FUJIREBIO
5.3.2024 07:01:33 CET | Business Wire | Press release
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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240304661911/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Industrial Decarbonization: Calderion, WenCo and Terravent Invest in Graforce to Scale Plasma Pyrolysis Globally25.2.2026 08:07:00 CET | Press release
The investor consortium comprising the Paris-based Next Generation Fuels Industrial & Technological fund Calderion (Audacia), alongside infrastructure developer Terravent and WenCo Family Office, announces the closing of a strategic double-digit million-euro financing round for Berlin-based Graforce GmbH. The investment is dedicated to the industrial scale-up of Graforce’s proprietary plasma pyrolysis technology, addressing the growing global demand for cost-efficient low-carbon hydrogen, syngas, and carbon removal solutions that are compatible with existing industrial infrastructures. Disruptive alternative to conventional processes Graforce’s technology aims at replacing CO₂-intensive legacy routes such as steam reforming and classical gasification. By applying plasma to methane, biogas, flare gas, and landfill gas, the process converts these streams into their valuable molecular components instead of emitting them. The result is a high-efficiency production of clean hydrogen and syn
Mevion Medical Systems Announces CE Marking of the MEVION S250-FIT™ Proton Therapy System, Expanding Global Access to Compact Proton Therapy25.2.2026 08:00:00 CET | Press release
CE Marking enables marketing and clinical use of the world’s first and only LINAC vault-ready proton therapy system across the European Union Mevion Medical Systems, the global leader in compact proton therapy, today announced that the MEVION S250-FIT Proton Therapy System has successfully completed the conformity assessment process and has received CE Marking under Regulation (EU) 2017/745 (EU MDR). This regulatory milestone enables the marketing, sale, and clinical use of the MEVION S250-FIT system throughout the European Union, building on the system’s existing U.S. FDA 510(k) clearance granted in September 2025. The MEVION S250-FIT is the first and only proton therapy system designed to fit into a standard radiation therapy vault. By enabling cancer centers to use their existing infrastructure, the MEVION S250-FIT dramatically reduces the cost, complexity, and timeline traditionally associated with proton therapy adoption. This opens a new pathway for hospitals and cancer centers a
Bureau Veritas:Sector-Leading Organic Revenue Growth of 6.5% in FY 202525.2.2026 07:30:00 CET | Press release
Strong margin improvement to 16.3% in FY 2025Positive growth outlook with continued margin expansion in 2026New EUR 200 million share buyback Bureau Veritas (BOURSE:BVI): 2025 key figures1 › Full-year revenue of EUR 6,466.4 million, up 6.5% organically (with 6.3% organic growth in Q4). At constant currency, the growth was up 7.3% year-on-year and up 3.6% on a reported basis, › Adjusted operating profit of EUR 1,052.9 million, up 5.7% versus EUR 996.2 million in FY 2024, representing an adjusted operating margin of 16.3%, up 32 basis points year-on-year and up 51 basis points at constant currency, › Operating profit of EUR 992.4 million, up 6.3% versus EUR 933.4 million in FY 2024, › Adjusted net profit of EUR 631.4 million, up 1.7% versus EUR 620.7 million in FY 2024, › Adjusted EPS stood at EUR 1.42 in 2025, with a 2.8% increase versus FY 2024 (EUR 1.38 per share) and up 9.2% at constant currency, › Attributable net profit of EUR 588.0 million, up 3.3% versus EUR 569.4 million in FY 2
Galderma Announces Triple Approval of New State-of-the-Art Restylane® Syringe in the EU, the U.S., and Canada, Reaffirming the Company’s Position at the Forefront of Injectable Aesthetics25.2.2026 07:00:00 CET | Press release
Regulatory authorities in the European Union (EU), the United States (U.S.), and Canada have approved a new state-of-the-art Restylane®syringe for use with a range of Restylane NASHA® lidocaine products in multiple indications in the face and in the hands1-3 Developed in collaboration with aesthetic practitioners, its innovative ergonomic design features a cushioned finger grip and thumb rest, to improve practitioner experience through better injection comfort and control, helping them deliver consistently premium results 4-7 The syringe’s carton packaging is the first in the industry to be made from 100% recyclable paper, and reaffirms Galderma’s commitment to sustainability and environmental responsibility 8 These approvals demonstrate Galderma’s strong heritage in Injectable Aesthetics, and its commitment to continuing to drive innovation in the field Galderma (SIX: GALD), today announced that regulatory authorities in the EU, the U.S., and Canada have approved a new state-of-the-ar
Azafaros Announces Publication of Preclinical Efficacy Data with Nizubaglustat in GM2 Gangliosidosis25.2.2026 07:00:00 CET | Press release
Preclinical proof-of-concept data in GM2 gangliosidosis demonstrated survival benefit, functional improvement and target engagementResults are published in the 7 January issue of the Journal of Inherited Metabolic DiseaseNizubaglustat is currently in Phase 3 registrational studies in GM1/GM2 gangliosidoses and Niemann-Pick type C disease (NPC) Azafaros, a company aiming to become a leader in lysosomal storage disorders (LSDs), focused on addressing especially neurological symptoms, today announced the publication of proof-of-concept preclinical data with its lead product, nizubaglustat, in GM2 gangliosidosis. The data, published in the 7 January issue of the Journal of Inherited Metabolic Disease in collaboration with the laboratory of Dr. Jagdeep Walia, Department of Pediatrics, Queen's University, Kingston, Canada, reinforce nizubaglustat’s potential to address unmet needs in rare LSDs and build on existing preclinical and clinical evidence. The preclinical study tested nizubaglustat
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom