Roche Elecsys Amyloid Plasma Panel is Breakthrough Device

FDA has granted breakthrough device designation for the Roche Elecsys Amyloid Plasma Panel that detects and measures Alzheimer’s disease biomarkers in blood plasma to indicate the need for further confirmatory testing for the disease. The company says it is the first in-vitro diagnostics manufacturer to receive this designation for a blood-based biomarker test for Alzheimer’s.

Roche says the panel measures phosphorylated Tau 181 (pTAU) protein assay and apolipoprotein (APOE) E4 assay in human blood plasma. Elevations in pTau occur in early stages of Alzheimer’s, it says, while the presence of APOE E4 constitutes the most common genetic risk factor for Alzheimer’s disease. “The result is intended for consideration in conjunction with other clinical information to advise for further confirmatory testing with amyloid positron emission tomography or cerebrospinal fluid testing,” the company says.