Use of a new blood test (Lumipulse} to detect this disease is poised to become the standard of care, accelerating diagnosis and the path to treatment. The ability to diagnose Alzheimer’s disease simply and cost-effectively took a major step forward in May 2025, when the FDA approved the first blood test for early detection of this condition. It’s intended for people aged 55 or older with signs or symptoms suggestive of the disease. The test, called Lumipulse, isn’t the only one of its kind detect Alzheimer’s blood markers. But it’s the only one that has made it through the rigorous regulatory approval process, a milestone that’s considered a game changer. At present, a blood test and a brain MRI are just two objective components involved in making an Alzheimer’s diagnosis. Although there are presently a number of accurate Alzheimer’s blood tests available for clinical use, and some of these blood tests have been marketed directly to consumers. But without FDA approval and safety regulation, they have not been part of the standard of care for diagnosis—they’ve just been novel tests that people could pay for out of their own pocket, and such testing might cost between $300 and $1,750 from some companies. Instead, two other, more complicated, invasive, and costly types of FDA-approved tests are available and covered by insurance to confirm the presence of Alzheimer’s: a positron emission tomography (PET) scan of the brain and a lumbar puncture, or “spinal tap,” which can detect disease biomarkers from a sample of fluid surrounding the brain and spinal cord. Now, however, the FDA approval of Lumipulse changes things, because this approval means that the blood test has been evaluated by scientists, and is doing what it claims, increasing its potential to be beneficial for patient care. The next step is for insurance to consider covering it, particularly Medicare and Medicaid. If that happens, which is expected soon, the test will likely become the standard of care. We’ll have a pathway for the rapid detection of Alzheimer’s, which will allow the early beginning of start treatment.
The test analyzes a blood sample to look for several proteins that are characteristic of Alzheimer’s disease. It calculates the ratio of a amyloid beta 40 (which is naturally present in the brain and considered normal) to amyloid-beta 42 (which is involved in forming Alzheimer’s brain plaques). The test also detects a type of tau protein (phosphorylated tau 217) that causes tangles in brain cells. About 80% of the time, the blood test is either highly positive or highly negative, a result that’s accurate more than 90% of the time. But about 20% of the time, the test is inconclusive.
How physicians might use Lumipulse, especially when it is covered by insurance. First, the primary care provider identifies a patient with memory complaints and cognitive impairment as determined by a sensitive but brief cognitive screening test. The patient has blood tests to look for vitamin deficiencies and thyroid disorders and possibly an MRI scan to look for brain tumors, fluid collections, and other structural problems. If these tests do not provide answers, the doctor then can order this approved blood test to look for Alzheimer’s markers. In that scenario, If the blood test is clearly negative, the patient is told the reassuring news but also told that his/her memory problems will be readdressed in six months. Nevertheless, If something is clearly wrong, the patient can be referred to a memory specialist to look for other causes of dementia. If the test is inconclusive, the patient may be referred to a memory specialist for either an amyloid PET scan or a lumbar puncture to determine the correct diagnosis. If, on the other hand, the blood test comes back positive, the patient is best referred directly to a neurologist or another specialist for treatment with an amyloid-targeting therapy—donanemab (Kisunla) or lecanemab (Leqembi). These medicines remove amyloid plaques from the brain, hopefully before too much damage is done. They’re not a cure, but they slow the disease process. And studies show that the earlier one intervenes with treatment for someone with symptomatic Alzheimer’s in early stages, the more effective the medications will be.
The likelihood that other blood tests for Alzheimer’s will be approved: Several other tests will probably gain FDA approval. Because we have disease-modifying treatments for Alzheimer’s disease, there is now an imperative to detect and treat these patients quickly. Just like in a patient in whom cancer is detected, the treatment is best begun within two months or earlier. Blood-based biomarkers will be crucial to help make this scenario into a reality.
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