FDA Approves First Blood Test to Diagnose Alzheimer’s Disease

The U.S. Food and Drug Administration (FDA) has approved the Lumipulse test by Fujirebio Diagnostics, the first blood-based diagnostic tool cleared for detecting Alzheimer’s disease. It’ll be available in late June.

Alzheimer’s is a progressive neurologic disorder where early and accurate diagnosis is key for timely intervention and management. The Lumipulse test detects amyloid plaques—abnormal clumps of protein in the brain—by measuring the levels of two specific proteins. Clinical studies show the test is highly accurate and it offers a less invasive alternative to traditional methods.

The approval of Lumipulse is expected to enhance access to Alzheimer’s diagnosis and treatment, and lower testing costs for patients.

While the Lumipulse test offers key advancements, it’s important to note that a positive result doesn’t confirm Alzheimer’s disease. Other conditions can also present amyloid plaques, and some individuals with plaques may never develop symptoms. Patients should visit their primary care doctor or neurologist to be evaluated for Alzheimer’s disease, and determine an appropriate treatment plan if needed.