Diagnosing Alzheimer’s disease (AD) early improves patient outcomes. Gold-standard positron emission tomography (PET) and cerebrospinal fluid (CSF) testing are invasive, expensive, and have long wait times that delay diagnosis and treatment. Blood-based biomarker tests address the lack of minimally invasive, effective, and accessible early diagnostics.1
The US Food and Drug Administration recently cleared an in vitro diagnostic blood test to aid in the detection of amyloid pathology associated with AD. The Fujirebio Lumipulse® pTau217/β-Amyloid 1-42 Plasma Ratio test is the first blood-based biomarker assay to demonstrate equivalency to PET and CSF testing. It is intended for use in individuals presenting with cognitive decline. Coupled with Fujirebio’s LUMIPULSE® G1200 automated immunoassay system, the Ratio test offers a simple, accessible, and cost-effective blood-based biomarker approach to earlier AD diagnosis.
The Lumipulse® pTau217/ß-Amyloid 1-42 Plasma Ratio test demonstrated performance levels that meet the thresholds recommended for both confirmatory and triage use, as outlined in the Clinical Practice Guideline (CPG) and the Global CEO Initiative on Alzheimer’s Disease (CEOi) consensus statement.
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Learn more about how blood-based biomarkers can improve early diagnosis of Alzheimer’s disease.
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