Fujirebio has announced that its subsidiary, Fujirebio Diagnostics, Inc., has submitted the Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test to the U.S. Food and Drug Administration (FDA) for approval. This new plasma test is poised to become the first commercially available blood-based IVD test in the U.S. for aiding in the assessment of Alzheimer’s disease (AD). The test, which received Breakthrough Device Designation from the FDA, measures the concentrations of pTau 217 and β-Amyloid 1-42 in human plasma. These values are combined into a numerical ratio to detect amyloid pathology, a hallmark of AD linked to cognitive decline.
Alzheimer’s disease affects more than 6 million people in the U.S. and is a leading cause of disability and death. Currently, diagnostic tools are limited, often involving subjective assessments or expensive and invasive procedures like amyloid PET scans or cerebral spinal fluid (CSF) testing. Consequently, many patients receive a diagnosis only after the disease has progressed, reducing the effectiveness of available treatments.
The Lumipulse pTau 217/β-Amyloid 1-42 Plasma Ratio test is designed to be used with Fujirebio’s fully automated Lumipulse G1200 instrument system, commonly found in U.S. clinical labs. It complements the Lumipulse G β-Amyloid Ratio (1-42/1-40) test, which was FDA-approved for CSF testing in May 2022.
Monte Wiltse, President and CEO of Fujirebio Diagnostics, Inc., stated, “The lack of accessible diagnostics for Alzheimer’s leads to late diagnosis and inadequate treatment. Our Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test aims to help physicians diagnose AD much earlier, at a stage where interventions can be more effective. Early and accurate diagnosis will also aid in the development of new therapies, which are urgently needed as Alzheimer’s prevalence rises with the aging global population. Fujirebio remains committed to expanding diagnostic tools for AD and improving treatment outcomes.
