Abstract
BackgroundThe 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.ResultsAll 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).ConclusionsAnalytical 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.
Highlights
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
When an assay result depends on multiple single-value measurements, it is imperative that the analytical characteristics of each analyte are assessed independently
We describe the analytical performance of the individual components of the Oncotype DX Colon Cancer Assay, which allowed us to confidently proceed to clinical validation
Summary
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. Achieving clinical validation for molecular tests has proven to be challenging given the dual needs for selection of high quality molecular markers and the provision of an analytically sound test process for their measurement. The clinical utility of molecular individualized treatment decision-making in early stage breast cancer [3,4,5]. Based on the results of the clinical validation study of the 12 gene Oncotype DX Colon Cancer Assay [7], stage II colon cancer patients ( those with T3 disease and mismatch repair proficient (MMR-P) tumors) are empowered to make more informed treatment decisions with quantitative, individualized recurrence risk information based on the molecular profile of their tumor
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