FDA grants Breakthrough Device Designation for Roche's Elecsys cerebrospinal fluid
Roche announced the 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 measurement of the ß-Amyloid and Phospho-Tau concentrations in CSF in adult patients. July 20, 2018