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Oncotype DX tests help doctors predict the future activity of cancer by analyzing genes in samples of breast, prostate, or colon cancer cells. The test results can help determine the risk of metastasis, which is when cancer appears or returns to a distant part of the body. They can also help predict the potential benefits of chemotherapy or radiation therapy.

A large amount of research supports the use of Oncotype DX testing for predicting the future activity of invasive breast cancer.

In their latest guidelines, the National Comprehensive Cancer Network (NCCN) lists the Oncotype DX Breast Recurrence Score as their preferred gene expression test for predicting future chemotherapy benefits in those with breast cancer.

There are fewer studies validating the use of Oncotype DX testing for colon and prostate cancer, but clinical trials have found promising results.

In this article, we break down everything you need to know about Oncotype DX tests, including how to interpret your results, the benefits, and the procedure.

Oncotype DX tests are genomic tests produced by Genomic Health, Inc., which is now part of the company Exact Sciences. These tests can help medical professionals predict the future activity of breast cancer, prostate cancer, or colon cancer.

Genomic tests work by analyzing the activity level of certain genes found in cancer cells. Researchers have identified certain gene alterations linked to specific patterns of cancer development.

Medical professionals can use the results of your Oncotype DX test along with the results of other tests to predict:

  • whether you will benefit from chemotherapy or radiation therapy
  • the chances of your early stage cancer returning in a distant part of your body

Oncotype DX test procedure

Oncotype DX tests analyze a small sample of cancer cells. The cells are obtained from cancer samples previously collected through a biopsy or surgery.

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Oncotype DX testing is available for breast, colon, and prostate cancer. According to the Oncotype IQ website, eligibility for these tests are as follows:

Breast cancer Oncotype DX tests

There are two types of Oncotype DX testing for breast cancer.

  • Oncotype DX Breast Recurrence Score test: helps predict the benefit of chemotherapy and risk of distant cancer reoccurrence in people with early stage estrogen receptor(ER)-positive and human epidermal growth factor receptor 2(HER2)-negative breast cancer.
  • Oncotype DX Breast DCIS Score test: provides predictive information about the 10-year reoccurrence rate and benefit of radiation therapy in people with early stage ductal carcinoma in situ (DCIS) cancer
Oncotype DX Breast Recurrence Score
Test eligibility
Oncotype DX Breast DCIS Score
Test eligibility
You’ve recently received a diagnosis of invasive breast cancer.You’ve recently received a diagnosis of DCIS.
You’re medically eligible for chemotherapy.You’ve been treated with a lumpectomy or have had a core biopsy.
Your cancer is:
– in stage 1, 2, or 3A
– ER-positive
– HER2-negative

Prostate cancer

Prostate cancer Oncotype DX eligibility
You haven’t had a prostate biopsy within 3 years.
You haven’t had surgery or started radiation.
Your cancer falls into the NCCN’s very low, low, or intermediate risk categories.

Colon cancer

Colon cancer Oncotype DX eligibility
You have a new diagnosis, and your cancer is:
– stage 2 or 3 A/B
– T3
– MMR-P
You haven’t undergone surgical removal of your tumor.
You haven’t started chemotherapy or other treatments.

Oncotype DX testing, together with other prognostic tests, can help your doctor determine how your cancer will act and whether the benefits of chemotherapy or radiation therapy outweigh the side effects and costs. Your test score can be interpreted with other markers such as your age and tumor grade and size.

Studies have reported Oncotype DX testing altering the decision to administer chemotherapy in as many as 30 percent of doctors treating people with ER-positive and HER2-negative breast cancer.

Oncotype DX testing may be most beneficial for people with medium-risk cancer, where it’s unclear if chemotherapy or radiation therapy would increase the chances of survival.

In the large TAILORx clinical trial, researchers compared the benefit of chemotherapy guided by gene testing in a group of 9,719 women with ER-positive and HER2-negative breast cancer. In women over age 50 with medium Oncotype DX scores, the researchers found no significant difference in overall survival between women who:

  • received hormone therapy alone
  • received hormone therapy and chemotherapy together

The researchers found some benefit of adding chemotherapy to treatment in women under age 50 with a medium score.

