Labcorp Debuts FDA-Cleared Elecsys pTau-181 Blood Test with 97.9% NPV
Labcorp launched the Elecsys pTau-181, the first FDA-cleared blood test for Alzheimer’s assessment in primary care, available nationwide for patients aged 55+ with 97.9% negative predictive value. The test uses a simple blood draw at over 2,200 service centers, cutting reliance on costly scans and specialist referrals.
1. Launch Details
Labcorp has begun offering the Elecsys pTau-181 blood test for Alzheimer’s assessment in primary care, marking the first FDA-cleared biomarker test of its kind in this setting. The service is available nationwide for symptomatic patients aged 55 and older at more than 2,200 patient service centers.
2. Clinical Benefits
The test delivers a 97.9% negative predictive value, enabling clinicians to rule out amyloid pathology via a simple blood draw. This approach reduces dependence on costly or invasive brain scans and lumbar punctures and decreases unnecessary specialist referrals.
3. Strategic Impact
Developed by Roche Diagnostics and cleared in 2025, Elecsys pTau-181 strengthens Labcorp’s portfolio of neurodegenerative disease biomarkers. The launch supports Labcorp’s strategy to expand primary care diagnostic offerings and capture increased market share in Alzheimer’s testing services.