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首页> 外文期刊>The Journal of molecular diagnostics: JMD >Three Rounds of External Quality Assessment in France to Evaluate the Performance of 28 Platforms for Multiparametric Molecular Testing in Metastatic Colorectal and Non-Small Cell Lung Cancer
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Three Rounds of External Quality Assessment in France to Evaluate the Performance of 28 Platforms for Multiparametric Molecular Testing in Metastatic Colorectal and Non-Small Cell Lung Cancer

机译：法国进行了三轮外部质量评估，以评估28种多参数分子测试平台在转移性结直肠癌和非小细胞肺癌中的性能

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摘要

Personalized medicine has gained increasing importance in clinical oncology, and several clinically important biomarkers are implemented in routine practice. In an effort to guarantee high quality of molecular testing in France, three subsequent external quality assessment rounds were organized at the initiative of the National Cancer Institute between 2012 and 2014. The schemes included clinically relevant biomarkers for metastatic colorectal (KRAS, NRAS, BRAF, PIK3CA, microsatellite instability) and non-small cell lung cancer (EGFR, KRAS, BRAF, PIK3CA, ERBB2), and they represent the first multigene/multicancer studies throughout Europe. In total, 56 laboratories coordinated by 28 regional molecular centers participated in the schemes. Laboratories received formalin-fixed, paraffin-embedded samples and were asked to use routine methods for molecular testing to predict patient response to targeted therapies. They were encouraged to return results within 14 calendar days after sample receipt. Both genotyping and reporting were evaluated separately. During the three external quality assessment rounds, mean genotype scores were all above the preset standard of 90% for all biomarkers. Participants were mainly challenged in case of rare insertions or deletions. Assessment of the written reports showed substantial progress between the external quality assessment schemes on multiple criteria. Several essential elements such as the clinical interpretation of test results and the reason for testing still require improvement by continued external quality assessment education.
机译：个性化医学已在临床肿瘤学中变得越来越重要，并且在常规实践中采用了几种临床上重要的生物标志物。为了确保法国分子检测的高质量，2012年至2014年，在国家癌症研究所的倡议下，组织了三轮后续的外部质量评估。这些方案包括转移性结直肠癌的临床相关生物标志物（KRAS，NRAS，BRAF， PIK3CA，微卫星不稳定性）和非小细胞肺癌（EGFR，KRAS，BRAF，PIK3CA，ERBB2），它们代表了整个欧洲的首个多基因/多癌研究。总共有28个区域分子中心协调的56个实验室参加了该计划。实验室收到了福尔马林固定，石蜡包埋的样品，并被要求使用常规的分子检测方法来预测患者对靶向疗法的反应。鼓励他们在收到样品后的14个日历日内返回结果。基因分型和报告都分别进行了评估。在三个外部质量评估回合中，所有生物标记的平均基因型得分均高于90％的预设标准。参加者主要是在罕见的插入或缺失的情况下受到挑战。对书面报告的评估显示，在多个标准的外部质量评估计划之间，取得了实质性进展。通过持续的外部质量评估教育，仍然需要改进一些基本要素，例如测试结果的临床解释和测试的原因。

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