Roche and Eli Lilly received FDA clearance for the Elecsys Phospho-Tau (217P) Plasma blood test, an assay intended to help identify amyloid pathology in Alzheimer’s disease. The test is designed for individuals aged 55 and older with signs, symptoms, or complaints of cognitive decline. The clearance adds another blood-based biomarker option to U.S. clinical pathways and supports the growing shift toward plasma assays for earlier or more accessible detection of underlying disease biology. For laboratories and health systems, additional clearance can influence test ordering patterns and reimbursement planning.