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    Alzheimer’s Association Statement on FDA Clearance of Elecsys pTau217 Blood Test for Alzheimer’s Diagnosis

    Alzheimer’s Association Statement on FDA Clearance of Elecsys pTau217 Blood Test for Alzheimer’s Diagnosis

    CHICAGO, Aug. 24, 2026 — The U.S. Food and Drug Administration (FDA) has cleared the Elecsys pTau217 plasma test (Roche Diagnostics) for use in diagnosing Alzheimer’s disease in patients presenting with signs or symptoms of cognitive impairment. The test was cleared as a single-biomarker tool to support both rule-in and rule-out assessment of amyloid pathology in primary and specialty care settings. This is the fourth blood-based biomarker test for Alzheimer’s disease cleared by the FDA — the second in the past week — continuing the field’s progress toward more accessible diagnostic tools.

    “This is the latest advancement in Alzheimer’s research, making an accurate diagnosis and the treatment and care management options that can follow, more accessible,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO.

    As more blood-based tests become available, the Alzheimer’s Association continues to help health care providers put them to appropriate use. The Association’s clinical practice guidelines on blood biomarker testing are updated as new evidence emerges and are meant to be used in conjunction with a clinician's judgment.

    “Each FDA clearance gives clinicians another validated option to work with when evaluating patients showing signs of cognitive impairment,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer and medical affairs lead. “That’s real progress for a field that, for decades, had far too few tools to offer.”

    Momentum like this doesn’t happen overnight. It reflects more than a decade of sustained investment in Alzheimer’s and dementia research — from public funding through the National Institutes of Health (NIH) to private investment in diagnostics and drug development. That combined investment is what continues to turn scientific discovery into real options for people and their families.

    While no single test can diagnose Alzheimer’s disease on its own, used alongside a standard clinical evaluation, blood tests like this one can help people get answers faster. For many families, long wait times for a diagnosis are one of the hardest parts of the process, and faster answers mean faster access to care planning and, where appropriate, treatment.

    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.