A FDA-cleared blood test for Alzheimer’s disease assessment is gaining coverage as researchers highlight how blood-based biomarker (BBM) strategies can streamline amyloid pathology detection. The Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio test (Fujirebio) was cleared for use with automated immunoassay workflows to identify amyloid pathology risk in adults aged 50 and older presenting with cognitive decline in specialized care. The coverage cites PLoS One research (Qin et al., 2025) reviewing evidence that plasma markers like pTau 217 and amyloid beta 1–42 can show concordance with PET imaging and cerebrospinal fluid (CSF) biomarkers. The goal is earlier clinical decision support with less cost and invasiveness than PET or lumbar puncture. By providing high positive and negative predictive values in the cleared setting, the Plasma Ratio test is positioned as a practical lever to reduce dependence on more resource-intensive assessment pathways while supporting earlier consideration of disease-modifying therapies.
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