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Fall 2022 - Innovation

New Test Detects and Measures Biomarkers in Blood Plasma to Earlier Diagnose Alzheimer’s

FDA has granted breakthrough device designation to Roche’s Elecsys Amyloid Plasma Panel, a new solution to enable Alzheimer’s disease to be detected earlier. 

The U.S. Food and Drug Administration has granted breakthrough device designation to Roche’s Elecsys Amyloid Plasma Panel, a new solution to enable Alzheimer’s disease to be detected earlier. The 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.

Currently, the diagnosis of Alzheimer’s disease is largely based on clinical symp-toms, including cognitive assessment, with a significant number of patients diagnosed when their disease has already advanced. The Elecsys Amyloid Plasma Panel is the first qualitative test that combines the result of the phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human plasma. Elevations in pTau occur in early stages of Alzheimer’s, while the presence of APOE E4 constitutes the most common genetic risk factor for Alzheimer’s disease. Patients testing negative with the Elecsys Amyloid Plasma Panel are unlikely to be amyloid positive and should be investigated for other causes of cognitive decline.

The test has the potential to ensure better identification of patients who require further confirmatory testing, which could be done via PET scan or cerebrospinal fluid (CSF) testing, supporting a more timely and accessible diagnosis. In conjunction with other diagnostic tools and the work Roche is doing in developing potential new treatments, this could be an important building-block toward improved care and outcomes for people with Alzheimer’s disease.

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 CSF in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease or other causes of dementia.


F. Hoffman-La Roche Ltd. Roche’s Elecsys Amyloid Plasma Panel Granted FDA Breakthrough Device Designation to Enable a Timely Diagnosis of Alzheimer’s Disease. GlobalNewswire, July 19, 2022. Accessed at

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.