Fujirebio Europe NV

GENT, Belgium & AMSTERDAM--( BUSINESS WIRE )--Fujirebio Europe and Self-screen B.V. today announced an expansion of their commercial collaboration with the distribution of the PreCursor-M AnoGYN methylation-specific molecular assay from Self-screen B.V. The test is intended for the detection of promoter hypermethylation of the genes ASCL1 and ZNF582 and is used to test the methylations status of anal specimens for research use only (RUO). It complements Fujirebio's HPV-associated molecular test portfolio. “The Human Papilloma Virus (HPV) test panel of Fujirebio Europe continues to grow with effective and accurate testing solutions, and we are pleased to add this new RUO methylation-based assay to our molecular testing toolbox,” says Christiaan De Wilde, CEO at Fujirebio Europe “With its unmatched accuracy and reliability, this innovative PreCursor-M AnoGYN assay represents a significant advancement for research studies in the field of anal cancer prevention. We wanted our customers to have access to this valuable research tool as soon as possible, ultimately catalyzing advancements in elimination of HPV-related diseases.” “ We are very happy with the continued partnership with Fujirebio in the distribution of Self-screen’s HPV tests and methylation tests, ” says Michelle Meijer, Chief Commercial Officer at Self-screen B.V. “ The PreCursor-M AnoGYN extends our offering of HPV products into the field of anal cancer. Also in this HPV-related cancer, methylation appears to be promising for future use as an accurate biomarker for objective risk stratification of anal lesions. The growing medical need for better and more supportive diagnostics tools for HPV related cancers such as anal cancer drove us to the development of the PreCursor-M AnoGYN RUO assay which is now available through Fujirebio.” About host cell DNA methylation and anal cancer Incidence of anal cancer is increasing worldwide. The majority of anal cancers are squamous cell carcinoma (SCC) and are, like cervical cancer, mainly caused by a persistent high-risk HPV infection and preceded by high-grade squamous intraepithelial lesion (HSIL). In analogy with cervical cancer screening, the screening and treatment of HSIL to prevent anal cancer in high-risk groups are under debate. Host cell DNA methylation is an epigenetic hallmark of HPV-induced carcinogenesis. The PreCursor-M AnoGYN assay is a robust and reliable tool to further investigate host cell DNA methylation in anal carcinogenesis and study its potential as a valuable biomarker for the detection of anal (pre-)cancer. 1-4 Please contact Fujirebio for further information about the local availability of the test. About Self-screen B.V. Self-screen B.V. is a company highly experienced in translational HPV related research, assay development and commercialization of In Vitro Diagnostics (IVD). Our dedication is towards the development and clinical application of molecular assays for the early detection of anogenital and head & neck (pre)cancers, to the benefit of patients and health care programs around the world. Our main focus is on cervical (pre)cancer screening and prevention. Self-screen markets two clinically validated CE-IVD assays. The HPV-Risk-Assay and the PreCursor-M+ Methylation Test, for screening and triage respectively, to support full molecular cervical screening and to assist the clinician in management of women with high-grade CIN. Recently PreCursor-M AnoGYN RUO is added. For more information, visit www.self-screen.nl . About Fujirebio Fujirebio is a global leader in the field of high-quality IVD testing. We have more than 50 years’ accumulated experience in the conception, development, production, and worldwide commercialization of robust IVD products. Fujirebio has a long-lasting tradition for developing high-quality routine and truly novel biomarkers. Our IVD product lines span the range from specialized manual and automated testing to fully automated routine clinical laboratory testing solutions covering a variety of disease states. Our global presence includes offices in the United States, Latin America, Europe and Asia as well as a vast international distribution network. For more information, visit www.fujirebio.com . References: van der Zee R.P. , et al. Host cell deoxyribonucleic acid methylation markers for the detection of high-grade anal intraepithelial neoplasia and anal cancer. Clin. Infect. Dis., 68 (7); 1110-1117, 2019 van der Zee R.P. , et al. Cancer risk stratification of anal intraepithelial neoplasia in human immunodeficiency virus-positive men by validated methylation markers associated with progression to cancer. Clin. Infect. Dis., 72 (12); 2154-2163, 2021 van der Zee R.P. , et al. DNA methylation markers have universal prognostic value for anal cancer risk in HIV-negative and HIV-positive individuals. Mol. Oncol., 15 (11); 3024-3036, 2021, 2021 Rozemeijer K, et al . Analytical validation and diagnostic performance of the ASCL1 / ZNF582 methylation test for detection of high-grade anal intraepithelial neoplasia and anal cancer. Tumour Virus Res. 30;17:200275, 2023

The Lumipulse G ApoE4 and the Lumipulse G Pan-ApoE assays are expected to enable researchers to further assess the clinical utility of the quantification of the ApoE protein in Alzheimer’s disease and related disorders on the platform The two new assays are said to further extend the fully automated blood-based biomarker portfolio of Fujirebio. (Credit: CDC on Unsplash) In vitro diagnostics products maker Fujirebio has launched the Lumipulse G ApoE4 and Lumipulse G Pan-ApoE assays for research use only (RUO) for the fully automated LUMIPULSE G Systems. The H.U. Group subsidiary has designed the chemiluminescent enzyme immunoassay (CLEIA) assays to enable 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 under 35 minutes. Fujirebio said that the two new assays further extend its fully automated blood-based biomarker portfolio. Fujirebio Europe CEO and neuro business global head Christiaan De Wilde said: “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. “These new assays will further support biomarker research in the field of neurodegenerative diseases, an important mission for Fujirebio.” Both assays complement the blood-based biomarker panel of RUO assays for β-amyloid1-42, β-amyloid1-40, phospho-Tau181 and neurofilament light, along with five already available cerebrospinal fluid (CSF)-based assays of the Lumipulse G Neuro product range. Fujirebio said that the Lumipulse G ApoE4 and the Lumipulse G Pan-ApoE assays will enable researchers to further assess the clinical utility of the quantification of the ApoE protein in Alzheimer’s disease and related disorders on the LUMIPULSE G platform. The platform has the necessary throughput and matches the regulatory needs to support potential future use of blood-based testing of these markers, the in vitro diagnostics products maker added. Last month, Fujirebio and its fully-owned subsidiary Fujirebio Diagnostics entered into a partnership with South Korea-based AriBio to advance the development of biomarkers for Alzheimer’s and other neurodegenerative conditions.

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). 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 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 . References: Emi M, et al. Genomics, 3(4):373-379, 1988. Palmqvist S, et al. Nat Med, 27(6):1034-1042, 2021. View source version on businesswire.com: Contacts For media: Public Relations Section, Public Relations/Sustainability Department, H.U. Group Holdings, Inc.. Phone: +81-3-6279-0884 E-mail: pr@hugp.com Christiaan De Wilde CEO Fujirebio Europe Phone: +32 9329 1703 For investors and analysts: IR/SR Dept. Phone: +81-3-5909-3337 E-mail: ir@hugp.com Source: FUJIREBIO EUROPE View this news release online at: