Fujirebio, a subsidiary of H.U. Group Holdings Inc., has announced the commercial availability of its Lumipulse G pTau 217 Plasma assay, marking a significant advancement in blood-based biomarker testing for Alzheimer's disease research. The fully automated chemiluminescent enzyme immunoassay (CLEIA) enables quantitative measurement of tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma samples within just 35 minutes.
Clinical Significance of pTau 217
Current research demonstrates that plasma pTau 217 serves as a predictor of amyloid status, traditionally determined through cerebrospinal fluid (CSF) analysis or positron emission tomography (PET) imaging. The biomarker shows promise in differentiating between Alzheimer's disease and non-Alzheimer's neurodegenerative diseases, while also predicting disease progression to Alzheimer's.
The assay specifically measures phosphorylation at position threonine 217 in human plasma, offering researchers a less invasive alternative to current diagnostic methods. Blood-based biomarkers like plasma pTau could potentially serve as inclusion criteria for clinical trials or evaluate target engagement and treatment efficacy, potentially accelerating the development of disease-modifying treatments for Alzheimer's disease and related disorders.
Platform Integration and Automation
The new assay integrates with Fujirebio's established LUMIPULSE G immunoassay systems, providing the throughput and regulatory compliance necessary for potential future routine clinical use. This automation capability addresses a critical need in neurodegenerative disease research, where high-throughput, standardized testing platforms are essential for large-scale studies.
"The launch of the pTau 217 Plasma assay on our fully automated LUMIPULSE platform is an essential step in the efforts of Fujirebio to bring novel, innovative neurodegenerative biomarkers to laboratories and clinicians around the world," said Goki Ishikawa, President and CEO of Fujirebio Holdings, Inc.
Company Background and Market Position
Fujirebio brings over 50 years of experience in in vitro diagnostics development and commercialization to this launch. The company pioneered CSF biomarker development and marketing under the Innogenetics brand over 25 years ago, establishing itself as the only company with a comprehensive portfolio of both manual and fully automated neurodegenerative disease assays.
The company continues to partner with clinical experts worldwide to develop diagnostic pathways that enable earlier, more accessible, and comprehensive neurodegenerative disease testing. This latest addition to their Alzheimer's disease test menu reinforces their commitment to advancing the field through innovative biomarker solutions.
Ishikawa noted that expectations are high for this new biomarker, emphasizing that researchers and clinical research professionals can now study its clinical utility on a platform designed to meet the demanding requirements of both current research and potential future routine clinical applications.
