FDA Clears Lumipulse as First Blood Test for Diagnosing Alzheimer Disease

MIAMI - EntSun -- The FDA cleared Fujirebio's Lumipulse Plasma Ratio blood test for the early detection of amyloid plaques associated with Alzheimer's disease (AD). Lumipulse is the first in-vitro diagnostic (IVD) test used in the diagnosis of AD.

NeurologyLive wrote that the test operates on the Lumipulse G platform, a fully automated system that uses chemiluminescent enzyme immunoassay technology to quantify biomarkers with high sensitivity and precision. The p-tau217 protein, associated with neurofibrillary tangles in AD, and ß-Amyloid 1-42, which forms amyloid plaques, are measured in plasma using the Lumipulse G p-tau217/ß-Amyloid 1-42 Plasma Ratio to distinguish amyloid-positive individuals from amyloid-negative ones, giving patients a non-invasive alternative for early AD detection.

A pivotal study involving nearly 500 individuals with mild cognitive impairment (MCI), published in Fluids and Barriers of the CNS in 2025, played a key role in the FDA's decision to clear the blood test. The findings showed that 91.7% of participants who tested positive with the blood test also had confirmed amyloid plaques based on PET scans or cerebrospinal fluid (CSF) analysis. Similarly, 97.3% of those who tested negative showed no signs of amyloid buildup on follow-up PET or CSF tests, demonstrating the test's high level of accuracy and reliability.

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Dr. Jeff Gelblum, one of the nation's leading treaters of Alzheimer's disease, believes that this new FDA approval will offer greater capability to diagnose and treat Alzheimer's. He observes that "confirmatory brain PET scans are prohibitively costly to many patients and often not approved by insurance companies. Alternatively, spinal taps are invasive, require a prolonged office setting, and are off-putting to many folks. This new blood test is a convenient, accessible, readily available diagnostic tool." Moreover, he believes that this test offers primary care providers the opportunity to confirm a suspected Alzheimer's diagnosis and expedite patient referral to specialized treatment centers such as Gelblum's.

Alzheimer's disease currently impacts approximately 7 million people in the United States, with projections estimating that number will grow to nearly 13 million by 2060. As one of the leading causes of disability and death among older adults, Alzheimer's progresses gradually over many years, often without noticeable symptoms in its early stages. Unfortunately, the absence of easily accessible and minimally invasive diagnostic tools has meant that many individuals go undiagnosed until the disease is significantly advanced.

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"Nearly 7 million Americans are living with Alzheimer's disease, and this number is projected to rise to nearly 13 million," said Michelle Tarver, MD, PhD, director of the FDA's Center for Devices and Radiological Health. "Today's clearance is an important step for Alzheimer's diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease."

For additional information about Alzheimer's disease, visit fcneurology.net