Genomic Health, Inc., Redwood City, CA 94063, USA.
BMC Cancer. 2010 Dec 23;10:691. doi: 10.1186/1471-2407-10-691.
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.
Oncotype DX 结肠癌检测是一种新的诊断测试，用于通过固定石蜡包埋（FPE）原发性结肠癌组织，在 II 期结肠癌患者手术后确定复发的可能性。与 Oncotype DX 乳腺癌检测一样，这是一种高复杂度、多分析物、逆转录（RT）聚合酶链反应（PCR）检测，用于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特性，Oncotype DX 结肠癌检测提供了反映疾病复发个体化风险的复发评分（RS）。在这里，我们使用预定的性能标准描述其分析性能，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定的性能标准。所有 12 项检测的 PCR 扩增效率均很高，范围在 96%至 107%之间，而所有检测的线性度均在 11 个对数 2 浓度范围内得到证明。基于 FPE RNA 池的估计方差组成，分析重复性和精密度显示单个基因（0.16 至 0.32 CT）、基因组（≤0.05 归一化/总 CT）和 RS（≤1.38 RS 单位）的低 SD。
这里显示的 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，将单个肿瘤的特定生物学特征一致地转化为临床有用的诊断信息。这些研究的结果说明了 Oncotype DX 结肠癌检测的分析能力如何使确定结肠癌手术后个体化复发风险的测试的临床验证成为可能。
