Labcorp introduces Roche’s FDA-cleared blood test for Alzheimer's disease assessment in primary care
Labcorp has made the Elecsys pTau-181 test accessible nationwide, according to an announcement. This is 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.
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 features of the Elecsys pTau-181 test:
- Offers 97.9% negative predictive value
- Is performed via a simple blood draw
- 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 shortageopens in a new tab of neurologists, supporting timely evaluation of other causes of cognitive decline
