FDA Grants Breakthrough Designation To Roche Biomarker Test To Identify Alzheimer’s Disease

On April 11, 2024, Roche announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to its blood test to support earlier Alzheimer's disease diagnosis. The designation is for the Elecsys Phospho-Tau (217P) assay, which is being developed in collaboration with Eli Lilly and Company. The test will be used to help detect the presence or absence of amyloid pathology, which is a key feature of Alzheimer’s disease.

The FDA Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of a life-threatening . . .