4.3 Article

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

Journal

VIRCHOWS ARCHIV
Volume 478, Issue 3, Pages 553-565

Publisher

SPRINGER
DOI: 10.1007/s00428-020-02928-z

Keywords

External quality assessment; Proficiency testing; Predictive biomarkers; Guideline; Molecular pathology; Immunohistochemistry; In situ hybridization; Oncology

Categories

Funding

  1. IQNPath

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Predictive biomarker testing is essential in personalized medicine for cancer patients, and laboratories participating in external quality assurance programs are crucial for ensuring accurate results. Recently, various EQA providers have collaborated to harmonize these programs further, emphasizing quality, transparency, and evidence-based approaches. This updated version aims to provide an overview of current practices and recommendations for predictive biomarker testing programs.
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.

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