FDA Approves First Blood Test to Aid Alzheimer’s Diagnosis

The U.S. Food and Drug Administration (FDA) has approved Lumipulse, the first blood test to aid in diagnosing Alzheimer's disease, a condition affecting over 7 million elderly Americans.

Lumipulse detects amyloid plaques in the brain through a blood sample, representing a less invasive and more accessible alternative to PET scans and spinal fluid tests traditionally used. Designed for patients aged 55 and older exhibiting Alzheimer’s symptoms, the test measures two specific blood plasma proteins and calculates their ratio to indicate the presence of amyloid plaques. FDA emphasizes the test's use alongside other clinical evaluations like neurological exams and cognitive assessments rather than as a standalone diagnostic tool.

Lumipulse's approval enhances potential insurance coverage and encourages wider clinical adoption, addressing limitations of earlier non-FDA-cleared blood tests. Two FDA-approved Alzheimer's drugs, Kisunla (donanemab) and Leqembi (lecanemab), require confirmation of amyloid plaques for prescription; these medications can slow disease progression but carry risks such as brain swelling and bleeding.

Experts highlight the approval as a pivotal advancement, expecting it to lower diagnosis costs, improve clinical research participation, and facilitate earlier, more accurate diagnoses. Industry leaders foresee emerging blood tests detecting other Alzheimer’s biomarkers, which could enable personalized treatment strategies akin to cancer therapies, involving biomarker characterization and targeted drug regimens. Lumipulse symbolizes the onset of a new diagnostic era for Alzheimer’s, integrating innovative biomarker tools to refine patient care and clinical trial processes.