FDA Clears First Blood Test for Diagnosing Alzheimer’s

On May 16, 2025, the U.S. Food and Drug Administration (FDA) granted clearance for the first blood test designed to aid in diagnosing Alzheimer’s disease. Developed by Fujirebio Diagnostics, the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test detects two key biomarkers—pTau217 and beta-amyloid 1-42—associated with the formation of amyloid plaques in the brain, a hallmark of Alzheimer’s. This test offers a less invasive and more accessible alternative to traditional diagnostic methods like PET scans and spinal taps.

Approved for individuals aged 55 and older exhibiting signs of cognitive decline, the Lumipulse test demonstrated approximately 92% accuracy in detecting Alzheimer’s and over 97% accuracy in ruling it out in clinical studies involving 499 cognitively impaired patients.  While not intended for general population screening, it serves as a valuable tool in the diagnostic process when used alongside other assessments. 

The FDA's clearance of this test is seen as a significant advancement in improving early diagnosis and treatment access for the nearly 7 million Americans currently living with Alzheimer’s—a number projected to rise to 13 million by 2050.