Roche Biomarker Tests For Alzheimer’s Disease Gains FDA Breakthrough Designation

On July 20, 2018, Roche announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for Roche's Elecsys cerebrospinal fluid (CSF) tests for Alzheimer’s disease biomarkers to support the improved diagnosis of Alzheimer's disease. The designation is for the Elecsys® ß-Amyloid (1-42) CSF and Elecsys® Phospho-Tau (181P) CSF immunoassay. The two tests measure the CFS concentration of ß-Amyloid and phosphorylated tau (Phospho-Tau), biomarkers of Alzheimer’s disease, in adults with cognitive impairment who are being evaluated for Alzheimer’s disease or other causes of dementia.

In July 2017, findings about . . .