For the first time, the U.S. Food and Drug Administration (FDA) has cleared a blood test that can help diagnose Alzheimer’s disease, potentially transforming how millions of Americans are identified and treated.
The newly approved Lumipulse test, developed by Fujirebio, detects amyloid plaques—clumps of toxic proteins that accumulate in the brains of those with Alzheimer’s. These plaques are a key hallmark of the disease, and their presence alongside memory loss or other cognitive symptoms typically confirms a diagnosis.
Until now, diagnosing Alzheimer’s relied on costly PET scans or invasive spinal taps—tools that are out of reach for many people, especially those in rural or underserved areas. “This blood test changes the game,” says Dr. Howard Fillit of the Alzheimer’s Drug Discovery Foundation. “Primary care doctors now have a faster, less invasive way to identify the disease.”
Currently, primary care physicians correctly diagnose Alzheimer’s just 60% of the time. With this new blood test, accuracy could soar above 90%, Fillit notes. Maria Carrillo of the Alzheimer’s Association agrees, adding, “This is a critical step in making early detection more accessible.”
Because it’s FDA-cleared, the Lumipulse test can now be widely marketed and used beyond large research hospitals. It’s intended for people aged 55 and older already experiencing memory problems or other symptoms of cognitive decline.
Early detection means more people could benefit from new treatments designed to slow disease progression—medications that are most effective in the earliest stages. According to a recent survey, most older adults say they would take a blood test to know if they have Alzheimer’s.
To support providers, the Alzheimer’s Association is preparing national guidelines on counseling patients about test results and treatment options. These are expected to roll out this summer.
