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FDA approves the first blood test to diagnose Alzheimer’s disease

Researchers say the test could lead to much earlier detection in patients

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Mark Huffman
Reporter

Mark Huffman has covered consumer issues since 2004, with a special focus on protecting and empowering older adults. A former news correspondent for the Associated Press Radio Network, Westwood One, and ConsumerAffairs, Mark brings decades of journalistic experience to RetirementLiving.com. He is passionate about giving consumers a voice and helping them make informed decisions. Mark has also created educational content, including Senior Scam Alert, a video resource designed to help seniors recognize and avoid fraud. He holds a B.A. from the University of Kentucky and lives with his family in Richmond, Virginia.

Photo by Steven HWG on Unsplash

Key Insights

  • The FDA has approved the first blood test to aid in diagnosing Alzheimer’s disease, potentially transforming early detection and treatment.
  • The Lumipulse test offers a less invasive and more accessible alternative to costly brain scans and spinal taps.
  • Experts hail the development as a milestone, while noting its current limitations and the need for continued research.

The U.S. Food and Drug Administration has approved the first blood test to help diagnose Alzheimer’s disease, signaling a breakthrough in how the neurodegenerative condition can be identified and treated. 

Researchers say the test, known as the Lumipulse, could revolutionize the diagnostic process by offering a more accessible and less invasive option than traditional methods.

Alzheimer’s disease is the most common form of dementia, progressively impairing memory, cognitive function, and behavior. Until now, a diagnosis often depended on expensive positron emission tomography (PET) scans or invasive lumbar punctures to detect telltale brain abnormalities, tools not always accessible to patients across communities.

Dr. Michal Schnaider Beeri, director of the Herbert and Jacqueline Krieger Klein Alzheimer’s Research Center within the Rutgers Brain Health Institute, called the blood test a “major milestone” in making Alzheimer’s diagnosis easier and more broadly available.

“Previously, confirming a diagnosis often required costly brain imaging or invasive procedures, which could be barriers for many patients,” she said.

How it works

The new test measures the ratio of two proteins in the blood: pTau217 and ß-Amyloid 1-42—both strongly linked to Alzheimer’s disease. In clinical trials, researchers reported the test demonstrated remarkable accuracy:

  • 91.7% of people who tested positive had amyloid plaques confirmed by PET scans or cerebrospinal fluid tests.
  • 97.3% of individuals who tested negative showed no signs of Alzheimer’s pathology.

“These results surpass many cognitive assessments traditionally used,” Beeri said. “This blood test offers a simpler, less invasive, and more widely accessible way to support accurate detection of amyloid plaques and tau tangles, two of the main pathological markers of Alzheimer’s disease.”

A step toward better outcomes?

Early detection is critical, giving patients and families a head start on medical care, participation in clinical trials, and the ability to plan for the future.

“With approximately 90% accuracy, this blood test enables clinicians to identify Alzheimer’s disease, once initial symptoms have become noticeable,” Beeri said. “This can improve outcomes and quality of life for patients and families, offering hope where barriers once stood.”

However, she cautioned against overreliance on the test. It cannot reliably predict Alzheimer’s in people without symptoms and does not account for other contributing factors like vascular disease or inflammation.