FDA support advances biomarker for earlier, more precise Parkinson's clinical trials

The Critical Path Institute (C-Path) has published "Regulatory endorsement for the application of alpha-synuclein seed amplification assay (αSyn-SAA) as a susceptibility and risk biomarker for clinical trials targeting synucleinopathies" in the Journal of Parkinson's Disease, marking a significant milestone for its Critical Path for Parkinson's consortium. The findings detail scientific, regulatory and collaborative efforts culminating in a U.S. Food and Drug Administration (FDA) biomarker Letter of Support for this work.