FDA Clears First Blood Test for Alzheimer's Diagnosis

Plasma assessment is not intended as a screening or stand-alone diagnostic test, agency saysThe FDA cleared the first blood-based in vitro diagnostic test for Alzheimer's disease, the agency announcedopens in a new tab or window Friday. The blood test, known as the Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio, can be used to detect amyloid plaques associated with Alzheimer's in people ages 55 and older who have signs and symptoms of the disease, the agency said. "Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined," FDA Commissioner Martin Makary, MD, MPH, said in a statement....