학술논문
Biomarker testing in oncology - Requirements for organizing external quality assessment programs to improve the performance of laboratory testing: revision of an expert opinion paper on behalf of IQNPath ABSL.
Document Type
Academic Journal
Author
Dufraing K; Biomedical Quality Assurance Research Unit, Department of Public Health and Primary Care, KU Leuven, Kapucijnenvoer 35 blok d, 3000, Leuven, Belgium.; Fenizia F; Cell Biology and Biotherapy Unit, Istituto Nazionale Tumori 'Fondazione G. Pascale'-IRCCS, Naples, Italy.; Torlakovic E; Department of Pathology and Laboratory Medicine, Royal University Hospital, College of Medicine, University of Saskatchewan and Saskatchewan Health Authority, Saskatoon, Saskatchewan, Canada.; Wolstenholme N; European Molecular Quality Network (EMQN), Manchester Centre for Genomic Medicine, St Mary's Hospital, Manchester, M13 9WL, UK.; Deans ZC; UK NEQAS for Molecular Genetics, Department of Laboratory Medicine, Royal Infirmary of Edinburgh, Little France Crescent, Edinburgh, EH16 4SA, UK.; Rouleau E; Department of Medical Biology and Pathology, Gustave Roussy, Cancer Genetics Laboratory, Gustave Roussy, Villejuif, France.; Vyberg M; NordiQC, Institute of Pathology, Aalborg University Hospital, Aalborg, Denmark.; Parry S; UK NEQAS ICC & ISH, University College London Cancer Institute, London, UK.; Schuuring E; Department of Pathology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, PO Box 30001, 9700, RB, Groningen, The Netherlands.; Dequeker EMC; Biomedical Quality Assurance Research Unit, Department of Public Health and Primary Care, KU Leuven, Kapucijnenvoer 35 blok d, 3000, Leuven, Belgium. els.dequeker@kuleuven.be.
Source
Publisher: Springer International Country of Publication: Germany NLM ID: 9423843 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-2307 (Electronic) Linking ISSN: 09456317 NLM ISO Abbreviation: Virchows Arch Subsets: MEDLINE
Subject
Language
English
Abstract
In personalized medicine, predictive biomarker testing is the basis for an appropriate choice of therapy for patients with cancer. An important tool for laboratories to ensure accurate results is participation in external quality assurance (EQA) programs. Several providers offer predictive EQA programs for different cancer types, test methods, and sample types. In 2013, a guideline was published on the requirements for organizing high-quality EQA programs in molecular pathology. Now, after six years, steps were taken to further harmonize these EQA programs as an initiative by IQNPath ABSL, an umbrella organization founded by various EQA providers. This revision is based on current knowledge, adds recommendations for programs developed for predictive biomarkers by in situ methodologies (immunohistochemistry and in situ hybridization), and emphasized transparency and an evidence-based approach. In addition, this updated version also has the aim to give an overview of current practices from various EQA providers.