ArticleBMC cancer2010
Translating tumor biology into personalized treatment planning: analytical performance characteristics of the Oncotype DX Colon Cancer Assay.
Article in BMC cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers.
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Who cites it
59 citing papers in PubMed, 94 citations in OpenAlex.
- Trial
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- The Role of Gene Expression Profiling in the Management of Cutaneous Squamous Cell Cancer: A Review.Cancers · 2024Review
- Explainable Machine Learning Models Using Robust Cancer Biomarkers Identification from Paired Differential Gene Expression.International journal of molecular sciences · 2024Article
- The Prognostic Value of the 31-Gene Expression Profile Test in Cutaneous Melanoma: A Systematic Review and Meta-Analysis.Cancers · 2024Review
- Article
- Principles of Molecular Utility for CMS Classification in Colorectal Cancer Management.Cancers · 2023Review
- A prognostic six-gene expression risk-score derived from proteomic profiling of the metastatic colorectal cancer secretome.The journal of pathology. Clinical research · 2022Article
- Article
- Gene-expression profiles of pretreatment biopsies predict complete response of rectal cancer patients to preoperative chemoradiotherapy.British journal of cancer · 2022Article
- Patient-specific meta-analysis of 12-gene colon cancer recurrence score validation studies for recurrence risk assessment after surgery with or without 5FU and oxaliplatin.Journal of gastrointestinal oncology · 2022Article
- Identification of a Novel Five-Gene Signature as a Prognostic and Diagnostic Biomarker in Colorectal Cancers.International journal of molecular sciences · 2022Article
- Sustainable Clinical Development of Adjuvant Chemotherapy for Colon Cancer.Annals of gastroenterological surgery · 2022Review
- A new paradigm for leprosy diagnosis based on host gene expression.PLoS pathogens · 2021Article
- Transcriptional epigenetic regulation of Fkbp1/Pax9 genes is associated with impaired sensitivity to platinum treatment in ovarian cancer.Clinical epigenetics · 2021Article
- Review
- A tumor microenvironment-specific gene expression signature predicts chemotherapy resistance in colorectal cancer patients.NPJ precision oncology · 2021Article
- A universal molecular prognostic score for gastrointestinal tumors.NPJ genomic medicine · 2021Article
Corrections and comments
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Authors and funding
4 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.