The FDA cleared PrecivityAD2, a blood test designed to detect Alzheimer’s-linked amyloid pathology and to be marketed as an aid in evaluating Alzheimer’s disease. The assay was developed from technology pioneered at Washington University School of Medicine in St. Louis, and the clearance expands the toolbox beyond CSF and PET. For clinical adoption, the key near-term questions are how the blood test fits diagnostic pathways, how clinicians interpret results alongside imaging and clinical history, and what role it plays for earlier-stage evaluations and care planning. From a sector perspective, the approval supports the ongoing shift toward less invasive biomarkers and will likely influence how trial enrichment and patient stratification are handled as sponsors seek easier screening and monitoring methods.