FAQs

What is the Oncotype DX Colon Cancer assay?

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.

When should the Oncotype DX Colon Cancer Assay be used?

The Oncotype DX Colon Cancer Assay can be ordered as soon as resected colon tumor tissue is available for submission to the Genomic Health® clinical laboratory. The Oncotype DX Colon Cancer Assay is intended for use with patients newly diagnosed with Stage II or Stage III colon cancer following surgery.

How accurate are the results of the Oncotype DX Colon Cancer Assay?

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.

How does the Recurrence Score® result correlate with a patient's likelihood of recurrence?

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 colon cancer 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.

How was the gene panel for the Oncotype DX Colon Cancer Assay developed and validated?

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.

How can I incorporate the MMR results into clinical practice?

The QUASAR study results are consistent with several other published studies which demonstrate that MMR testing is clinically useful for identifying the ~15% of stage II patients with MMR-Deficient (MMR-D) tumor biology who have low recurrence risk and thus may be candidates to forego adjuvant chemotherapy. (Gray RG, et al. J Clin Oncol. 2011.)

How do I order the Oncotype DX Colon Cancer Assay?

The tumor analysis requires formalin-fixed, paraffin-embedded tumor tissue. Over 90% of Oncotype DX Colon Cancer Assay results are available within 7 to 10 days from the date laboratory processing begins. Please allow 1-2 additional days for MMR testing.

How much tumor tissue is required?

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.

How can I access reports?

The results of the Oncotype DX Colon Cancer Assay are available in the form of a patient report within 7 to 10 days from the date laboratory processing begins and are available for delivery via fax, overnight mail or secure online transfer. Please allow 1-2 additional days for MMR testing.

How are the results of the Oncotype DX Colon Cancer Assay reported when the Sequential Option is selected?

In the event of a MMR-P result, the patient’s tumor specimen will proceed to Oncotype DX testing, and in one convenient report, both results will be provided in 7 – 10 days from the date laboratory processing begins. In the event of a MMR-D result, an Oncotype DX assay will not be performed, and the ordering physician will be provided with a MMR report only.* The results of the Oncotype DX Colon Cancer Assay are presented as a Recurrence Score result (0-100). The report form is delivered via fax, overnight mail or secure online transfer. Click here for more information on reports.

*Please allow 1-2 additional days for MMR testing.

How are the results reported when the Oncotype DX Colon Cancer Assay only option is selected?

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. Click here for more information on reports.

Is the Oncotype DX Colon Cancer Assay covered by health insurance?

Currently, the Oncotype DX Colon Cancer Assay is a covered benefit for Stage II through Palmetto GBA, the national Medicare contractor for Genomic Health. In addition, Genomic Health is an in network laboratory provider for greater than 90% of commercially insured lives. We also offer 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. Lastly, Genomic Health also has a patient assistance program. For more information, visit our Insurance Information section. 

How should international specimens be handled?

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.

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