Translating tumor biology into personalized treatment planning: analytical performance characteristics of the Oncotype DX Colon Cancer Assay.
Translating tumor biology into personalized treatment planning: analytical performance characteristics of the Oncotype DX Colon Cancer Assay.
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DOI：
10.1186/1471-2407-10-691
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发表时间：
2010-12-23
期刊：
影响因子：
3.8
通讯作者：
Watson D
中科院分区：
文献类型：
--
作者：
Clark-Langone KM;Sangli C;Krishnakumar J;Watson D
Oncotype DX®结肠癌检测是一种新的诊断测试，用于确定使用固定石蜡包埋(FPE)的原发结肠癌组织进行手术切除后II期结肠癌患者复发的可能性。与Oncotype DX乳腺癌检测一样，这是一种高复杂性、多分析、逆转录(RT)聚合酶链式反应(PCR)分析，可测量特定癌症相关基因的表达水平。通过捕捉每个患者肿瘤的生物学基础，Oncotype DX结肠癌检测提供了一个复发评分(RS)，反映了疾病复发的个性化风险。在这里，我们使用预先确定的性能标准来描述其分析性能，这是分子诊断测试验证的关键组成部分。所有分析测量均符合预先指定的性能标准。所有12种方法的扩增效率都很高，在96%~107%之间，所有方法的线性范围都在11log2的范围内。根据FPE RNA池的估计方差分量，分析的重复性和精密度表明，单个基因(0.16至0.32CT)、基因组(≤0.05归一化/聚合CT)和RS(≤1.38RS单位)的SD值较低。此处显示的Oncotype DX结肠癌检测中单个基因和基因组的分析性能特征表明，单个肿瘤的特定生物学一致地转化为临床有用的诊断信息。这些研究的结果表明，Oncotype DX结肠癌分析测试的分析能力如何使确定结肠癌手术后个性化复发风险的测试得到临床验证。
The Oncotype DX® Colon Cancer Assay is a new diagnostic test for determining the likelihood of recurrence in stage II colon cancer patients after surgical resection using fixed paraffin embedded (FPE) primary colon tumor tissue. Like the Oncotype DX Breast Cancer Assay, this is a high complexity, multi-analyte, reverse transcription (RT) polymerase chain reaction (PCR) assay that measures the expression levels of specific cancer-related genes. By capturing the biology underlying each patient's tumor, the Oncotype DX Colon Cancer Assay provides a Recurrence Score (RS) that reflects an individualized risk of disease recurrence. Here we describe its analytical performance using pre-determined performance criteria, which is a critical component of molecular diagnostic test validation. All analytical measurements met pre-specified performance criteria. PCR amplification efficiency for all 12 assays was high, ranging from 96% to 107%, while linearity was demonstrated over an 11 log2 concentration range for all assays. Based on estimated components of variance for FPE RNA pools, analytical reproducibility and precision demonstrated low SDs for individual genes (0.16 to 0.32 CTs), gene groups (≤0.05 normalized/aggregate CTs) and RS (≤1.38 RS units). Analytical performance characteristics shown here for both individual genes and gene groups in the Oncotype DX Colon Cancer Assay demonstrate consistent translation of specific biology of individual tumors into clinically useful diagnostic information. The results of these studies illustrate how the analytical capability of the Oncotype DX Colon Cancer Assay has enabled clinical validation of a test to determine individualized recurrence risk after colon cancer surgery.
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影响因子：
45.3
作者：
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