FDA Approval of Donanemab Highlights C2N Diagnostics' Contribution to Alzheimer's Disease Pathology Understanding

Thursday, July 04, 2024

C2N Diagnostics is closely following the FDA's recent approval of donanemab for treating early Alzheimer's disease.

This decision comes after the successful use of C2N’s Precivity-p-tau217 blood biomarker in the Phase 3 clinical trial and analysis for donanemab, highlighted in the "TRAILBLAZER-ALZ 2 Randomized Clinical Trial" published in the Journal of the American Medical Association.

Eli Lilly and Company reports that donanemab significantly slowed cognitive and functional decline in individuals with early symptomatic Alzheimer's disease.

Exploratory outcomes, including changes in plasma p-tau217 over 76 weeks and other time-based analyses, underscore the therapy's potential to slow disease progression, though it is not a cure.

C2N sees itself as pivotal in confirming Alzheimer’s disease pathology with its Precivity™ portfolio.

The PrecivityAD2™ blood test, designed to align with current PET scans and cerebrospinal fluid tests, aims to fill diagnostic gaps in evaluating patients showing signs or symptoms of Alzheimer’s disease or other forms of cognitive decline.

The Precivity™ tests demonstrate high accuracy and serve as vital tools for evaluating new treatment approaches.

Our experience supporting clinical trials for donanemab and previously approved lecanemab underscores our commitment to advancing brain health diagnostics.

C2N is dedicated to facilitating access to innovative treatments for patients.

The PrecivityAD2™ test utilizes an Amyloid Probability Score 2 (APS2) that integrates precise measurements of p-tau217/np-tau217 Ratio and Aβ42/40 Ratio into a validated algorithm.

This APS2 score shows significant correlation with brain amyloid pathology measured by PET scan, surpassing the predictive power of individual biomarker measurements alone.






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