Alzheimer's Disease Can Now Be Diagnosed with Blood Test... FDA Grants First Approval

Determining the Presence of Amyloid Plaques in the Brain

The Washington Post reported that on May 16 (local time), the U.S. Food and Drug Administration (FDA) approved a blood test for Alzheimer's disease diagnosis for the first time.

The newly approved test, called Lumipulse, measures two proteins in plasma to determine whether amyloid deposits (plaques) have formed in the brain.

The most widely accepted hypothesis is that Alzheimer's disease, a degenerative brain disorder that causes dementia, occurs when a protein called amyloid accumulates in the brain to form plaques, which then lead to the death of brain nerve cells.

Until now, Alzheimer's disease diagnosis has primarily relied on brain imaging tests such as lumbar puncture to extract cerebrospinal fluid, magnetic resonance imaging (MRI), or computed tomography (CT).

Because Lumipulse only requires a simple blood draw, it is expected to bring about a groundbreaking change in the ease of diagnosis.

This test can be administered to patients who have been admitted to specialized treatment centers after showing signs of cognitive decline. Physicians must interpret the results together with other clinical information about the patient before diagnosing Alzheimer's disease.

Since this is a blood test, it is expected to significantly reduce costs compared to existing diagnostic methods. However, Fujirebio Diagnostics, a subsidiary of Japan's HU Group and the developer of the test, has not yet disclosed the exact cost of the test.

Maria C. Carrillo, Chief Science Officer of the Alzheimer's Association in the United States, stated, "Today marks another important advance in Alzheimer's disease diagnosis," adding, "With today's FDA action, we hope more people can receive an accurate diagnosis earlier."