We are in an exciting time for Alzheimer’s disease (AD) diagnosis and treatment. In the last two years, two new medications—Kisunla and Leqembi—have become available that reduce the amyloid pathology of AD and slow down the progression of the disease. This makes obtaining a reliable diagnosis more important than ever, as these new drug therapies are highly specific to AD pathology and can only be prescribed for patients with elevated levels of amyloid in the brain.

However, getting a reliable diagnosis is sometimes easier said than done. Even when a specialist is available, a patient might need multiple medical visits and undergo specialized tests, such as a lumbar puncture or a type of brain scan called positron emission tomography (PET), to confirm the presence of abnormal brain amyloid. Adding to the challenge, these tests are both expensive and invasive. Many patients may not have the financial resources to cover the costs. Clinicians and families have long hoped for a quicker, less costly way to diagnose AD.

Now, there’s finally some good news: the Food and Drug Administration (FDA) has approved an affordable blood test to help doctors diagnose Alzheimer’s disease.

On hearing this announcement, some will say this is not new. They would be right as there have been a number of blood tests for AD available to clinicians and researchers for the last several years. However, none of those earlier blood tests were fully approved by the FDA. Consequently, none have been covered by insurance companies. With the approval of this new intravenous blood test, the FDA has opened the door for Medicare and other insurance carriers to consider covering the costs of the test. Should insurance carriers now move to cover the costs of the test, then the blood test will quickly become more available and affordable for patients everywhere.

It is important to note that using this test by itself does not allow a physician to diagnose AD. But it can be used to bolster confidence in the diagnosis and help the physician when making decisions before ordering much more expensive and invasive diagnostic tests. Furthermore, if a test should be positive for high amyloid it can help patients receive a timely diagnosis while they are in the early stages of AD and perhaps when they are still eligible to take the anti-amyloid drugs mentioned earlier, Leqembi or Kisunla.

The Alzheimer’s Association is currently working with dementia experts to develop evidence-based guidelines for the use of blood biomarker tests in clinical practice. This is something clinicians will want to help guide them through the decision-making process as to who should be tested and when should the test be ordered. These guidelines will be announced in July 27-31 at the Annual Alzheimer’s Association International Conference (AAIC) in Toronto. Until then, the Alzheimer’s Association directs providers to the 2022 guidelines for the appropriate use of blood tests in clinical practice and trial settings (Hanson et al., 2022). The Duke/UNC ADRC will be at the international conference. To learn more about the blood test, visit FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease | FDA or First Blood Test Used in Diagnosing Alzheimer’s Cleared by FDA.

Stay tuned. We will report back more as it is revealed at the AAIC meeting in Toronto.

Sources & References

Original Fujirebio Press Release: Fujirebio Receives Marketing Clearance for Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio In-Vitro Diagnostic Test As An Aid To Identify Patients With Amyloid Pathology Associated With Alzheimer’s Disease | Fujirebio).

AD Patient Newsletter: Being Patient. A great resource for patients and caregivers: The First FDA-Approved Alzheimer’s Blood Test: What You Need to Know | Being Patient

Alzheimer’s Association Statement on May 16th 2025: First Blood Test Used in Diagnosing Alzheimer’s Cleared by FDA

Appropriate use of blood tests: Hansson O, Edelmayer RM, Boxer AL, et al. The Alzheimer’s Association appropriate use recommendations for blood biomarkers in Alzheimer’s disease. Alzheimer’s Dement. 2022; 18: 2669–2686. https://doi.org/10.1002/alz.12756