Roche and Eli Lilly won U.S. FDA clearance for the Elecsys Phospho-Tau (217P) Plasma blood test, designed to detect amyloid pathology tied to Alzheimer’s disease. The assay is intended for people ages 55 and older who present with signs, symptoms, or complaints of cognitive decline. It adds to the growing menu of blood-based biomarkers that can help clinicians identify Alzheimer’s pathology without waiting for more invasive or imaging-based confirmation. For Roche and Lilly, the decision extends their footprint in plasma biomarker testing and reinforces a shift toward earlier, easier-to-scale diagnostics in neurodegeneration.