May 28, 2025
In May 2025, the Food and Drug Administration approved the first blood test for diagnosing Alzheimer’s disease. The test, known as the Lumipulse blood test, is less invasive and easier to perform than the brain scans and spinal taps currently used to diagnose the illness. The test may be used help to determine whether memory loss and thinking problems are a result of Alzheimer’s and could allow patients earlier access to drugs currently approved to treat the disease. Other blood tests have been used to screen patients for Alzheimer’s clinical trials, but this is the first one to be cleared by the FDA.
“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said Dr. Martin A. Makary, the FDA Commissioner. “Knowing that 10 percent of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.” Here’s what to know about the newly approved Lumipulse test.
How is the Lumipulse blood test performed?
The new test requires a simple blood draw so that doctors can analyze plasma, a component of blood. The test, officially known as the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, calculates a ratio of two proteins that are each a hallmark of Alzheimer’s disease: beta-amyloid and tau. Beta-amyloid, in its toxic form, begins to accumulate in the brain up to 20 years before symptoms of Alzheimer’s appear. As levels of the protein increase, they clump together to form rough, hard amyloid plaques in the space between cells that choke off healthy brain cells. The tau protein begins to accumulate later, forming spaghetti-like tangles inside neurons that disrupt their communication with other brain cells.
The Lumipulse blood test is made by Japanese company, Fujirebio Diagnostics. An earlier version of the Lumipulse test was approved in 2022, but that test required a much more invasive lumbar puncture, or spinal tap, to get a sample of the cerebrospinal fluid (CSF) that bathes the spinal cord.
Can anyone get the blood test?
It is not intended as a screening test for healthy individuals, so people who don’t have symptoms shouldn’t get tested. The Lumipulse test is approved only for adults aged 55 or older who are experiencing memory or thinking problems typical of Alzheimer’s disease. The test should be performed by Alzheimer’s specialists in memory clinics or other specialized care settings. Results should be interpreted by specialists in conjunction with other clinical patient information, including results from neurologic exams and memory tests.
Is the test result definitive?
No, the test is not 100 percent accurate. It can suggest the presence of Alzheimer’s, but additional tests, such as PET brain scans or spinal taps, may be needed to help confirm a diagnosis.
A study of 499 individual plasma samples collected at multiple medical centers from adults who were cognitively impaired compared the Lumipulse blood test with results from PET brain scans or CSF samples. Nearly 92 percent of people who tested positive on the Lumipulse blood test had amyloid plaques that were confirmed by PET scans or CSF test results. More than 97 percent of those who had negative results with the Lumipulse blood test had negative amyloid findings on PET scans or CSF test results.
Sometimes results were inconclusive. Less than 20 percent of the 499 people tested had indeterminate results on the Lumipulse blood test.
Are there risks from the test?
The test requires a simple blood draw, so the test itself does not entail serious health risks. However, a small percentage of people may get a positive result on the test but do not actually have Alzheimer’s (false positives). “False positive results, in conjunction with other clinical information, could lead to an inappropriate diagnosis of, and unnecessary treatment for, Alzheimer’s disease,” the FDA states. “This could lead to psychological distress, delay in receiving a correct diagnosis as well as expense and the risk for side effects from unnecessary treatment.”
A smaller percentage of people may get a negative Lumipulse test result but do actually have Alzheimer’s (false negatives). “False negative results could result in additional unnecessary diagnostic tests and potential delay in effective treatment,” the FDA notes.
Who can benefit from the blood test?
The test can help to discern whether memory loss and other symptoms are a result of Alzheimer’s disease or another form of dementia, such as vascular dementia or Lewy body dementia. It may also help to determine which patients could benefit from the newer drugs for Alzheimer’s disease, such as Kisunla and Leqembi, that target beta-amyloid buildup in the brain.
Lumipulse results can also help to rule out Alzheimer’s. In some cases, memory problems may be the result of another medical problem, such as a tumor or stroke, or the side effect of certain medications.
How much does the test cost? Is it covered by insurance?
The test is rolling out now and is expected to become more widely available in the coming months. The projected cost is estimated at around $500 to $1,000, far less than a PET scan or spinal tap, though the drug maker has not determined the final cost. Because it has been cleared by the FDA, it is expected to be covered by Medicare and other forms of insurance.
What’s next for testing for Alzheimer’s?
The Lumipulse test is the first blood test to be cleared by the FDA, but other blood tests are in development. Some target other measures, such as levels of inflammation in the brain. As experience with the blood test grows and new tests become available, doctors may be able to offer more personalized treatments for individual patients with Alzheimer’s disease.
This article is for informational purposes only and is not an endorsement of the Lumipulse test by the Fisher Center Foundation or its affiliated scientists. Anyone interested in the test should talk to their doctor for more information.
Source: Food and Drug Administration; Fujirebio Diagnostics, Inc.
