers a minimally invasive alternative that matches the performance of traditional cerebrospinal fluid analysis and PET imaging. The test provides clinicians with positive, intermediate, or negative result categories, streamlining the diagnostic workflow regardless of whether the patient is in a general practitioner’s office or a specialized neurology clinic.

Dr. Brian Caveney, chief medical and scientific officer at Labcorp, noted that the goal is to make the diagnostic process more accessible and consistent for families facing the uncertainty of cognitive changes. Once a physician orders the test, patients can complete the blood draw at any of Labcorp’s 2,200 service centers. This addition to the company’s portfolio complements existing offerings, such as the pTau-181 test, and aims to provide earlier, more informed clinical decision-making for neurodegenerative conditions.

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