Roche’s Alzheimer’s Early Detection Test Earns Breakthrough Nod

Roche has earned U.S. Food and Drug Administration (FDA) breakthrough status for its Elecsys Amyloid Plasma Panel, a solution to provide earlier detection of Alzheimer’s disease.
 
The test spots and measures Alzheimer’s biomarkers in blood plasma to indicate need for further confirmatory testing. According to the company, Roche is the first in-vitro diagnostics maker to earn this designation for a blood-based biomarker test from the FDA.
 
“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,” Thomas Schinecker, CEO of Roche Diagnostics told the press. “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.”
 
Alzheimer’s diagnosis is currently largely based on clinical symptoms, with a significant number of patients diagnosed when the disease has already progressed. The Elecsys Amyloid Protein Panel is a qualitative test that combines the result of the phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human plasma.
 
pTau elevations happen in early stages of Alzheimer’s, and presence of APOE E4 is the most common genetic risk factor for the disease. Further confirmatory testing can be done either with PET scan or cerebrospinal fluid testing.
 
Roche also gained breakthrough status 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 or other causes of dementia.
 
Roche has launched the Elecsys HCV Duo immunoassay in countries accepting the CE mark earlier this week.