FDA Approves First Alzheimer’s Blood Test

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On May 21, 2025

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.

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.”

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.

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.