Roundtable Discussion: Harmonising Fluid‑Biomarker Assays Across Sites for Regulatory Confidence
- Aligning plasma p‑Tau217 assays and shared cut‑offs across trial labs standardises early‑stage Alzheimer’s screening and cuts unnecessary PET scans and enrolment delays
- Quantifying the α‑synuclein RT‑QuIC seeding assay with synthetic calibrators converts a yes/no read‑out into a dose‑response biomarker, permitting smaller, mechanism‑rich Parkinson’s studies
- Benchmarking CSF dopa‑decarboxylase alongside NFL in AMP‑PD biobank samples harmonises Parkinson’s progression metrics across sites and boosts regulator confidence in multicentre data packages