Labcorp Launches First FDA-Cleared Blood Test for Alzheimer's Disease Assessment in Primary Care

Core Insights - Labcorp has launched the Elecsys® pTau-181 test, the first FDA-cleared blood test for Alzheimer's disease assessment in primary care settings, now available nationwide for patients aged 55 and older experiencing cognitive decline [1] Group 1: Product Launch and Features - The Elecsys pTau-181 test aids clinicians in ruling out Alzheimer's disease by identifying patients unlikely to have amyloid pathology, allowing for timely evaluation of other cognitive decline causes [1] - The test offers a 97.9% negative predictive value, enhancing clinicians' confidence in ruling out Alzheimer's pathology in symptomatic patients [1] - Developed by Roche Diagnostics, the test was cleared by the FDA in 2025 and is performed via a simple blood draw, making it accessible in doctor's offices or Labcorp's over 2,200 patient service centers nationwide [1] Group 2: Market Context and Commitment - With an estimated 7.2 million Americans living with Alzheimer's disease, Labcorp is focused on expanding access to blood-based biomarkers for earlier assessment and diagnosis [1] - The launch of the Elecsys pTau-181 test strengthens Labcorp's portfolio of blood-based biomarker tests for Alzheimer's disease and other forms of dementia [1] - Labcorp has supported over 90 Alzheimer's disease protocols across more than 45 countries in the last five years, showcasing its deep expertise in Alzheimer's biomarkers and commitment to innovative testing [1]