Roche Diagnostics
Member
Roche Diagnostics is a division of Roche Group, the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. With over two decades of scientific research in Alzheimer’s, Roche has made meaningful contributions to the field by driving understanding of the biology and underlying pathology of the disease and has persisted when faced with disappointments. Roche continues to listen to and closely collaborate with the Alzheimer’s community, learning from setbacks and building on each success. Roche is developing and delivering solutions to more effectively detect, diagnose, and monitor the disease and progressing research with our investigational medicines for different targets, types, and stages of the disease. Today, our Alzheimer’s portfolio includes tests to help detect and diagnose Alzheimer’s early as well as monitor disease progression:
- Investigational blood-based biomarker tests to help streamline individuals toward confirmatory testing.
- Cerebrospinal fluid assays that measure two hallmarks of Alzheimer’s – beta-amyloid and tau – to confirm the disease’s pathology.
- Digital biomarkers that we are developing to remotely monitor the cognition, function and behavior of people with early Alzheimer’s in their daily lives.
In July 2022, the U.S. Food and Drug Administration (FDA) 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. Roche has also received a Breakthrough Device Designation for the Elecsys® ß-Amyloid (1-42) CSF and Elecsys® Phospho-Tau (181P) CSF in vitro diagnostic immunoassays measuring ß-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal fluid (CSF) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other causes of dementia. For more information, visit https://diagnostics.roche.com/.