The U.S. Food and Drug Administration has approved the first blood test designed to help diagnose Alzheimer’s disease, a move experts say could dramatically improve access to earlier, more accurate diagnoses, particularly for older Americans experiencing memory and thinking problems.
The test, called Lumipulse, detects amyloid plaques—clumps of abnormal protein in the brain that disrupt brain cell function and are strongly associated with Alzheimer’s.
Until now, doctors have relied on expensive PET scans or invasive spinal fluid tests to detect amyloid, both of which are often difficult to access, especially in rural areas.
Lumipulse requires only a standard blood draw from patients 55 and older who are showing symptoms of cognitive decline.
“Having a blood test just makes it so much easier in being able to make a diagnosis of Alzheimer’s disease,” said Dr. Charles Bernick, a neurologist with the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas.
The test, developed by Fujirebio Diagnostics, was authorized on May 16 and is intended to be used alongside other evaluations—not as a standalone diagnostic tool.
It is not designed for people who do not have symptoms.
The FDA emphasized that a full clinical assessment, including cognitive testing and possibly imaging, remains essential for a diagnosis.
According to the FDA, Lumipulse works by measuring the ratio of two proteins in plasma, which can indicate the likely presence or absence of amyloid plaques, potentially reducing the need for PET imaging.
Fujirebio has not released pricing information, but experts suggest FDA clearance could lead to broader insurance coverage and more widespread use of the test.
In recent years, two medications—Leqembi and Kisunla—have been approved to slow the progression of Alzheimer’s in its early stages.
Because both treatments work by removing amyloid plaques from the brain, confirming the presence of those plaques is a necessary step before prescribing.
The new blood test could help patients more easily determine whether they’re eligible for such drugs.
“They carry some risk,” Bernick said of the medications, “so if you’re going to use them or utilize them, you’ve got to be pretty sure the person has that protein in the brain.”
The risks can include brain swelling or bleeding.
Blood-based tests for Alzheimer’s have already been in use at some clinics as laboratory-developed tests, which do not require FDA approval.
However, full authorization confirms a test’s accuracy and reliability, paving the way for greater clinical use and insurance reimbursement.
Experts and advocacy organizations praised the FDA’s decision. Howard Fillit, M.D., co-founder of the Alzheimer’s Drug Discovery Foundation, said the approval “will revolutionize clinical care and clinical research” by enabling earlier diagnoses and opening the door to participation in clinical trials.
“It’s going to reduce the cost of care and diagnosis, and it’s going to give people the opportunity to get a definitive diagnosis,” Fillit told AARP.
Maria Carrillo, chief science officer at the Alzheimer’s Association, called the approval a “major step forward.”
“For too long, Americans have struggled to get a simple and accurate diagnosis; with today’s action by the FDA we are hopeful it will be easier for more individuals to receive an accurate diagnosis earlier,” Carrillo said in a statement.
Looking ahead, Fillit said he expects more blood-based Alzheimer’s tests to become available, including those that detect additional biomarkers such as brain inflammation.
He predicted that Alzheimer’s diagnosis and care will eventually resemble cancer care—personalized, multi-drug treatment plans based on detailed biological markers.
“This is just the beginning of really going into a new age of Alzheimer’s disease diagnosis and care and clinical trials,” Fillit said.
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