Oncotype DX Test

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The Oncotype DX test is a genomic test that analyzes the activity of a group of genes that can affect how a cancer is likely to behave and respond to treatment. The Oncotype DX is used in two ways:

  • to help doctors figure out a woman’s risk of early-stage, estrogen-receptor-positive breast cancer coming back (recurrence), as well as how likely she is to benefit from chemotherapy after breast cancer surgery
  • to help doctors figure out a woman’s risk of DCIS (ductal carcinoma in situ) coming back (recurrence) and/or the risk of a new invasive cancer developing in the same breast, as well as how likely she is to benefit from radiation therapy after DCIS surgery

Of all the breast cancer genomic tests, the Oncotype DX test has the strongest research behind it.

The results of the Oncotype DX test, combined with other features of the cancer, can help you make a more informed decision about whether or not to have chemotherapy to treat early-stage, hormone-receptor-positive breast cancer or radiation therapy to treat DCIS.

What are genomic tests?

Genomic tests analyze a sample of a cancer tumor to see how active certain genes are. The activity level of these genes affects the behavior of the cancer, including how likely it is to grow and spread. Genomic tests are used to help make decisions about whether more treatments after surgery would be beneficial.

While their names sound similar, genomic testing and genetic testing are very different.

Genetic testing is done on a sample of your blood, saliva, or other tissue and can tell if you have an abnormal change (also called a mutation) in a gene that is linked to a higher risk of breast cancer. See the Genetic Testing pages for more information.

Who is eligible for the Oncotype DX test?

You may be a candidate for the Oncotype DX test if:

  • you’ve recently been diagnosed with stage I or II invasive breast cancer
  • the cancer is estrogen-receptor-positive
  • there is no cancer in your lymph nodes (lymph-node-negative breast cancer)
  • you and your doctor are making decisions about chemotherapy.

Most early-stage (stage I or II), estrogen-receptor-positive breast cancers that haven’t spread to the lymph nodes are considered to be at low risk for recurrence. After surgery, hormonal therapies such as an aromatase inhibitor or tamoxifen are prescribed to reduce the risk that the cancer will come back in the future. Whether or not chemotherapy is also necessary has been an area of uncertainty for patients and their doctors.

If you’ve been diagnosed with early-stage, estrogen-receptor-positive breast cancer, the Oncotype DX test can help you and your doctor make a more informed decision about whether or not you need chemotherapy. (Some research also suggests the test may help postmenopausal women with estrogen-receptor-positive breast cancer that has spread to the lymph nodes make chemotherapy decisions. Talk to your doctor if you are in this group.)

You also may be a candidate for the Oncotype DX test if:

  • you’ve recently been diagnosed with DCIS
  • you’re having lumpectomy to remove the DCIS

DCIS is the most common form of non-invasive breast cancer. DCIS usually is treated by surgically removing the cancer (lumpectomy in most cases). After surgery, hormonal therapy may be recommended if the DCIS is hormone-receptor-positive. Radiation therapy may be recommended for some women. Doctors aren’t always sure which women will benefit from radiation therapy.

If you’ve been diagnosed with DCIS, the Oncotype DX test can help you and your doctor make a more informed decision about whether or not you need radiation therapy.

How does Oncotype DX work?

The Oncotype DX genomic test analyzes the activity of 21 genes that can influence how likely a cancer is to grow and respond to treatment.

Looking at these 21 genes can provide specific information on:

  • the likelihood that the breast cancer will return
  • whether you’re likely to benefit from chemotherapy if you’re being treated for early-stage invasive breast cancer
  • whether you’re likely to benefit from radiation therapy if you’re being treated for DCIS

So, the Oncotype DX test is both a prognostic test, since it provides more information about how likely (or unlikely) the breast cancer is to come back, and a predictive test, since it predicts the likelihood of benefit from chemotherapy or radiation therapy treatment. Studies have shown that Oncotype DX is useful for both purposes.

Oncotype DX test results assign a Recurrence Score — a number between 0 and 100 — to the early-stage breast cancer or DCIS. You and your doctor can use the following ranges to interpret your results for early-stage invasive cancer:

  • Recurrence Score lower than 18: The cancer has a low risk of recurrence. The benefit of chemotherapy is likely to be small and will not outweigh the risks of side effects.
  • Recurrence Score of 18 up to and including 30: The cancer has an intermediate risk of recurrence. It’s unclear whether the benefits of chemotherapy outweigh the risks of side effects.
  • Recurrence Score greater than or equal to 31: The cancer has a high risk of recurrence, and the benefits of chemotherapy are likely to be greater than the risks of side effects.

The Oncotype DX DCIS score analyzes the activity of 12 genes. You and your doctor can use the following ranges to interpret your results for DCIS:

  • Recurrence Score lower than 39: The DCIS has a low risk of recurrence. The benefit of radiation therapy is likely to be small and will not outweigh the risks of side effects.
  • Recurrence Score between 39 and 54: The DCIS has an intermediate risk of recurrence. It’s unclear whether the benefits of radiation therapy outweigh the risks of side effects.
  • Recurrence Score greater than 54: The DCIS has a high risk of recurrence, and the benefits of radiation therapy are likely to be greater than the risks of side effects.

You and your doctor will consider the Recurrence Score in combination with other factors, such as the size and grade of the cancer, the number of hormone receptors the cancer cells have (many versus few), and your age. Together, you can make a decision about whether or not you should have chemotherapy or radiation therapy.

Insurance coverage and financial assistance

The Medicare program and several other major insurance companies have agreed to cover the Oncotype DX test. According to Genomic Health, about 90% of insured people in the U.S. are members of a plan that covers the test. If you discover that your plan does not cover the Oncotype DX test, talk to your doctor: he or she may be able to work with your insurance company to get coverage. If you have a low Recurrence Score and you and your doctor decide you do not need to have chemotherapy or radiation, your insurance company can save much more than the cost of the test.

Genomic Health also has started the Genomic Access Program to assist you with verifying insurance coverage and obtaining reimbursement. If you do not have or cannot secure insurance coverage, the Genomic Access Program still may be able to help. Various forms of financial assistance and payment plans are available for people facing financial hardships or those who are uninsured or underinsured. The Oncotype DX test costs about $4,000. For insurance- and payment-related questions, call 1-866-ONCOTYPE (1-866-662-6897).

Other genomic tests

There are other genomics tests used to analyze breast cancer tumors. To learn more, click on the links below.

  • The Breast Cancer Index test is used to predict the risk of node-negative, hormone-receptor-positive breast cancer coming back 5 to 10 years after diagnosis.
  • The EndoPredict test is used to predict the risk of distant recurrence of early-stage, hormone-receptor-positive, HER2-negative breast cancer that is either node-negative or has up to three positive lymph nodes.
  • The MammaPrint test is used to predict the risk of recurrence within 10 years after diagnosis of stage I or stage II breast cancer that is hormone-receptor-positive or hormone-receptor-negative.
  • The Mammostrat test is used to predict the risk of recurrence of early-stage, hormone-receptor-positive breast cancer.
  • The Prosigna Breast Cancer Prognostic Gene Signature Assay (formerly called the PAM50 test) is used to predict the risk of distant recurrence for postmenopausal women within 10 years of diagnosis of early-stage, hormone-receptor positive disease with up to three positive lymph nodes after 5 years of hormonal therapy.

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