Roche’s Elecsys pTau181 Test Receives the US FDA’s Clearance to Rule Out Alzheimer’s Disease

Shots:

• The US FDA has cleared the Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.)
• Elecsys pTau181 was evaluated in a non-interventional study of 312 participants, showing 97.9% negative predictive value (NPV) in an early disease-stage, low-prevalence population
• Elecsys pTau217 is an in-vitro diagnostic test that quantifies Phospho-Tau in plasma to help identify amyloid pathology

Ref: Roche | Image: Roche | Press Release

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