Traditional Diagnostic Methods of Alzheimer’s Disease and Evaluation of Alzheimer’s Diagnosis with Blood Tests

Research Article

Abstract

This article introduces traditional diagnostic methods for Alzheimer’s disease and the assessment of Alzheimer’s diagnosis with blood tests.
A significant step towards making Alzheimer’s disease easily and affordably diagnosable was taken in May 2025 when the FDA approved the first blood test for early diagnosis of the disease. This test is designed for people 55 years and older who are showing signs or symptoms of the disease.
This new blood test, called Lumipulse, is not the only one of its kind that looks for Alzheimer’s blood markers. However, being the only test to have passed the rigorous regulatory approval process is considered a groundbreaking development.
To learn about the significance of this development and what it could mean for Alzheimer’s diagnosis: A number of accurate Alzheimer’s blood tests are available for clinical use, and some blood tests have been offered directly to consumers. However, without FDA approval, FDA safety regulations, and public and private insurance coverage, the tests have not been part of standard care for diagnosis; they have simply been new tests that people could pay for out of pocket. For example, the cost of the test can range from $300 to $1750 in some companies. Sometimes financial aid is also available. Instead, we relied on two more complex, invasive, and costly types of FDA-approved tests that are covered by insurance to confirm the presence of Alzheimer’s disease: a positron emission tomography (PET) scan of the brain and a lumbar puncture or “spinal tap,” which can detect disease biomarkers in a sample of fluid surrounding the brain and spinal cord.
Approval means the blood test has been evaluated by scientists, that it fulfills its claimed function, and that it has the potential to be beneficial in people’s care.
The next step is for insurance companies to consider covering it. If this happens, which is expected to happen soon, the test will likely become standard care.
Approval means the blood test has been evaluated by scientists, that it fulfills its claimed function, and that it has the potential to be beneficial in people’s care.
The next step is for social security, in particular, to consider covering the cost of these tests. This is expected to happen, and it will happen soon. If it does, the test will likely become standard care. We will have a way to quickly detect Alzheimer’s disease, which will allow us to start treatment immediately. [1-3].