The US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in vitro diagnostic (IVD) test for evaluating amyloid pathology in individuals under assessment for Alzheimer's disease and other cognitive decline causes.

The Food and Drug Administration cleared a new kind of test for Alzheimer’s disease designed to be more accessible and less risky for patients with cognitive decline.

The US Food and Drug Administration has given marketing clearance to a blood test to help diagnose Alzheimer’s disease, making the test the first to get signoff to aid in the early detection of the disease in the United States.