Roche’s Elecsys Amyloid Plasma Panel granted FDA Breakthrough Device Designation to enable a
timely diagnosis of Alzheimer’s disease.
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the
Elecsys® Amyloid Plasma Panel, an innovative new solution to enable Alzheimer’s disease to be
detected earlier.
The Elecsys Amyloid Plasma Panel test detects and measures Alzheimer’s disease
biomarkers in blood plasma to indicate the need for further confirmatory testing for Alzheimer’s
disease.
Roche is the first in-vitro diagnostics manufacturer to receive this designation for a blood-
based biomarker test for Alzheimer’s:
➡️️ The Elecsys Amyloid Plasma Panel 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
that require further confirmatory testing, supporting a more timely and accessible diagnosis.
➡️️ This minimally invasive blood-based biomarker test can help to streamline a patient’s journey,
improving access to diagnosis and helping them better plan for the future.
The key to transforming the life of people with Alzheimer’s disease is to diagnose as early as possible
and intervene with the right care plans!
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