SOUTH SAN FRANCISCO (dpa-AFX) - Roche (RHHBY) on Tuesday said its Elecsys Amyloid Plasma Panel received Breakthrough Device Designation from the Food and Drug Administration to detect Alzheimer's disease.
Elecsys Amyloid Plasma Panel test detects and measures Alzheimer's disease biomarkers in the blood plasma to identify patients who require further confirmatory testing.
Roche said it is the first in-vitro diagnostics manufacturer to receive this designation for a blood-based biomarker test for Alzheimer's.
'Our new diagnostics test has the potential to streamline a patient's journey, improving speed and access toward a confirmatory diagnosis, giving people with Alzheimer's disease and their caregivers more time to plan and prepare for the future,' said Thomas Schinecker, CEO of Roche Diagnostics.
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