Pre Diagnostics has announced that its PreADx immunoassay for early detection of Alzheimer’s Disease has successfully completed a clinical evaluation.
The company now plans to further optimize the assay in advance of CE marking in Q2, 2021.
An intracellular approach
Unlike plasma or serum-based assays, PreADx takes an intracellular approach and measures the clearance of beta-amyloid peptides by analyzing a patient’s monocytes. The monocytes are a part of the innate immune system, and stem from the same cell lineage as the microglia and macrophages that clear plaques in the brain. In the blind evaluation of 62 well-characterized samples and controls from the Norwegian multicenter study “Dementia Disease Initiative”, PreADx achieved an ROC AUC of .81 in distinguishing healthy controls from Alzheimer patients. This is in line with the generally recognized threshold for diagnostic accuracy and opens the way for development of a much-needed new wave of early Alzheimer’s Disease assays.
Preparation for CE marking
“Beta-amyloid aggregation is generally considered the first pathological sign of the disease which is why we believe that a validated non-invasive immunoassay that can detect this will prove an invaluable front-line tool for improving Alzheimer’s Disease detection and treatment,” says Charlotte Berg-Svendsen, CCO, Pre Diagnostics AS. “In preparation for CE marking we will now run further samples using an optimized version of the assay, which should also lead to increased accuracy. Further analysis will also give us a better picture of the potential clinical utility of this new biomarker, both alone and in combination with gender, ApoE and age.”
Photo of Charlotte Berg Svendsen: Pre Diagnostics