Roche bags USFDA Breakthrough Device Designation for Elecsys Amyloid Plasma Panel for early detection of Alzheimer's disease
Alzheimer's disease is the most common form of dementia.
Basel: Roche has announced that the U.S. Food and Drug Administration (USFDA) has granted Breakthrough Device Designation to the Elecsys Amyloid Plasma Panel, a 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.
Alzheimer's disease is the most common form of dementia. Dementia affects more than 55 million people worldwide with more than 10 million new cases each year. Barriers to early and accurate diagnosis of Alzheimer's disease exist across the globe – up to 3 out of 4 people living with symptoms of Alzheimer's disease have not been diagnosed, and those who have received a diagnosis, on average waited 2.8 years.
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