Oncotype DX Test
What is the Oncotype DX Breast Recurrence Score® test?
The Oncotype DX Breast Recurrence Score test is a genomic test, also known as a gene expression test, used for certain breast cancers. The test looks at the activity of specific genes in breast cancer tumor tissue to help give you and your care team a better understanding of your risk of breast cancer recurrence and whether chemotherapy may be a beneficial treatment for you.
Genes act like instructions that tell cells how to work and behave. In breast cancer cells, some genes may be more active or less active than others. By looking at these patterns of gene activity in a sample of the tumor, the test can provide more information about the cancer and its likelihood of recurrence.
The testing is performed in a specialized laboratory using a sample of tumor tissue that was already removed during a biopsy or breast surgery.
Jump to:
Is the Oncotype DX test a genetic test?
How the Oncotype DX test works
Who is the Oncotype DX test for?
Understanding your Recurrence Score
Oncotype DX Breast DCIS Score test
Getting the test: Timing, results, and cost
Oncotype DX frequently asked questions
Is the Oncotype DX® test a genetic test?
The Oncotype DX test is a genomic test, which is different from a genetic test.
A genomic test looks at how active certain genes are within the breast cancer tumor. A genetic test looks for inherited gene changes, such as BRCA1 and BRCA2 mutations, that a person is born with and may pass down in their family.
This difference is important because genomic and genetic tests answer different questions. Genomic testing can help guide treatment for breast cancer that has already been diagnosed. Genetic testing looks for inherited gene changes that may increase your risk of certain cancers and may also affect your family members’ cancer risk.
How the Oncotype DX test works
In most cases, you will not need another biopsy or procedure for the test. A small sample of breast cancer tissue that was already removed during your initial biopsy or surgery can be used for testing.
Your tumor tissue is kept by the pathology lab where it was examined. When your oncologist orders the test, the pathology team prepares a small sample of this tissue to be sent for testing. The sample is then shipped to the specialized laboratory where the testing is performed. You do not need to collect or send the tissue yourself.
Once the sample arrives at the lab, the test looks at the activity of 21 genes within the tumor. Of these, 16 are related to cancer behavior and five are reference genes used for comparison. The information from all 21 genes is then used to calculate one number, called the Recurrence Score (RS).
The Recurrence Score ranges from 0-100 and gives your care team more information to help guide treatment decisions. Most results are available within about two weeks after the lab receives the tumor sample. The results are sent to your doctor, who will review your Recurrence Score with you and explain what it may mean for your treatment.
Who is the Oncotype DX test for?
The Oncotype DX test is designed for people with certain early-stage, hormone receptor-positive (HR+), HER2-negative invasive breast cancers. Your doctor will look at the features of your cancer to decide whether the test may be helpful when planning your treatment.
The test may be considered when the breast cancer is:
- Early-stage invasive breast cancer
- Hormone receptor-positive (HR+), also called estrogen receptor-positive (ER+) and/or progesterone receptor-positive (PR+) breast cancer
- HER2-negative breast cancer
- No cancer in the lymph nodes (node-negative) or, in certain cases, cancer in 1 to 3 nearby lymph nodes. For people with 1-3 positive lymph nodes, whether the test is useful for guiding chemotherapy decisions depends in part on your menopausal status. Your cancer care team will consider these factors when deciding whether the Oncotype DX test is appropriate for you.
- Able to receive chemotherapy if the results suggest it may be beneficial
Research has shown that some women who have gone through menopause and have a Recurrence Score of 25 or lower may not benefit from adding chemotherapy to hormone therapy. However, women who have not yet gone through menopause may still benefit from chemotherapy, even with a low Recurrence Score. Your cancer care team will consider whether you have gone through menopause, along with your test results and other features of your cancer, when recommending treatment.
The test is generally not used for HER2-positive or triple-negative breast cancer (TNBC), because treatment decisions for these types of breast cancer are made using other information.
Oncotype DX may also be used in men with certain types of early-stage breast cancer, although there is less research specifically studying the test in men. Current guidelines recommend using this type of testing to help guide treatment decisions in men in the same way it is used for women.
