Pharma Focus Europe

Roche Receives FDA Breakthrough Device Designation for Early Alzheimer's Blood Test

The Elecsys pTau217 assay developed by Roche in collaboration with Eli Lilly and Company is a blood test designed to detect amyloid pathology.

It aims to aid in the timely diagnosis of Alzheimer's disease by identifying the presence or absence of certain biomarkers, specifically pTau217, which is a phosphorylated fragment of the tau protein.

This biomarker has shown promise in research for distinguishing Alzheimer's disease from other neurodegenerative disorders with strong performance relative to other biomarkers.

The incidence of dementia is increasing worldwide, with an estimated 75% of cases remaining undiagnosed.

If approved by the FDA, this assay could significantly improve access to timely and accurate Alzheimer's disease diagnosis, potentially enabling earlier intervention and treatment.

The Commited plans to use its extensive diagnostic system infrastructure, the largest globally, to ensure broad access to this important test, aiming to improve patient outcomes globally.

They aim to enhance the speed and scale of testing and diagnosis in this critical area of unmet medical need through their collaboration, focusing on pTau217.
 

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