FDA grants Breakthrough Device Designation for Roche ' s Elecsys cerebrospinal fluid (CSF) assays to support the improved diagnosis of Alzheimer ' s disease

Roche announced today, that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Elecsys ® ß-Amyloid (1-42) CSF and Elecsys® Phospho-Tau (181P) CSF. These in vitro diagnostic immunoassays are for the measurement of the ß-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal fluid (CSF) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s dis ease (AD) or other causes of dementia.
Source: Roche Media News - Category: Pharmaceuticals Source Type: news