Roche announced on Tuesday that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Elecsys Amyloid Plasma Panel for the detection of Alzheimer’s disease.
The panel, a blood-based biomarker test, is intended to be used in conjunction with other clinical information in symptomatic patients who are being evaluated for Alzheimer's disease and other causes of cognitive decline.
The Elecsys Amyloid Plasma Panel has the potential to ensure better identification of patients who require further confirmatory testing, supporting a more timely and accessible diagnosis, Roche said.
