FDA Allows Marketing of the First Blood Test for Diagnosing Alzheimer’sNew test for this form of dementia can help diagnose and treat more patients faster
Alzheimer’s disease is the most common cause of dementia, and it’s the seventh leading cause of death in the United States. It’s a complicated illness that can be difficult to […]
Alzheimer’s disease is the most common cause of dementia, and it’s the seventh leading cause of death in the United States. It’s a complicated illness that can be difficult to diagnose without expensive equipment or invasive procedures — until now.
The Food and Drug Administration (FDA) in May cleared for marketing Lumipulse, the first blood test to aid in the diagnosis of Alzheimer’s disease. It is meant for adults 55 and over who show signs of Alzheimer’s disease, such as memory loss.
As of June 2025, this blood test can be ordered by physicians to help determine if Alzheimer’s is the cause of a patient’s symptoms. It will help play a major role in catching the disease earlier, as it detects the ratio of two key proteins in the blood that might suggest the presence of amyloid plaques in the brain that are markers of this condition.
“This is great news, and when it’s fully implemented, it will be a game changer in some ways,” Dr. Sayed Azizi, clinical chief of neurodegenerative disorders at Yale Medicine, said of the test.
Alzheimer’s is a specific type of dementia, most commonly affecting older adults. It currently does not have a cure, but there are approved treatments that help patients maintain independence for longer. These treatments require early intervention for them to be more effective; this new blood test can help with this.
There are other methods to detect the presence of the brain plaques associated with Alzheimer’s: a spinal tap (lumbar puncture) or a PET scan. The former is invasive, requiring a large needle in the lower spine to collect cerebrospinal fluid. The latter may not be accessible in all areas, notably rural ones with fewer resources in hospitals.
These tests are typically more expensive, as well. A blood test is a simpler and faster way to detect a specific ratio of key proteins that can suggest the presence of amyloid plaques in the brain.
Azizi had a clever analogy for describing how amyloid plaques affect a brain with Alzheimer’s: “Think of the brain as an engine, and the engine gets rusty over time. We all get a little bit of rust, but some people get a little bit more and a little bit earlier. And if you get rust in an engine, its wheels don’t turn very well.
“Plaque is like rust, and in some people, it causes memory and cognition problems.”
Receiving a dementia diagnosis can be very difficult for patients and their loved ones. As the disease progresses, patients tend to experience extreme memory loss, mood swings and major cognitive decline. A faster diagnosis can mean more time to prepare, spend time with loved ones, and tie up one’s affairs. When treated early, the average Alzheimer’s patient lives between three and 11 years, depending on age and disease progression.
While this blood test is indeed a breakthrough, medicine has a long way to go when it comes to understanding, diagnosing and treating Alzheimer’s and other forms of dementia, however. The Lumipulse blood test helps only with the detection of Alzheimer’s, not other types of dementia, such as vascular dementia.
Other conditions can cause cognitive impairments as well, including diabetes, for which the blood test wouldn’t be effective. The patient should also show cognitive symptoms; the blood test isn’t as effective for predicting Alzheimer’s before symptoms show up, as the proteins it detects may not always indicate the presence of Alzheimer’s.
Still, the blood test is highly effective. The clinical study the FDA reported in its announcement said that 92% of patients with a positive Lumipulse blood test result confirm the presence of Alzheimer’s brain plaques through PET scans or lumbar punctures.
Because it’s been cleared by the FDA, Azizi says, it’s expected to be covered by insurance plans, including Medicare.
Since Alzheimer’s disease is a common contributing factor to death for older adults, this blood test represents more time for patients to spend with their loved ones and enjoy independence.
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