On May 16, 2025, the U.S. Food and Drug Administration (FDA) approved a groundbreaking new blood test that helps doctors diagnose Alzheimer’s disease more easily and less invasively. Called the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, this test can detect signs of Alzheimer’s in the blood, rather than requiring patients to undergo expensive brain scans (PET scans) or painful spinal taps to collect fluid from the spine.
Alzheimer’s disease is a serious brain disorder that gradually destroys memory and thinking skills. It affects millions of Americans—more than breast and prostate cancer combined—and the number of people with the disease is expected to nearly double by 2050. One key feature of Alzheimer’s is the buildup of harmful protein clumps in the brain called amyloid plaques. This new test helps doctors detect those plaques by measuring two specific proteins in a person’s blood.
In a study of nearly 500 people with memory problems, the new blood test was found to be very accurate: over 91% of people with a positive test had amyloid plaques, and over 97% of those with a negative test didn’t. Only a small number of people received unclear results.
While this test isn’t meant to be used on its own or for general screening, it’s a powerful tool for doctors working with patients showing signs of Alzheimer’s. It could help patients get a diagnosis sooner, with less stress, lower costs, and fewer risks than current methods.
The FDA cleared this test through a special fast-track process for important new medical tools. It was developed by Fujirebio Diagnostics, Inc. and is a major step forward in making Alzheimer’s diagnosis more accessible and patient-friendly.
Access the full text of the FDA press release here.