The U.S. Food and Drug Administration (FDA) has granted approval for a first-of-its-kind blood test to help diagnose Alzheimer’s disease, which could help people begin treatment in the early stages of the illness.
The new Lumipulse blood test can determine the presence of amyloid plaques (a hallmark of Alzheimer’s disease) in the brains of adults 55 and older who are experiencing early signs and symptoms of the condition.
From a simple blood draw, this diagnostic tool measures two proteins (pTau217 and β-amyloid 1-42) found in human plasma. These proteins indicate the presence of harmful plaques that form between brain nerve cells and disrupt normal brain function.
Alzheimer’s disease develops over many years, long before symptoms are evident, but the lack of accessible, minimally invasive diagnostic tests results in many people remaining undiagnosed until the disease is well advanced, when few effective interventions remain.
“This test is a revolution in Alzheimer’s disease both from a diagnostic and treatment point of view,” says Howard Fillit, MD, a cofounder and the chief scientific officer for the Alzheimer’s Drug Discovery Foundation (ADDF). “Even as recently as 5 or 10 years ago, I never thought there would be a blood test for Alzheimer’s disease, so this is really amazing progress.”
A Blood Test For Alzheimer's?
A new finding suggests that someday a blood test might be able to predict who will get Alzheimer’s Disease. According to a new study, people with the highest blood levels of one specific fat were 10 times more likely to get the condition.
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Alzheimer’s Blood Test Was Highly Accurate in Clinical Trial
Approval of the Lumipulse test was based on the FDA’s evaluation of data from 499 individual blood samples from cognitively impaired adults.
The samples were analyzed by the Lumipulse test and compared with amyloid positron emission tomography (PET) scan or spinal tap test results, two well-established ways to determine the presence of amyloid plaques in the brain.
Researchers found that nearly 92 percent of individuals who tested positive for amyloid plaques with the Lumipulse test also had evidence of amyloid plaques verified by PET scans or spinal taps.
Just over 97 percent of those with negative results from the Lumipulse test had a negative amyloid PET scan or spinal tap result.
Less than one-fifth of the 499 patients tested received an indeterminate Lumipulse result.
The FDA noted that the Lumipulse blood test outcomes were “substantially equivalent” to a similar, previously authorized Lumipulse test that uses spinal tap samples.
Blood Test for Alzheimer’s Could Make Diagnosis Easier and More Readily Available
PET scans and spinal taps are highly accurate when it comes to identifying amyloid plaques — but they are expensive, invasive, time-consuming, and can have limited availability, according to Dr. Fillit.
He estimates a blood analysis like the Lumipulse test might cost $500 to $1,000. A PET scan, by contrast, can cost as much as $6,000 to $8,000. A blood draw is also far easier and less time-consuming than brain imaging, and it doesn’t expose a patient to radiation.
A spinal tap is also pricier, sometimes costing thousands of dollars.
Monte Wiltse, president and CEO at Fujirebio Diagnostics, the manufacturer of the blood test, expects that the tool may help more people get an official diagnosis sooner so they can receive appropriate treatment, including medications that can slow Alzheimer’s progression.
“The lack of effective, accessible, and minimally invasive diagnostics for Alzheimer’s disease contributes to its late diagnosis and inadequate treatment,” said Wiltse in a statement.
A Promising New Piece to the Diagnostic Puzzle
While Lumipulse is the first FDA-approved blood test for Alzheimer’s diagnosis, other similar tests are available, but they are not yet authorized by the FDA. These include the AD-Detect Test for Alzheimer’s Disease and Precivity. Fillit expects that we will see more blood tests gain FDA approval in the near future.
No blood test, including Lumipulse, can diagnose Alzheimer’s disease alone, according to the Alzheimer’s Association.
Increasingly, however, specialists in clinical settings are using blood tests as a first-pass detection tool. The Alzheimer’s Association says that blood testing could become a more common piece of the diagnostic process, along with medical history, neurological exams, and cognitive and functional assessments.
It’s still unclear how healthcare providers will incorporate the Lumipulse test into everyday practice, according to Fillit.
“There have been medical papers that address this question: What happens when a person gets a positive blood test? Do they need a brain scan? I don’t think that issue has been fully resolved yet by organizations like the American Academy of Neurology and the American College of Physicians,” he says.
“This is just the beginning of a real revolution of how diagnosis is going to be made. As blood-based biomarkers continue to evolve, they will fundamentally reshape the landscape of Alzheimer’s care, creating a new landscape where precision medicine and prevention of the disease are possible,” Fillit says.
New Blood Test May Prove Popular
The 2025 Alzheimer Association report found that nearly 4 in 5 Americans surveyed would want to know if they had Alzheimer’s disease before it impacted their lives, and 9 out of 10 say they would want to take a simple test — such as a blood biomarker test — if it were available.
Access to early treatment and care is the main reason cited for wanting a simple test.
EDITORIAL SOURCES
Everyday Health follows strict sourcing guidelines to ensure the accuracy of its content, outlined in our editorial policy. We use only trustworthy sources, including peer-reviewed studies, board-certified medical experts, patients with lived experience, and information from top institutions.
Fujirebio Receives Marketing Clearance for Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio In-Vitro Diagnostic Test As An Aid To Identify Patients With Amyloid Pathology Associated With Alzheimer’s Disease. Fujirebio. May 16, 2025.
Blood Test Can Predict Presence of Beta-Amyloid in the Brain, New Study Finds. National Institute on Aging. February 17, 2022.
Quest Introduces First-To-Market Consumer-Initiated Blood Test for Alzheimer’s Disease Risk Assessment on Questhealth.com. Quest Diagnostics. July 31, 2023.
Alzheimer’s Association Statement on First Blood Test Used in Diagnosing Alzheimer’s Disease Cleared for Use by FDA. Alzheimer’s Association. May 16, 2025.
American Perspectives on Early Detection of Alzheimer's Disease in the Era of Treatment. Alzheimer’s Association. 2025.
Tom Gavin joined Everyday Health as copy chief in 2022 after a lengthy stint as a freelance copy editor. He has a bachelor's degree in psychology from College of the Holy Cross.
Prior to working for Everyday Health, he wrote, edited, copyedited, and fact-checked for books, magazines, and digital content covering a range of topics, including women's health, lifestyle, recipes, restaurant reviews, travel, and more. His clients have included Frommer's, Time-Life, and Google, among others.
He lives in Brooklyn, New York, where he likes to spend his time making music, fixing too-old electronics, and having fun with his family and the dog who has taken up residence in their home.
Don Rauf has been a freelance health writer for over 12 years and his writing has been featured in HealthDay, CBS News, WebMD, U.S. News & World Report, Mental Floss, United Press International (UPI), Health, and MedicineNet. He was previously a reporter for DailyRx.com where he covered stories related to cardiology, diabetes, lung cancer, prostate cancer, erectile dysfunction, menopause, and allergies. He has interviewed doctors and pharmaceutical representatives in the U.S. and abroad.
He is a prolific writer and has written more than 50 books, including Lost America: Vanished Civilizations, Abandoned Towns, and Roadside Attractions. Rauf lives in Seattle, Washington.
