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

• Elecsys® pTau-181 test helps clinicians rule out Alzheimer's disease by identifying patients unlikely to have amyloid pathology
• Now available nationwide in primary care settings for patients aged 55 and older experiencing symptoms of cognitive decline
• Expands Labcorp's comprehensive portfolio of Alzheimer's disease blood tests across both primary and specialty care settings

BURLINGTON, N.C., Feb. 11, 2026 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the nationwide availability of the Elecsys® pTau-181 test, the first and only blood test cleared by the U.S. Food and Drug Administration (FDA) to aid in the initial assessment of Alzheimer's disease in the primary care setting. This launch further expands Labcorp's comprehensive portfolio of Alzheimer's disease blood tests, offering clinicians solutions across both primary and specialty care settings.

"Primary care clinicians are often the first point of contact for patients with concerns related to cognitive symptoms, yet Alzheimer's testing has historically required a visit to a specialist," said Dr. Brian Caveney, chief medical and scientific officer at Labcorp. "By making this first-of-its-kind blood test available nationwide, Labcorp is giving primary care clinicians a powerful tool to help patients get answers sooner and guide next steps with confidence."

The Elecsys pTau-181 test helps clinicians rule out Alzheimer's disease by identifying which symptomatic patients aged 55 and older are unlikely to have amyloid pathology—abnormal protein buildup in the brain associated with Alzheimer's disease—in the context of all clinical findings. Patients with negative results can be evaluated for other potential causes of cognitive decline, while patients with positive results can be referred for additional testing. The test was developed by Roche Diagnostics and cleared by the FDA in 2025.

Key Benefits of the Elecsys pTau-181 Test:

• Offers 97.9% negative predictive value, helping clinicians more confidently rule out Alzheimer's pathology in symptomatic patients
• Is performed via a simple blood draw, which can be completed in a doctor's office or at any of Labcorp's more than 2,200 patient service centers nationwide
• Provides an alternative to traditional approaches that require brain scans or lumbar punctures, which can be costly, invasive or difficult to access
• Helps reduce unnecessary referrals amid a national shortage of neurologists, supporting timely evaluation of other causes of cognitive decline

Labcorp's Commitment to Innovative Alzheimer's Testing
With an estimated 7.2 million Americans living with Alzheimer's disease, Labcorp is committed to expanding access to blood-based biomarkers that support earlier assessment and diagnosis. The Elecsys pTau-181 test strengthens Labcorp's portfolio of blood-based biomarker tests for Alzheimer's disease and other forms of dementia. To learn more, visit: https://www.labcorp.com/treatment-areas/neurology

Labcorp's deep expertise in Alzheimer's biomarkers extends into therapeutic development, supporting more than 90 Alzheimer's disease protocols across more than 45 countries over the last five years. To learn more, visit: https://www.labcorp.com/treatment-areas/neurology/biomarker-development

About Labcorp
Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's nearly 70,000 employees serve clients in approximately 100 countries, provided support for more than 75% of the new drugs and therapeutic products approved in 2024 by the FDA, and perform more than 700 million tests annually for patients around the world. Learn more about us at www.labcorp.com.

SOURCE Labcorp