The results your test provides depends on the type of test and the type of cancer you have.

Oncotype DX Breast Recurrence Score results

The Oncotype DX Breast Recurrence Score eligibility looks at the activity of 21 genes. It provides you with a recurrence score from 0 to 100.

For women over age 50:

Reoccurrence scoreInterpretation
0–25Your cancer has a low risk of reoccurring. Chemotherapy is likely not recommended.
26–100Your cancer has a high risk of returning. Chemotherapy is likely recommended.

For women under age 50:

Reoccurrence scoreInterpretation
0–15Your cancer has a low risk of returning. Chemotherapy is likely not recommended.
16–20Your cancer has a low to medium risk of returning. Chemotherapy is likely not recommended.
21–25Your cancer has a medium risk of returning. Chemotherapy is likely recommended.
26–100Your cancer has a high risk of returning. Chemotherapy is likely recommended.

Oncotype DX Breast DCIS Score results

The DCIS test analyzes the activity of 12 genes. This test also gives you a score from 0 to 100. Here’s how the results are interpreted:

Reoccurrence scoreInterpretation
0–39Your cancer has a low risk of returning. Radiation therapy is likely not recommended.
39–54There’s a medium risk of your cancer returning. Radiation therapy may or may not be recommended.
55–100There’s a high risk of your cancer returning. Radiation therapy is likely recommended.

Prostate cancer Oncotype DX results

The prostate cancer Oncotype DX test analyzes 12 genes to produce a score from 0 to 100 correlating with the aggressiveness of your cancer.

Your patient report will provide you with a rating of your cancer from very low to high risk. The report also gives you your odds of death from cancer within 10 years and the chances of your cancer progressing to a Gleason score over 4 + 3 or pT3.

Colon cancer Oncotype DX results

The colon cancer Oncotype DX test analyzes 12 genes and provides a score from 0 to 100 indicating your risk of reoccurrence. The test also provides you with the odds of your cancer returning with 3 years or within 5 years.

Many studies have validated the accuracy of Oncotype DX testing for invasive breast cancer. The NCCN guidelines list the level of evidence of Oncotype DX testing for predicting chemotherapy benefit in postmenopausal women as level 1, which is the highest level.

Level 1 evidence means the researchers are basing their opinion on the results of reviews of randomized controlled trials, the gold standard for evaluating a test’s validity.

The NCCN lists the level of evidence in premenopausal women as 2A, meaning the recommendation is based on review of cohort studies, or studies following a group of participants over a period of time.

Fewer studies have validated the accuracy of Oncotype DX testing for prostate and colon cancer.

A 2021 study performed by the American Society of Clinical Oncology found that Oncotype DX testing may help predict the 20-year risk of prostate cancer-specific mortality and the chances of distant spreading.

The first study providing validation of Oncotype DX testing stage 2 and 3 colon cancer was called the SUNRISE study. The study found evidence to support the predicting capabilities of Oncotype DX testing and the ability of the test to help medical professionals predict future cancer activity.

Oncotype DX test results less accurate for Black women

According to the National Cancer Institute, Oncotype DX breast cancer testing may be less accurate for Black women than for non-Hispanic white women.

The researchers of a 2021 study found that Oncotype DX tests performed for Black women in the United States had a lower predictive accuracy, suggesting that the test may need recalibration when used as a predictor for some racial groups.

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The Oncotype DX test costs about $4,000. The Genomic Access Program (GAP) can help you navigate insurance coverage and payment options for the test, as well as answer any questions you may have. This program also covers financial assistance for those without insurance.

You can contact the program by phone at 888-ONCOTYPE (888-662-6897) or via the website’s Contact Us page.

Oncotype DX tests help predict future activity of your cancer by analyzing certain genes found in cancer cells. At this time, tests are available for some types of breast cancer, prostate cancer, and colon cancer.

Oncotype DX testing can help you and your doctor understand the risk of your cancer reoccurring or spreading to a distant part of your body. It can also help predict whether the benefits of adding chemotherapy or radiation to your treatment outweigh the side effects and cost.