Fujirebio Received FDA Clearance for Innovative Lumipulse® G Plasma Biomarker Test, Marking Major Advancement in Identifying Amyloid Pathology Linked to Alzheimer’s Disease
On May 16, 2025, Fujirebio announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test. This groundbreaking test is designed to aid in the assessment of amyloid pathology in individuals undergoing evaluation for Alzheimer’s disease (AD) and other causes of cognitive decline.
This clearance marks a significant milestone, as the Lumipulse pTau 217/β-Amyloid 1-42 test is the fir...