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Donate NowAlzheimer’s Association Statement on FDA Clearance of PrecivityAD2 Blood Test for Alzheimer’s Diagnosis in Adults as Young as 40
“Every advance that helps people get an accurate Alzheimer’s diagnosis earlier matters,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO. “Extending clearance to adults as young as 40 recognizes that younger-onset Alzheimer’s is a reality for many families, and this test can help more of them get clarity and access to the care planning options that follow, sooner.”
This FDA action comes on the heels of additional research presented at the Alzheimer’s Association International Conference® (AAIC®) 2026 on the growing evidence base for blood-based biomarker tests in Alzheimer’s diagnosis.
The Alzheimer’s Association is committed to ensuring blood tests are used appropriately and effectively across all care settings. The Association has 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, and urges health care providers to use these guidelines in conjunction with clinical judgment.
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.
While there is no single, stand-alone test to diagnose Alzheimer’s disease today — including this newly cleared test — blood testing can be an important piece of the diagnostic process. Physicians primarily use other, more well-established diagnostic tools combined with medical history, neurological exams, cognitive and functional assessments, brain imaging and spinal fluid analysis — and, increasingly, blood tests — to make an accurate diagnosis and to understand which patients are eligible for approved 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.