News Report | August 1, 2022
FDA Grants Breakthrough Device Designation To Roche ‘Elecsys Amyloid Plasma Panel’ Blood Biomarker Test For Alzheimer’s Disease
The U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Elecsys® Amyloid Plasma Panel manufactured by Roche, a biotechnology company. The panel is intended to be used in conjunction with other clinical information for people with cognitive decline who are being evaluated for Alzheimer's disease and other causes of cognitive decline. Roche announced the designation on July 19, 2022. It has not announced when the device might launch for commercial use.
Currently, an Alzheimer’s diagnosis is largely based on clinical symptoms of cognitive decline and a cognitive assessment. The Elecsys panel is intended to . . .