Roche’s Elecsys Amyloid Plasma Panel and the Elecsys AD CSF Assays:
The Elecsys Amyloid Plasma Panel Test:In July 2022, the U.S. FDA granted Breakthrough Device designation to Roche Diagnostic’s Elecsys Amyloid Plasma panel, which detects and measures Alzheimer’s disease biomarkers in blood plasma. The panel is used to determine the need for further confirmatory testing for AD.
The Elecsys Amyloid Plasma Panel measures both the phosphorylated Tau (pTau) 181 protein and apolipoprotein (APOE) E4 in human plasma. Elevations in pTau occur in the early stages of Alzheimer’s, while the presence of APOE E4 constitutes the most common genetic risk factor for Alzheimer’s disease. The result of the test is intended for consideration in conjunction with other clinical information to advise for further confirmatory testing with amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) testing. 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 Elecsys CSF Assays: In early December 2022, Roche Diagnostics received FDA Breakthrough Device approval for its Elecsys CSF assays to detect AD. The Elecsys CSF assays consist of two CSF diagnostic immunoassays, the Elecsys B-Amyloid (1-42) assay, and the Elecsys Phospho-Tau (181P) test. The tests measure B-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.
