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
Galderma Receives U.S. FDA Approval for Differin® Epiduo® Acne Gel Prescription-to-OTC Switch22.5.2026 18:25:00 CEST | Press release
A unique Prescription-to-OTC switch in acne care, this approval expands access to a dermatologist-trusted, prescription-strength treatment for millions of acne sufferers ages 12 years and older Backed by more than 15 years of real-world dermatologist use and a robust clinical research program, this milestone demonstrates the depth of science behind the Differin® and Epiduo® heritage Adapalene plus benzoyl peroxide (0.1/2.5%) was the first FDA-approved, stable, fixed- dose prescription acne treatment to combine of benzoyl peroxide with a retinoid, and is now available over-the-counter The formulation is engineered to target multiple causes of acne more effectively than either of its individual active ingredients alone Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) us
Avanzanite Bioscience’s Partner Agios Announces PYRUKYND® (mitapivat) Approval in the European Union for Adults with Thalassaemia22.5.2026 16:18:00 CEST | Press release
Avanzanite will commercialise and distribute PYRUKYND in Europe under its exclusive agreement with Agios Avanzanite is committed to collaborating with local authorities in the EU to enable access to PYRUKYND for adult patients with thalassaemia Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassaemia, with an orphan medicinal product designation. This press release features multimedia. View the full releas
ICE Brent and ICE WTI Perpetual Futures to Launch on OKX22.5.2026 14:30:00 CEST | Press release
OKX, a blockchain technology and trading company serving more than 120 million customers globally,and Intercontinental Exchange (NYSE: ICE), one of the world's leading providers of financial market technology and data powering global capital markets including the New York Stock Exchange, today announced plans for OKX to launch perpetual futures based on ICE's Brent Crude and WTI Crude energy benchmarks. The products are expected to be available to trade on OKX’s platform in jurisdictions where OKX is licensed to offer perpetual futures products. The new OKX contracts represent a major step forward in expanding regulated access to global commodity markets through digital asset infrastructure. This first product collaboration between OKX and ICE comes after the companies established a strategic relationship in March 2026. ICE operates some of the world’s leading exchanges, clearing houses and market data services across energy, commodities, fixed income and equities markets. ICE’s future
Enhertu® Recommended for Approval in the EU by CHMP for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors22.5.2026 14:00:00 CEST | Press release
Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from patients with HER2 positive (IHC 3+) tumors in three phase 2 trials including DESTINY-PanTumor02,DESTINY-Lung01 andDESTINY-CRC02 where Enhertu demonstrated clinically meaningful responses across a broad range of tumors. The recommendation will now be reviewed by the European Commission, which has the authority
Future Health Challenge Awards USD 300,000 to Early Detection and Population Health Sensing Tools on Sidelines of World Health Assembly22.5.2026 13:45:00 CEST | Press release
Global teams recognised in the Future Health Challenge for solutions designed to detect health risks earlier and support faster health system decisions Future Health – A Global Initiative by Abu Dhabi and MIT Solve announce the winners of the inaugural Future Health ChallengeWinning solution equips frontline health workers in low-resource settings with mobile clinical decision-support tools, enabling earlier detection and more effective care deliveryTeams competed for a USD 200,000 grand prize and two USD 50,000 runner-up awards on the sidelines of the 79th World Health Assembly in GenevaWinners recognised for solutions advancing anticipatory, data-driven health systems Three global teams developing early detection and real-time population health monitoring solutions have secured a total of USD 300,000 on the sidelines of the 79th World Health Assembly. The winning solutions address critical challenges in early detection, continuous population insight and more timely decision making, s
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