Frequently Asked Questions
Below are answers to frequently asked questions about the Oncotype DX® test.
The Oncotype DX Colon Cancer Assay predicts the risk of colon cancer recurrence in men and women with newly diagnosed stage II colon cancer following surgery. The test analyzes the expression of a panel of 12 genes.
Research and validation studies have already been performed on the 12-gene Oncotype DX Colon Cancer Assay for stage II colon cancer. The Oncotype DX Colon Cancer Assay is currently commercially available for this indication. The Oncotype DX Colon Cancer Assay was developed and its performance characteristics were determined by Genomic Health, Inc. The laboratory is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. The Oncotype DX Colon Cancer Assay is used for clinical purposes, and it should not be regarded as investigational or for research purposes. Oncotype DX Colon Cancer Assay results are adjunctive to the ordering physician’s workup.
The Oncotype DX Colon Cancer Assay is clinically validated for newly diagnosed colon cancer patients with stage II disease who have undergone surgical resection. If you have questions about Oncotype DX testing for a specific patient, please contact Customer Service at Domestic Phone: 866-ONCOTYPE (866-662-6897), or International Phone: +1-650-569-2080.
The Oncotype DX Colon Cancer Assay can be ordered as soon as resected colon tumor tissue is available for submission to Genomic Health. The Oncotype DX Colon Cancer Assay is intended for use in women and men newly diagnosed with stage II colon cancer following surgery
The Oncotype DX Colon Cancer Assay was developed in extensive laboratory and clinical studies and was validated in an independent clinical study with prospectively-defined endpoints. The results of the validation study of the Oncotype DX Colon Cancer Assay in stage II colon cancer patients were presented at ASCO 2009.
The Oncotype DX Colon Cancer Assay Recurrence Score result is provided on a scale of 0 to 100. Each Recurrence Score result is calculated based on the results of the patient's tumor gene expression profile. For stage II colon cancer patients, the Recurrence Score result correlates to a specific likelihood of recurrence as observed in the clinical validation study.
The identification of the gene panel for the Oncotype DX Colon Cancer Assay started with an extensive analysis of the human genome. Following the identification of a large set of genes associated with colon cancer, four developmental studies explored the expression of 761 genes in patient tumor samples that were obtained at the time of initial diagnosis of colon cancer. The results of these studies were analyzed and used to develop a 12-gene assay that incorporated the genes which consistently correlated with recurrence-free survival. This assay was then validated, using prospectively-defined endpoints, in an independent clinical study of 1,436 patients from the landmark QUASAR Study.
Materials necessary for sample collection and submission are provided in the Oncotype® DX Colon Cancer Specimen Kit, which can be ordered through Genomic Health. Tumor samples are submitted to the Genomic Health Laboratory for analysis. Click here for more information about ordering the assay.
The Oncotype DX Colon Cancer Assay is performed using formalin-fixed, paraffin-embedded colon tumor tissue obtained by surgical resection or biopsy.
The Oncotype DX Colon Cancer Assay requires either one tumor block OR 15 unstained slides (5 micron tissue sections). Unused portions of the tumor block will be returned.
The results of the Oncotype DX Colon Cancer Assay are presented as a Recurrence Score result (0-100). In addition to the individual test results, an overview of the clinical validation study is provided which correlates Recurrence Score result with likelihood of recurrence at 3 years in patients with stage II colon cancer. The report form is delivered via fax, overnight mail or secure online transfer. Click here for more information on reports.
The results of the Oncotype DX Colon Cancer Assay will typically be available within 7 to 10 days from the date the tumor sample is received by Genomic Health. The results of the test will be returned via fax, overnight mail or secure online transfer.
It is unknown at this time whether carriers will initiate coverage of the Oncotype DX Colon Cancer Assay for patients with stage II colon cancer following surgery. Genomic Health has a program called the Genomic Access Program (GAP) that can help you verify whether or not your insurance covers the test and, if so, can help you obtain reimbursement. Genomic Health also has a patient assistance program. For more information, visit our Insurance Information section. Click here for more information about insurance coverage and reimbursement.
Genomic Health is able to accept specimens from outside the U.S. for the Oncotype DX Colon Cancer Assay. In addition to all other requirements for these specimens, payment is required prior to processing. Payment can be accepted in the form of valid credit card information, submitted on the Requisition Form or an international money order in U.S. dollars. A Customs Declaration is also required for the specimen to be accepted into the United States. A sample Customs Declaration can be found here. Oncotype DX Specimen Kits comply with international packaging regulations for diagnostic specimens (IATA 650 Packaging Instruction). Please contact our Customer Service Department, 866-ONCOTYPE (866-662-6897), in advance to discuss any special requirements.