GENT, Belgium & MALVERN, Pa. & TOKYO--(BUSINESS WIRE)--H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G ApoE4 and Lumipulse G Pan-ApoE assays for the fully automated LUMIPULSE® G Systems. These CLEIA (chemiluminescent enzyme immunoassay) assays allow for the quantitative measurement of the E4 isoform of the apolipoprotein E (ApoE4), specifically, and for all isoforms of the same protein (Pan-ApoE), respectively, in human plasma within just 35 minutes. The two new automated blood-based biomarker assays are available for Research Use Only.
“One year after the release of the first blood-based biomarkers for Alzheimer’s disease on our robust LUMIPULSE G platform, Fujirebio adds another two markers to its steadily growing portfolio,” said Christiaan De Wilde, CEO of Fujirebio Europe NV and Global Head Neuro Business. “These new assays will further support biomarker research in the field of neurodegenerative diseases, an important mission for Fujirebio.”
The Lumipulse G ApoE4 and the Lumipulse G Pan-ApoE assays complement the blood-based biomarker panel of RUO assays for β-amyloid1-42, β-amyloid1-40, phospho-Tau181 and neurofilament light, alongside five cerebrospinal fluid (CSF) based assays (β-amyloid1-42, β-amyloid1-40, total Tau, phospho-Tau181 and neurofilament light; all CE-IVDR, except for the latter) already available within the Lumipulse G Neuro product portfolio.
They will allow researchers and clinical research professionals across the world to further investigate the clinical utility of the ApoE protein quantification in Alzheimer’s disease and related disorders on the LUMIPULSE G platform. This platform has the required throughput and meets the regulatory requirements to support possible future routine use of blood-based testing of these markers. The APOE gene has three different alleles (ε2, ε3, ε4) that encode for three different ApoE isoforms (ApoE2, ApoE3, and ApoE4), resulting in 6 different phenotypes1. Molecular testing remains the gold standard for APOE genotyping, however quantification of the ApoE proteins using immunoassays could provide another piece of information, related to the expression levels of the proteins coded in the genes. There is hope that blood-based testing can become an even simpler, more accessible, and more scalable approach to help support the diagnosis of Alzheimer’s disease. In this regard, ApoE as a protein biomarker can be used in research to determine its value alone or as part of a panel of plasma biomarkers2.
The development of the Lumipulse G ApoE4 and Lumipulse G Pan-ApoE assays has been supported by the Flanders Innovation & Entrepreneurship (VLAIO).
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 AD 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 can be found at www.fujirebio.com/alzheimer.