The FDA cleared PrecivityAD2, a blood test designed to help evaluate Alzheimer’s disease by detecting amyloid pathology. The test was developed and validated using technology pioneered at Washington University School of Medicine in St. Louis. The clearance supports the expanding role of plasma biomarkers in Alzheimer’s workflows, potentially enabling earlier identification of amyloid pathology without requiring a specialized imaging procedure. PrecivityAD2 is intended as an aid, rather than a standalone diagnostic, in clinical evaluation. Regulatory acceptance of blood-based amyloid tests can influence how trials screen for eligible biomarker-positive patients and how clinicians triage patients for downstream confirmatory testing. It also signals continued FDA confidence in the clinical utility of liquid biomarker data. For industry, the update strengthens a competitive category where sensitivity, specificity, and longitudinal interpretation remain key differentiators.