FDA grants Breakthrough Device Designation for Roche’s Elecsys cerebrospinal fluid (CSF) assays to support diagnosis of Alzheimer’s disease
Currently, the main type of diagnostics used to diagnose Alzheimer’s disease (AD) are based upon clinical manifestations such as cognitive testing. A breakthrough in AD diagnostics has been approved by the Food and Drug Administration (FDA). Device Designation to Elecsys® beta-Amyloid (1-42) CSF and Elecsys® Phospho-Tau (181P) CSF is an in vitro diagnostic immunoassay used for measuring beta-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal fluid (CSF) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other causes of dementia. The importance in applying biomarker analysis as a diagnostic tool aids in evaluating the progressing of the disease.