Understanding your Recurrence Score
The Oncotype DX Breast Recurrence Score is a number from 0-100. In general, a lower score is linked to a lower risk of distant recurrence (the cancer returning in another part of the body) and less expected benefit from chemotherapy. A higher score is linked to a higher risk of distant recurrence and a greater chance that chemotherapy may help.
It’s important to note that your Recurrence Score is not a percentage. For example, a Recurrence Score of 18 does not mean you have an 18% chance of your cancer returning. Your Oncotype DX report provides your Recurrence Score and your estimated risk of distant recurrence as separate numbers.
What your score range means
You may see different Recurrence Score ranges depending on where you look. This is because the scores have been grouped differently over time as researchers have learned more about how the Oncotype DX test can help guide treatment.
The Recurrence Score ranges from 0-100. When discussing potential chemotherapy benefit, scores are currently grouped into two ranges: lower score range (0–25) and higher score range (26–100). Older clinical studies categorized scores into three categories: low (0-17), intermediate (18-30), and high (31-100).
Oncotype DX Breast Recurrence Score ranges are listed below. If you have been tested, your report will provide your specific Recurrence Score.
Recurrence Score | Current framing* | Older three-group framing |
0-17 | Lower score range | Low |
18-25 | Lower score range | Intermediate |
26-30 | Higher score range | Intermediate |
31-100 | Lower score range | High |
*The 0-25 (lower score) and 26-100 (higher score) ranges are currently used when discussing chemotherapy benefits based on research such as TAILORx. However, the significance of a Recurrence Score depends on factors such as menopausal status, lymph-node status, and other clinical characteristics. These ranges alone cannot determine a person’s individual risk or expected chemotherapy benefit.
In general, the higher the score, the higher the risk of distant recurrence and the greater the expected benefit from chemotherapy.
However, your score does not tell the whole story and is only one part of the treatment decision. In addition to your Recurrence Score, your cancer care team will also consider factors such as your age, tumor size, tumor grade, and whether cancer is found in the lymph nodes.
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Get the Free eBookWhat your score means for chemotherapy and hormone therapy
The Recurrence Score can help your cancer care team decide whether adding chemotherapy to hormone therapy as part of your treatment regimen is likely to provide additional benefit.
For people with hormone-positive (HR+), HER2-negative breast cancer that has not spread to the lymph nodes, the TAILORx trial found that most people with a Recurrence Score of 11-25 did not benefit from adding chemotherapy to hormone therapy. However, some people aged 50 or younger with scores of 16-25 appeared to have a small benefit from chemotherapy. Researchers do not yet know how much of this benefit comes directly from chemotherapy and how much may come from chemotherapy lowering ovarian function.
Lymph node involvement also matters. The RxPONDER trial studied people with hormone-positive (HR+), HER2-negative breast cancer with 1-3 positive lymph nodes and a Recurrence Score of 0-25. Premenopausal women in the study benefited from adding chemotherapy to hormone therapy, while postmenopausal women did not show the same benefit from chemotherapy.
These differences are why your Recurrence Score should not be looked at by itself and why other factors will be taken into consideration by your care team.
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Get the Free eBookThe Oncotype DX Breast DCIS Score® test
There is a separate version of the Oncotype DX test for those with Stage 0 ductal carcinoma in situ (DCIS), an early-stage, non-invasive breast cancer. The Oncotype DX Breast DCIS Score test uses its own score ranges, which are different from those used for invasive breast cancer.
Because treatment options for DCIS can vary, the DCIS Score provides information about the risk of the DCIS returning in the same breast. This test can help you and your provider make informed decisions about treatment.
The DCIS Score ranges from 0-100 and has traditionally been grouped as low (<39), intermediate (39-54), or high (55+) based on the risk of the cancer returning in the same breast. Unlike the Recurrence Score for invasive breast cancer, the DCIS Score can help patients and their care teams make more personalized decisions about radiation therapy after lumpectomy (breast-conserving surgery).
Getting the test: Timing, results, and cost
The Oncotype DX test is usually ordered after a biopsy or breast cancer surgery and before decisions are made about additional treatment, such as chemotherapy. The test uses tumor tissue that has already been removed, so you typically do not need another procedure.
Once the test is ordered, your tumor sample is sent to the Exact Sciences laboratory for testing. Most results are available within about two weeks after the lab receives your sample and are sent to the healthcare provider who ordered the test. Your provider will then review the results with you.
