Oncotype DX Frequently Asked Questions (FAQs)

The Oncotype DX test is a unique genomic test created to help women recently diagnosed with either early-stage invasive breast cancer or DCIS (non-invasive) breast cancer. It is important that your doctor request the Oncotype DX test before you start any treatment, since the test results are intended for use in guiding the selection of your treatment.

The Oncotype DX test provides a Recurrence Score result (patients with early-stage invasive breast cancer) or a DCIS Score result (patients with non-invasive breast cancer) that assigns a numerical value to the likelihood that a woman's early-stage invasive breast cancer will return recurrence). For early-stage invasive breast cancer only, the Oncotype DX test will also show how likely she is to benefit from chemotherapy in addition to hormonal therapy. In the case of women with DCIS breast cancer, it helps to predict whether the cancer will come back in the same breast – a key factor in deciding the treatment following surgery. The information provided by the Oncotype DX test result has been shown to improve the confidence of both doctors and women when selecting a treatment plan.

If you are a woman who has recently been diagnosed with Stage 0 (DCIS or non-invasive disease), Stage I or II (invasive disease), node-negative or node-positive, estrogen receptor-positive breast cancer and have not yet begun a chemotherapy or radiation therapy regimen, the Oncotype DX test may be appropriate for you. However, the decision to use the Oncotype DX test is one that you and your doctor should discuss and make together.

Genetic tests look at an individual's inherited traits or genes and can be used to help predict your risk for getting a certain disease like cancer. Genomic tests look at groups of genes and how active they are. They can be used after you have contracted a disease like cancer to help you understand its specific characteristics and how to treat it. For example, the Oncotype DX test looks at a panel of your genes and their activity in breast tumor tissue to help tailor treatment to your individual cancer.

The Oncotype DX test is the only genomic breast cancer test incorporated into all major international breast cancer treatment guidelines, which are developed by medical experts to help doctors provide the best possible care. Recommending organizations include the American Society of Clinical Oncology, (ASCO), the National Comprehensive Cancer Network (NCCN), the St. Gallen Consensus panel, the National Institute for Health Care Excellence (NICE), and the European Society for Medical Oncology (ESMO).

The Oncotype DX test is not appropriate for women with metastatic (stage IV) breast cancer. The Oncotype DX test provides clinical experience information for use in women with non-invasive and certain types of early-stage invasive breast cancer.

It is essential that all newly diagnosed breast cancer patients, and the people who love them, understand the important distinctions between these tests so that they can get the information they need to make a well-informed, individualized treatment decision.

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¹ MammaPrint is a registered trademark of Agendia BV. Prosigna is a trademark of NanoString Technologies, Inc. Please refer to these manufacturers directly for more information.

The Oncotype DX test report includes your Recurrence Score result or DCIS Score result, which is a number between 0 and 100. In the case of DCIS (non-invasive) breast cancer, the score can help to determine the risk of your DCIS returning, or recurring, in the same breast – a key factor when deciding your treatment following surgery lumpectomy or mastectomy). In the case of early-stage invasive breast cancer, the Recurrence Score is used to indicate the likelihood that your cancer will return or recur, as well as the likelihood that you will benefit from chemotherapy in addition to hormonal therapy following your surgery. The Oncotype DX test adds information beyond traditional factors such as tumor size, tumor grade, and age by looking at the biological makeup of your tumor. It is important to note that the Oncotype DX test results provide information about the likelihood of recurrence — they cannot determine with certainty whether breast cancer will or will not return. Learn more.

You and your doctor will work together to make this very personal decision, but the Oncotype DX test is an important tool to consider using together with other information when deciding whether or not to undergo chemotherapy for invasive breast cancer or radiation therapy for DCIS (non-invasive) breast cancer. You and your doctor should consider the Oncotype DX test results along with other diagnostic information and findings, as well as your own personal preferences, in determining which treatment plan is right for you.

The results of the Oncotype DX test can help your doctor understand how likely you are to benefit from chemotherapy commonly used to treat early-stage invasive breast cancer, but the test will not specifically identify which chemotherapy treatments to use. In the case of DCIS (non-invasive) cancer, the results of the Oncotype DX test can help tell you whether or not you should proceed with further treatment after surgery. The results of the Oncotype DX breast cancer test should be used with other diagnostic information and findings, as well as your own personal preferences, to help you and your doctor with treatment planning.

No. The results of the Oncotype DX test are intended to be used together with the results of other laboratory tests that are performed by your doctor to evaluate breast cancer.

The Oncotype DX test can only be ordered by an authorized healthcare professional. It is a non-invasive test that is performed on a small amount of tissue that was removed during your original surgery core biopsy, lumpectomy or mastectomy). You do not have to undergo any additional procedures to have the Oncotype DX test.

Most test results are available within 7 to 10 days from the date your tumor sample is received by the Genomic Health laboratory. The Oncotype DX test report is sent to both your doctor and the pathologist who submitted the tissue sample.

The Oncotype DX process is performed using a very small sample of the tumor tissue that was removed during your core biopsy, lumpectomy, or mastectomy. This means that no additional procedure is needed for this test. In the U.S., tumor samples are commonly treated with a preservative called formalin and then embedded in paraffin wax to form a small block. The Oncotype DX process is designed for use with a small sample from this type of tissue block.

Your doctor works with a pathologist who prepares a tissue specimen from your biopsy. The pathologist uses a special kit to submit the tumor sample to the Exact Sciences Laboratory for analysis.

Most U.S. insurance carriers, including Medicare, Aetna, United Healthcare, and CIGNA, cover the Oncotype DX test for early-stage, node-negative, estrogen receptor-positive, invasive breast cancer patients, but some carriers have yet to establish coverage policies for DCIS (non-invasive) and node-positive breast cancers.

The Genomic Access Program (GAP) can help you verify whether your insurance covers the test and, if so, help you obtain reimbursement. GAP is designed for women covered by a U.S. insurance company. Please note that you may be financially responsible for some or all of the cost associated with the test. If your insurance carrier does not cover some or all of the cost of the test, you can request GAP's assistance in setting up a payment plan. To learn more about GAP, please call Customer Service at 855.5000.ASK (855-500-0275).

Exact Sciences believes that every eligible patient should have access to the Oncotype DX test. The company offers the following programs:

• Uninsured patient assistance
• Financial assistance for qualified underinsured patients
• Payment plans to meet your financial needs

For details, please call Customer Service at 855.5000.ASK (855-500-0275).

Exact Sciences understands that being financially responsible for some or all of the costs associated with the Oncotype DX test may be a financial burden. The company offers financial assistance plans to help. The plans take into account your income and financial obligations such as house or rental payments, car payments, children's education, medical expenses, and other qualifying expenses. For more information, contact Customer Service at 855.5000.ASK (855-500-0275).