The US Food and Drug Administration (FDA) has approved Fujirebio Diagnostics’ Alzheimer’s disease (AD) blood test to help detect the neurodegenerative disease earlier. The decision makes the diagnostic device, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, the first AD blood test to be cleared by the regulator.

Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with Alzheimer’s disease in symptomatic individuals aged 55 years and older.

A first-of-its-kind blood test developed by Malvern-based Fujirebio Diagnostics to help diagnose Alzheimer’s disease has received clearance from the