New FDA-approved blood tests for diagnosing Alzheimer's disease
These blood tests offer a less expensive and less invasive option for helping to diagnose Alzheimer's disease.
In May 2025, the U.S. Food and Drug Administration (FDA) approved the first blood test as a tool to help diagnose Alzheimer's disease. The test is called Lumipulse.
How does the FDA-approved blood test for Alzheimer's disease work?
The Lumipulse test uses a blood sample drawn at the doctor's office. The test measures certain proteins, including a specific form of the tau protein, that can indicate the presence of amyloid plaques in the brain. An amyloid plaque is a buildup of protein that is considered the hallmark sign of Alzheimer's disease.
This blood test, along with other diagnostic tools such as a PET scan, can help diagnose Alzheimer's disease. While the blood test can detect changes even before memory problems begin, it is recommended to only be used clinically in people who show symptoms of Alzheimer's disease.
Usually, you'll get results from the test within about 2 to 5 days.
Why is the new blood test for Alzheimer's disease important?
Previously, the only tests to detect amyloid plaques were a PET scan and lumbar puncture. In a lumbar puncture, a sample of cerebrospinal fluid (CSF) is taken from the spinal column. These tests can be expensive, and a lumbar puncture is invasive.
How accurate is the test?
Some studies have shown that the Lumipulse test is over 90% accurate in detecting Alzheimer's-related changes. However, the test is still being refined and can't diagnose Alzheimer's disease on its own. The Lumipulse test is meant to be part of an evaluation for Alzheimer's disease, including physical and medical history and imaging scans of the brain.
The accuracy rate is different between Lumipulse and other blood tests used to help diagnose Alzheimer's disease. You should discuss with your healthcare professional which test is most appropriate for you.
Who should consider taking the test?
This test is approved for adults age 50 and older who have early memory or thinking problems, such as forgetting names, misplacing things or repeating questions.
It's not yet recommended for general screening in people with no symptoms. You and your healthcare professional can decide if this test is appropriate for you.
What do the results mean?
A positive result means there are changes in your brain that may suggest Alzheimer's, but these results alone don't mean that you have the disease. Your healthcare professional may:
- Recommend more tests, such as imaging scans or tests of your memory and thinking.
- Suggest lifestyle changes to support brain health.
- Help you plan next steps, including treatment options or clinical trials.
How do I get this test?
If you and your healthcare professional decide that a blood test is appropriate for you, it can be ordered in your health professional's office.
Should I talk to my healthcare professional about this test?
Talking with your healthcare professional can help you:
- Understand what the test can (and can't) tell you.
- Decide if it's the right time for testing.
- Make a plan for what to do with the results.
You can mention it during your annual checkup or make a separate appointment.
What questions should I ask my healthcare professional?
- Do you think this test is right for me? Why or why not?
- What are the risks or downsides of getting the test?
- What would we do if the test shows signs of Alzheimer's?
- Is this test covered by insurance or an out-of-pocket expense?
- Are there other tests I should consider instead — or along with it?
How much does the new Alzheimer's blood test cost?
Cost depends on a number of factors, including where you live and lab fees. Insurance coverage varies based on your insurance carrier and plan. The cost of the test, however, is expected to be less than the costs of current options such as amyloid-PET imaging or CSF biomarker tests.
What if my healthcare professional hasn't heard about the test?
This test is still new and may not be widely offered yet. If your healthcare professional isn't familiar with it, you can ask for:
- A referral to a memory specialist or neurologist.
- A second opinion at a clinic that offers early detection or research studies.
July 08, 2025
- Palmqvist S, et al. Blood Biomarkers to Detect Alzheimer Disease in Primary Care and Secondary Care. JAMA. 2024; doi: 10.1001/jama.2024.13855.
- Barthélemy NR, et al. Highly accurate blood test for Alzheimer's disease is similar or superior to clinical cerebrospinal fluid tests. Nature Medicine. 2024; doi: 10.1038/s41591-024-02869-z
- Accurate blood test for Alzheimer's disease. National Institute on Aging. https://www.nia.nih.gov/news/accurate-blood-test-alzheimers-disease. Accessed June 19, 2025.
- Medical tests for diagnosing Alzheimer's. Alzheimer's Association. https://www.alz.org/alzheimers-dementia/diagnosis/medical_tests. Accessed June 19, 2025.
- U.S. Food and Drug Administration (FDA). FDA clears first blood test used in diagnosing Alzheimer's diseasehttps://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease. Accessed June 19, 2025.
- Hansson O, et al. The Alzheimer's Association appropriate use recommendations for blood biomarkers in Alzheimer's disease. Alzheimer's & Dementia. 2022; doi:10.1002/alz.12756.