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Oncotype DX is a diagnostic test for people who are newly diagnosed with stage II colon cancer. 

The test starts by taking a tissue sample from a tumor during surgery. No additional invasive procedures are needed after surgery for the Oncotoype DX test to be performed.

The tissue sample is examined at a molecular level. The result of the test is what is known as a Recurrence Score which provides statistical information about the possibility of a recurrence within 3 years from initial diagnosis.  In turn, this helps determine the appropriate treatment for the particular person.

KEEP IN MIND that statistics about colon cancer are about large numbers of people, and do not necessarily predict what will happen to any particular individual. Although the Oncotype DX test can predict whose cancer will recur, it cannot predict who will respond to treatment. Similarly, cancer can recur with a low score, and it may not recur with a high score.

Oncotype DX is covered by Medicare and is usually covered by most other health insurance coverages as well. If Oncotype DX is not covered in your situation, or if you are uninsured, and you need financial assistance, speak with your doctor about contacting Genomic Health for financial assistance. For information, go to www.ccalliance.org/pdf/OncotypeColonCancerAssay.pdf offsite link or call Genomic Health at 866-ONCOTYPE (866.662.8973).

How the Oncotype DX Test Is Performed

Once the sample tissue is removed, it is preserved in thin sections. Several of the sections are placed in a container and sent to the Genomic Health Laboratory in California where the test was developed and is performed.

When the sample arrives at the lab, RNA (a nucleic acid present in all living cells) is extracted from the sample and analyzed to determine the level of activity or expression of each of twelve genes.

  • Seven of the genes measure recurrence

  • Five of the genes are reference genes.

The results of the analysis are put into a complicated mathematical formula to create a Recurrence Score. The Recurrence Score is a number from 1 to 100 that reflects the likelihood that colon cancer will recur or metastasize within 3 years of the initial diagnosis. A lower score indicates that the cancer is not likely to return. A higher score indicates a greater likelihood that the cancer may return.

A detailed report, including the Recurrence Score is sent to your doctor or other healthcare, provider via overnight mail or secure e-mail. The results are then integrated with other test results and clinical findings to help the two of you decide about individualized treatment.

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