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.

在个性化医疗中，预测性生物标志物测试是为癌症患者选择适当治疗的基础。实验室确保准确结果的一个重要工具是参与外部质量保证 (EQA) 计划。一些供应商为不同的癌症类型、测试方法和样本类型提供预测性 EQA 程序。2013 年，发布了关于组织高质量分子病理学 EQA 项目要求的指南。现在，六年后，IQNPath ABSL 采取了进一步协调这些 EQA 计划的举措，IQNPath ABSL 是一个由各种 EQA 供应商创立的伞式组织。本次修订基于现有知识，增加了对通过原位方法（免疫组织化学和原位杂交）为预测性生物标志物开发的程序的建议，并强调透明度和基于证据的方法。此外，此更新版本还旨在概述各种 EQA 提供商的当前做法。