Roche Holding AG and Eli Lilly and Co. received U.S. FDA clearance for the Elecsys Phospho-Tau (217P) Plasma blood test, which helps identify amyloid pathology associated with Alzheimer’s disease. The assay is designed for individuals 55 and older with signs, symptoms or complaints of cognitive decline, and brings another biomarker-based blood test to the U.S. market to help clinicians diagnose patients with Alzheimer’s.
BioWorld Medical technology Regulatory Neurology/psychiatric U.S. FDA