Roche and Eli Lilly received U.S. FDA clearance for the Elecsys Phospho-Tau (217P) Plasma test, a blood-based assay intended to identify amyloid pathology associated with Alzheimer’s. The cleared use targets adults 55 and older with signs, symptoms or complaints of cognitive decline, extending the commercial footprint of biomarker-driven diagnosis beyond CSF and existing blood tests. The clearance strengthens the position of plasma biomarkers in clinical workflows and may reshape diagnostic pathway choices for clinicians and payers as additional tau-based tools reach approval.