Labcorp to Launch First FDA Cleared Blood Test for Alzheimer’s in Primary Care

Labcorp has announced plans to offer the Elecsys pTau181 test, the first and only blood test cleared by the U.S. Food and Drug Administration (FDA) to support the initial assessment of Alzheimer’s disease and other causes of cognitive decline in primary care. 

Currently, more than 7.2 million Americans live with Alzheimer’s disease, a figure projected to nearly double by 2050.

The Elecsys pTau181 test is designed for adults aged 55 and older who show symptoms or concerns related to cognitive decline. 

It enables clinicians to rule out Alzheimer’s-related amyloid pathology and determine whether patients require further specialist evaluation.

The test measures phosphorylated Tau (pTau) 181 protein in plasma, a key biomarker associated with Alzheimer’s pathology. 

Clinical studies have shown a 97.9% negative predictive value, meaning a negative result suggests a low likelihood of Alzheimer’s-related amyloid build-up.

Performed through a simple blood draw, the test provides a more accessible, affordable, and less invasive alternative to cerebrospinal fluid testing or PET scans. 

Labcorp plans to make the test available through its nationwide network of more than 2,200 patient service centres, reinforcing its leadership in expanding access to Alzheimer’s diagnostic tools.