Gent, Belgium, Malvern PA, United States, and Tokyo, Japan, December 22nd, 2023 – H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio announced the availability of the Lumipulse G pTau 217 Plasma assay for the fully automated LUMIPULSE G immunoassay systems. This CLEIA (chemiluminescent enzyme immunoassay) assay allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma within just 35 minutes.
“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. “Expectations are high for this new biomarker, and researchers and clinical research professionals can now study its clinical utility on a platform that has the required throughput and meets the regulatory requirements to support possible future routine use.”
About pTau 217
Current research indicates that plasma pTau, including pTau 217, is a predictor of amyloid status determined either by CSF1 or PET2, and therefore able to differentiate between Alzheimer’s disease (AD) and non-AD neurodegenerative diseases3,4 and to predict progression to AD.5,6 Blood-based biomarkers, such as plasma pTau, could potentially be used as inclusion criteria or to evaluate target engagement and treatment efficacy in clinical trials, and could further advance the development and implementation of disease-modifying treatments in the field of AD and related disorders.7 This assay is designed to measure specifically the phosphorylation on position threonine 217 in human plasma.
About Fujirebio
Fujirebio, a member of H.U. Group Holdings Inc., is a global leader in the field of high-quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production, and worldwide commercialization of robust IVD products.
Fujirebio was the first company to develop and market CSF biomarkers under the Innogenetics brand over 25 years ago. Fujirebio remains the only company with such a comprehensive line-up of manual and fully automated neurodegenerative disease assays and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools. More information at Fujirebio Alzheimer. - Fujirebio's Press Release – H.U. Group's press Release [PDF] -
