FDA Endorses Groundbreaking Blood Test for Alzheimer’s Diagnosis

Introduction to the Breakthrough

U.S. health officials have given the green light to the first blood test that can aid in diagnosing Alzheimer’s disease and identifying patients who may benefit from medications designed to slow down the progression of this memory-destroying condition. The Food and Drug Administration (FDA) cleared this test for patients aged 55 and older who are exhibiting early signs of the disease.

The Significance of the Test

The test, developed by Fujirebio Diagnostics, Inc., detects a sticky brain plaque known as beta-amyloid, a key marker for Alzheimer’s. Previously, the only FDA-approved methods for detecting amyloid were invasive tests of spinal fluid or expensive PET scans. This breakthrough could significantly impact the diagnosis and treatment of Alzheimer’s, a disease that affects more than 6 million people in the United States and millions more worldwide.

How the Test Works

The new test identifies beta-amyloid in the blood, which is a significant advancement over previous methods. The lower costs and convenience of a blood test could also facilitate the use of two new drugs, Leqembi and Kisunla, which have been shown to slightly slow the progression of Alzheimer’s by clearing amyloid from the brain. Doctors are required to test patients for the plaque before prescribing these drugs, which require regular IV infusions.

Expansion of Diagnostic and Treatment Options

“Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease,” said Dr. Michelle Tarver, of FDA’s center for devices. This development is expected to expand the diagnostic and treatment options for patients, potentially leading to earlier interventions and better outcomes.

Impact on the Medical Community

A number of specialty hospitals and laboratories have already developed their own in-house tests for amyloid in recent years. However, these tests aren’t reviewed by the FDA and generally aren’t covered by insurance. The FDA clearance of this blood test brings a level of standardization and reliability to the market, which has been described as a “wild west” due to the lack of regulation and data on the accuracy of in-house tests.

Future Developments

Several larger diagnostic and drug companies, including Roche, Eli Lilly, and C2N Diagnostics, are also developing their own tests for FDA approval. This indicates a significant interest in and commitment to improving the diagnosis and treatment of Alzheimer’s disease. The tests can only be ordered by a doctor and aren’t intended for people who don’t yet have any symptoms.

By MATTHEW PERRONE

WASHINGTON (AP) — U.S. health officials on Friday endorsed the first blood test that can help diagnose Alzheimer’s and identify patients who may benefit from drugs that can modestly slow the memory-destroying disease.

The test can aid doctors in determining whether a patient’s memory problems are due to Alzheimer’s or a number of other medical conditions that can cause cognitive difficulties. The Food and Drug Administration cleared it for patients 55 and older who are showing early signs of the disease.

More than 6 million people in the United States and millions more around the world have Alzheimer’s, the most common form of dementia.

The new test, from Fujirebio Diagnostics, Inc., identifies a sticky brain plaque, known as beta-amyloid, that is a key marker for Alzheimer’s. Previously, the only FDA-approved methods for detecting amyloid were invasive tests of spinal fluid or expensive PET scans.

The lower costs and convenience of a blood test could also help expand use of two new drugs, Leqembi and Kisunla, which have been shown to slightly slow the progression of Alzheimer’s by clearing amyloid from the brain. Doctors are required to test patients for the plaque before prescribing the drugs, which require regular IV infusions.

“Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease,” said Dr. Michelle Tarver, of FDA’s center for devices.

A number of specialty hospitals and laboratories have already developed their own in-house tests for amyloid in recent years. But those tests aren’t reviewed by the FDA and generally aren’t covered by insurance. Doctors have also had little data to judge which tests are reliable and accurate, leading to an unregulated marketplace that some have called a “wild west.”

Several larger diagnostic and drug companies are also developing their own tests for FDA approval, including Roche, Eli Lilly and C2N Diagnostics.

The tests can only be ordered by a doctor and aren’t intended for people who don’t yet have any symptoms.

AP Medical Writer Lauran Neergaard contributed to this story

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

Originally Published: May 16, 2025 at 4:33 PM EDT

Conclusion

The FDA’s endorsement of the first blood test for Alzheimer’s disease is a significant step forward in the diagnosis and treatment of this condition. By providing a more accessible and less invasive method for detecting beta-amyloid, this test has the potential to improve patient outcomes and facilitate the use of new treatments.

FAQs

• Q: What is the new test for Alzheimer’s disease?
  • A: The new test is a blood test that detects beta-amyloid, a key marker for Alzheimer’s disease.
• Q: How does the test work?
  • A: The test identifies beta-amyloid in the blood, which is associated with Alzheimer’s disease.
• Q: Who can use the test?
  • A: The test is cleared for patients 55 and older who are showing early signs of Alzheimer’s disease.
• Q: What are the benefits of the test?
  • A: The test provides a less invasive and more accessible method for diagnosing Alzheimer’s, potentially leading to earlier interventions and better outcomes.
• Q: Are there any other tests for Alzheimer’s in development?
  • A: Yes, several larger diagnostic and drug companies are developing their own tests for FDA approval.