Blood-based biomarker testing is expanding access to Alzheimer’s disease assessment following FDA clearance of a new automated plasma ratio test. Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio received FDA clearance, aimed at adults aged 50 and older presenting to specialized care settings with symptoms of cognitive decline. The test is intended to streamline assessment of amyloid pathology with a simple blood draw, reducing reliance on more invasive CSF sampling or costly PET imaging. The Plasma Ratio is an automated immunoassay designed to estimate the likelihood of underlying amyloid pathology with high positive and negative predictive values. The discussion is supported by literature cited in PLoS One (Qin et al., 2025;20(12):e0338018), which aligns plasma biomarkers such as pTau 217 and Aβ42 with PET and CSF findings. The broader clinical context is earlier identification of amyloid pathology to inform referral and potential use of disease-modifying therapies. For biotech and diagnostics, the clearance reinforces the trajectory toward scalable, routine-friendly amyloid assessment in memory-care workflows, potentially changing how patients are routed for confirmatory testing and treatment decisions.
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