The first blood-based diagnostic test to aid in detecting amyloid plaques associated with Alzheimer’s disease has been cleared by the FDA.
The U.S. Food and Drug Administration (FDA) has cleared the first blood-based in vitro diagnostic device to aid in the assessment of Alzheimer’s disease. The Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio is indicated for use in adults aged 55 years and older presenting with cognitive symptoms and is designed to detect the presence of amyloid plaques—a hallmark of Alzheimer’s pathology—through analysis of plasma biomarkers.
The assay quantifies phosphorylated tau 217 (pTau217) and β-amyloid 1-42 in plasma and calculates their ratio, which correlates with the likelihood of cerebral amyloid pathology. The test is intended to supplement clinical evaluation and may reduce reliance on amyloid positron emission tomography (PET) imaging or cerebrospinal fluid (CSF) testing via lumbar puncture. Unlike CSF-based diagnostics, the plasma-based Lumipulse test requires only a venous blood draw, improving accessibility and reducing procedural burden.
The FDA’s decision was supported by a multi-center clinical study evaluating 499 plasma samples from cognitively impaired patients. The assay demonstrated 91.7% positive agreement and 97.3% negative agreement with PET or CSF reference standards. Fewer than 20% of patients received indeterminate results. The test is not intended for use as a screening tool or as a standalone diagnostic.
Potential risks include false-positive or false-negative results, which may contribute to misdiagnosis, inappropriate treatment, or delayed diagnosis. Results should be interpreted within the context of the patient’s clinical presentation and additional diagnostic workup.
The test received FDA clearance via the 510(k) premarket pathway, having demonstrated substantial equivalence to the Lumipulse G β-Amyloid Ratio (1-42/1-40), an FDA-cleared CSF-based comparator. It was also granted Breakthrough Device designation due to its potential to improve diagnostic accuracy for a progressive and debilitating condition.
Source: FDA