Translating tumor biology into personalized treatment planning: analytical performance characteristics of the Oncotype DX？ Colon Cancer Assay

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.The emergence of personalized medicine as a central healthcare theme has led to an explosion of research dedicated to finding molecular markers for prediction of disease outcome and treatment benefit. However, 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. Indeed, the clinical utility of molecular biomarkers may be limited unless they are provided in the context of a robust, well-characterized diagnostic test with documented accuracy, precision, and reproducibility. The Oncotype DX Breast Cancer Assay has met this standard as an analytically and clinically validated high complexity, multi-analyte, RT-PCR test to predict the likelihood of recurrence and response to chemotherapy in estrogen receptor-positive, node-negative and node-positive breast cancer patients [1,2]. With over 160,000 tests performed since its launch in 2004, and its inclusion in the National Comp