FDA Clears First Blood Test to Reliably Predict Alzheimer’s Disease
- On Friday, federal health authorities approved the first blood test in the United States designed to aid in diagnosing Alzheimer's disease.
- This clearance follows a need for less invasive, reliable detection methods since existing ones required spinal fluid or radioactive imaging.
- The test by Lumipulse measures protein ratios linked to brain amyloid plaques in blood samples from patients 55 or older showing Alzheimer's symptoms.
- Lumipulse's test showed over 91% success in prior trials and Dr. Michelle Tarver noted nearly 7 million Americans live with Alzheimer's, expected to reach nearly 13 million.
- This FDA approval may improve diagnosis accessibility, aid treatment decisions, and support expanding use of drugs that modestly slow Alzheimer's progression.
159 Articles
159 Articles


FDA clears first blood test to diagnose Alzheimer’s disease
U.S. regulators have approved the first blood test to help diagnose Alzheimer’s disease, potentially making it easier to find and treat patients with the mind-robbing disease that affects nearly 7 million Americans.
Alzheimer's: The United States Approves First Blood Screening Test
The United States gave its green light on Friday for the first blood test for Alzheimer's disease, which could allow patients to take drugs earlier to slow the progression of this neurodegenerative disease.

Statement from the Alzheimer's Drug Discovery Foundation (ADDF) on FDA Approval of the First Blood Test to Aid in Alzheimer's Diagnosis
NEW YORK, May 16, 2025 /PRNewswire/ -- Today, the FDA's approved the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, marking a pivotal moment in the fight against Alzheimer's disease. This is the first blood test authorized to aid in the diagnosis…
Coverage Details
Bias Distribution
- 66% of the sources are Center
To view factuality data please Upgrade to Premium
Ownership
To view ownership data please Upgrade to Vantage