The first in vitro diagnostic device that uses blood samples to detect Alzheimer disease has been granted marketing clearance by the U.S. Food and Drug Administration. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is approved for the early detection of amyloid plaques associated with Alzheimer disease in patients aged 55 years and older who are showing signs of the disease.

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.