Roche ' s Elecsys Amyloid Plasma Panel granted FDA Breakthrough Device Designation to enable a timely diagnosis of Alzheimer ’s disease

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.Basel, 19 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that 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. Roc he is the first in-vitro diagnostics manufacturer to receive this designation for a blood-based biomarker test for Alzheimer’s.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.1 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...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news