The U.S. Food and Drug Administration (FDA) has granted approval to the first blood-based test for Alzheimer’s disease, opening a new chapter in the early and accessible detection of this neurodegenerative condition.
This test works by detecting plasma biomarkers specifically, phosphorylated tau proteins (p-tau 217 or p-tau 181), which are closely associated with Alzheimer’s pathology. These proteins accumulate abnormally in the brains of individuals with Alzheimer’s, often years before the onset of symptoms. By identifying their presence in the bloodstream, the test provides a powerful early signal of potential disease activity.
Traditionally, diagnosing Alzheimer’s has required expensive and invasive procedures such as positron emission tomography (PET) scans or lumbar punctures to analyze cerebrospinal fluid. The new blood test, which only requires a simple blood draw, dramatically reduces the barrier to testing and makes early screening more feasible in outpatient, rural or primary care settings.
Medical experts believe this development will support timely diagnosis, earlier treatment planning and better enrollment into clinical trials, particularly for new disease-modifying therapies that are most effective in early stages of the disease. However, clinicians also caution that the test is not a standalone diagnostic tool. It is intended to be used as part of a broader clinical evaluation, including cognitive assessments and medical imaging when needed.
“Blood-based biomarkers are game-changers for Alzheimer’s detection. This approval brings us closer to making early diagnosis routine rather than exceptional,” said Dr. Lisa Manning, a neurologist and dementia researcher at the University of California.
The test is expected to become available in select medical centers in the coming months, with broader rollout anticipated later in the year. Healthcare providers will receive specific guidelines on how to integrate the test results into diagnostic workflows.
Disclaimer: The content provided in this article is for general informational purposes only and is not intended as a substitute for professional medical advice, diagnosis or treatment. Always seek the guidance of a qualified healthcare provider with any questions regarding Alzheimer’s disease or new diagnostic methods.
