• Rules out Alzheimer’s disease pathology and aids in assessing other causes of cognitive decline.
• Provides a new accessible tool for timely assessment of cognitive symptoms.
• Helps primary care providers prevent unnecessary and invasive testing.
• Alzheimer’s disease diagnosis remains a multi-step process.

CHICAGO, October 13, 2025 — The U.S. Food and Drug Administration (FDA) has cleared the Elecsys pTau181 plasma test, developed by Roche. This marks the first blood-based biomarker test for Alzheimer’s disease cleared for use in the primary care setting specifically to rule out the presence of amyloid pathology.

“This is another important step toward expanding access to Alzheimer’s disease diagnostic tools,” said Joanne Pike, DrPH, Alzheimer’s Association president and chief executive officer. “At the same time, it is important to understand this test is designed to rule out the presence of amyloid plaques. It is not a test that will give an Alzheimer's disease diagnosis, nor is it a standalone tool for detection.”

According to the company, the Elecsys pTau181 blood test is intended for use in adult patients, aged 55 years and older, presenting with signs or symptoms of cognitive impairment. By providing an efficient, less-invasive method to assess the likelihood of amyloid plaques — a core hallmark of Alzheimer’s disease — this test can help primary care physicians determine which patients do not require Alzheimer’s-related follow-up tests, such as PET scans or cerebrospinal fluid analysis. This can significantly improve the diagnostic process by preventing unnecessary specialized testing for individuals whose cognitive issues stem from non-Alzheimer’s causes.

“By using a ‘rule out’ initial tool in the primary care setting, we can help people who are not living with Alzheimer’s get to the root of their cognitive symptoms faster, while ensuring those who may have the disease are referred for appropriate testing, definitive diagnosis and early treatment,” Pike continued. “This approach also empowers primary care clinicians to guide referrals more effectively, allowing specialists to focus on patients most likely to require advanced evaluation and care.”

The Alzheimer’s Association is committed to ensuring blood tests are used appropriately and effectively across all care settings. Earlier this year, the Association published clinical practice guidelines for the use of blood biomarker tests in specialty care settings, which are continually updated to reflect the evolving scientific landscape. While most data around the use of blood tests are from specialty care settings and clinical trials, we recognize these tests are being used in many settings. The Association urges providers across clinical care settings to utilize guidance on blood biomarker testing in conjunction with clinical judgement to support effective and appropriate use of these much needed tools.

The Association believes this latest development, alongside historic investment in Alzheimer’s and dementia research by the National Institutes of Health (NIH) and other entities, continues to accelerate the pace of scientific discovery, leading to better diagnostic tools and effective 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.