FDA grants Breakthrough Device Designation for Roche’s Elecsys cerebrospinal fluid (CSF) assays to support diagnosis of Alzheimer’s disease
Roche announced in July 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 […]