The Oncotype DX test is usually covered by Medicare for eligible patients, though coverage may vary. Many private insurance plans also cover testing. However, coverage and out-of-pocket costs can vary depending on your plan. Exact Sciences offers financial assistance and support programs for eligible patients who need help with the cost of testing. Per Exact Sciences, 86% of patients pay $0, and 91% of patients pay less than $100.
Coverage varies by insurance plan, so check with your insurance provider or patient navigator for more information about your coverage.
Patient Navigation Program
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Find a Patient NavigatorOncotype DX frequently asked questions
Can my Recurrence Score change?
Since the Recurrence Score is based on the gene activity within specific tumor tissue, it is not a number routinely checked again, like a blood test. Therefore, the Recurrence Score will not change.
Does a low Recurrence Score mean my breast cancer will not come back?
A Recurrence Score is an estimated risk of recurrence, not a guarantee that breast cancer will or will not recur. A lower Recurrence Score is linked to a lower risk of distant recurrence, but it cannot guarantee that breast cancer will never return.
Does a high Recurrence Score mean my breast cancer will come back?
While a higher score is associated with a higher risk of distant recurrence, it does not mean that recurrence will definitely happen. A higher score also suggests that chemotherapy is more likely to provide benefit in reducing the risk of recurrence.
Is the Oncotype DX test a genetic test?
No. The Oncotype DX test is a genomic test, which looks at the activity of certain genes within breast cancer itself. This is different from genetic testing for inherited gene changes, which is usually done using a blood or saliva sample.
What is a good Recurrence Score?
There isn’t one score considered “good” for everyone. In general, a lower score is linked to a lower risk of distant recurrence and less expected benefit from chemotherapy, while a higher score is linked to a higher risk of distant recurrence and a greater expected benefit from chemotherapy. Your age, menopausal status, lymph node involvement, and other tumor features also help determine what your score means for you.
Can the Oncotype DX test be used for triple-negative breast cancer (TNBC)?
No. This test is not used to guide treatment for triple-negative breast cancer. Treatment decisions for triple-negative breast cancer are based on other features of the cancer and the person’s individual situation.
How long does it take to get Oncotype DX test results?
Most Recurrence Score results are available within about two weeks after the laboratory receives the tumor sample. Results are sent to the healthcare provider who ordered the test.
How much does the Oncotype DX test cost, and is it covered by insurance?
Many private insurance plans, Medicare, and Medicaid may cover the testing for eligible patients. Coverage and out-of-pocket costs vary by insurance plan, and Exact Sciences offers financial assistance for some eligible patients. Your insurance provider and/or patient navigator can help you understand your individual coverage and possible costs.
Does a Recurrence Score of 20 mean I have a 20% chance of recurrence?
No. Your Recurrence Score is a number from 0-100, but it is not a percentage. For example, a score of 20 does not mean you have a 20% chance of your cancer returning. Your test report will provide your estimated risk of distant recurrence separately.
Why might two people with the same Recurrence Score receive different treatment recommendations?
The Recurrence Score is only one part of the treatment decision. Two people with the same score may have different ages, menopausal status, lymph node involvement, tumor features, or other health considerations that affect whether chemotherapy is likely to provide enough benefit to recommend it.
Can the Oncotype DX test tell whether my cancer has spread?
No. The test does not look for cancer elsewhere in the body. Imaging and other tests may be used when needed to determine whether breast cancer has spread.
How is the Oncotype DX Breast Recurrence Score test different from MammaPrint?
The Oncotype DX Breast Recurrence Score test and MammaPrint® are both genomic tests that analyze gene activity within breast cancer and can help guide treatment decisions. Oncotype DX analyzes 21 genes and provides a Recurrence Score from 0-100 for certain HR-positive, HER2-negative breast cancers. MammaPrint analyzes 70 genes and classifies certain early-stage breast cancers by their risk of distant recurrence. The tests also have different eligibility criteria. Your cancer care team can determine whether either test is appropriate for you.
Oncotype DX, Oncotype DX Breast Recurrence Score, and Oncotype DX Breast DCIS Score are registered trademarks of Abbott.
MammaPrint is a registered trademark of Agendia, Inc.