Alzheimer's Association Statement on First Blood Test Used in Diagnosing Alzheimer's Disease Cleared for Use by FDA

CHICAGO, May 16, 2025 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has cleared the first blood test to aid in diagnosis of Alzheimer's disease. The test detects amyloid plaques, a hallmark of Alzheimer's disease, through a blood draw, making it less invasive than other more commonly used diagnostic tools.

"Today marks another important step in Alzheimer's disease diagnosis," said Maria C. Carrillo, Ph.D., Alzheimer's Association chief science officer and medical affairs lead. "For too long Americans have struggled to get a simple and accurate diagnosis; with today's action by the FDA we are hopeful it will be easier for more individuals to receive an accurate diagnosis earlier."

While there is no single, stand-alone test to diagnose Alzheimer's disease today — including this newly approved test — blood testing can be an important piece of the diagnostic process.  Currently, physicians primarily use other, more well-established diagnostic tools combined with medical history, neurological exams, cognitive and functional assessments, brain imaging, spinal fluid analysis — and, increasingly, blood tests — to make an accurate diagnosis and to understand which patients are eligible for approved treatments.

According to the FDA, "the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is for the early detection of amyloid plaques associated with Alzheimer's disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease."

There are a variety of laboratory-developed tests on the market that can be used to detect blood-based biomarkers associated with Alzheimer's. This is the first that has been cleared by the FDA for use. For many years, blood tests have been used in clinical trials. Increasingly, they are being used by specialists in clinical settings, often as a first pass detection tool followed by additional testing.

"Blood-based biomarkers are reshaping how we identify and understand Alzheimer's disease," continued Carrillo. "At the same time, there are important questions for health care professionals to consider; in particular, who should be tested and when."

The Alzheimer's Association is leading the development of clinical practice guidelines for the use of blood biomarker tests in specialty care settings, which will be debuted this summer at the Alzheimer's Association International Conference (AAIC), July 27-31 in Toronto and online. The first iteration of the clinical practice guidelines will provide evidence-based recommendations for specialists to help guide them through the decision-making process around who should be tested and when. In the meantime, the Association urges providers to refer to the 2022 appropriate use recommendations for blood tests in clinical practice and trial settings.

The 2025 Alzheimer's Disease Facts and Figures special report found that nearly 4 in 5 Americans would want to know if they had Alzheimer's disease before it impacted their lives. Specifically, 91% of Americans say they would want to take a simple test — such as a blood biomarker test — if it were available. Access to early treatment and care is the main reason cited for wanting a simple test.

"This interest in early diagnosis and treatment highlights how important it is that we keep advancing toward diagnostic testing that is simple to administer and widely available," Carrillo said.

This is the latest step toward better diagnosis and eventual treatment of Alzheimer's disease made possible by historic investment in Alzheimer's and dementia research by the National Institutes of Health (NIH), the Alzheimer's Association and other private entities. As a result of this increased investment, scientists have been able to work at a more rapid pace to advance basic disease knowledge, identify ways to reduce risk, uncover new biomarkers for early diagnosis and drug targeting, and develop disease-modifying treatments.

About the Alzheimer's Association
The Alzheimer's Association is a worldwide voluntary health organization dedicated to Alzheimer's care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. Visit alz.org or call 800.272.3900.

SOURCE Alzheimer's Association