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Helping Guide Your Early-Stage Breast Cancer Treatment Decisions.

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Sandy - Diagnosed with breast cancer in 2006.

Note: The majority of these FAQs are intended for patients with invasive breast cancer. To learn more about the Oncotype DX DCIS Score for pre-invasive breast cancer, please click here.

About Oncotype DX:
Interpreting the Results of Oncotype DX:
Reimbursement for Oncotype DX:
Ordering Logistics:
Q: What is the OncotypeDX®test?
A: The Oncotype DX test is a cancer test that looks at the activity of certain genes within a tumor sample. For additional information about the Oncotype DX test, click here.
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Q: When should the Oncotype DX test be used?
A: Validation studies have been performed on the Oncotype DX Breast Cancer Assay for patients with pre-invasive or DCIS, node-negative and node-positive, estrogen-receptor-positive (ER+) breast cancer; for single gene reporting quantitative of ER (estrogen receptor), PR (progesterone receptor negative) and HER2 (human epidermal growth factor receptor 2) genes, and for patients treated with Tamoxifen or an Aromatase Inhibitor. The Oncotype DX breast cancer tests are currently commercially available. For detailed information please call: (866) ONCOTYPE or visit www.oncotypedx.com.
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Q: What are the benefits of the Oncotype DX test?
A: The Oncotype DX test provides a Recurrence Score result that assigns a numerical value to the likelihood that a woman's invasive breast cancer will return (distant recurrence) and how likely she is to benefit from chemotherapy in addition to hormonal therapy. The information provided by the test result may improve the confidence that both doctors and women with breast cancer may have that their treatment planning will be based on an understanding of each woman's individual disease characteristics.
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Q: Is the Oncotype DX test right for me?
A: If you are a woman who has recently been diagnosed with Stage I or II (invasive disease), node-negative, estrogen receptor-positive breast cancer and have not yet begun a chemotherapy treatment regimen, the Oncotype DX test may be appropriate for you. An additional study conducted in 2007 has shown that the test may also be informative for recently diagnosed, post-menopausal women with node-positive, hormone receptor-positive breast cancer. However, the decision to use the Oncotype DX test is one that you and your doctor should discuss and make together.
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Q: Can the Oncotype DX test be used for metastatic breast cancer?
A: The Oncotype DX test is not appropriate for women with metastatic breast cancer. The Oncotype DX test provides clinical experience information for use in women with certain types of invasive breast cancer.
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Q: Is the Oncotype DX test appropriate for use in women with DCIS or LCIS (carcinoma in situ)?
A: Yes. To Learn more about the Oncotype DX tests for breast and colon cancer patients, please visit: www.OncotypeDX.com
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Q: How do I get the Oncotype DX test?
A: 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 (lumpectomy or mastectomy). This means you do not have to undergo any additional surgery to have the Oncotype DX test.
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Q: How long will it take to get the test results of the Oncotype DX test?
A: It typically takes 10 to 14 calendar days from the date the tumor sample is received by Genomic Health for the results to be available. The Recurrence Score report form is sent to both the doctor treating you and the pathologist who submitted the tissue sample.
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Q: What is the difference between genetic tests (e.g., BRCA1 and BRCA2) and genomic tests (e.g., the Oncotype DX test)?
A: Genetic tests look at an individual's inherited traits or genes. Genomic tests look at groups of genes and how active they are. The Oncotype DX test looks at a panel of genes and their activity in breast tumor tissue within the cancer itself. This activity can influence how likely breast cancer is to grow and respond to treatment. The Oncotype DX test does not provide information about an individual's inherited genetic makeup. It provides information about the genomic activity of the tumor.
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Q: Where can I learn more about the Oncotype DX test?
A: To learn more about the Oncotype DX test, talk to your healthcare professional and care team. You can also visit www.oncotypedx.com.
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Q: Is the Oncotype DX test recommended by physicians?
A: The American Society for Clinical Oncology® (ASCO®) is an organization that develops recommendations for specific areas of cancer care. In 2007, ASCO experts indicated that the Oncotype DX test can be used for patients with node-negative, ER-positive breast cancer to identify:
  • Patients who may be successfully treated with tamoxifen alone and may not require adjuvant chemotherapy
  • Patients with a high risk of their cancer coming back, who might derive a greater benefit from specific regimens of adjuvant chemotherapy in addition to tamoxifen than from tamoxifen alone
National Comprehensive Cancer Network® (NCCN®) is an alliance of 21 of the world's leading cancer centers that creates clinical practice guidelines for use by clinicians, other healthcare practitioners, and their patients. Oncotype DX has also been included in the NCCN Breast Cancer Treatment Guidelines since 2008. Recognized as a standard of clinical care in oncology, NCCN Guidelines™ are comprehensive and frequently updated clinical practice guidelines. This inclusion reinforces the significance of molecular diagnostics in breast cancer treatment planning and, in particular, the value of the individualized information provided by Oncotype DX.

American Society of Clinical Oncology, ASCO, National Comprehensive Cancer Network, NCCN, and NCCN Guidelines are trademarks of ASCO and NCCN, respectively. ASCO and NCCN do not endorse any product or therapy.
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Q: What are the results of the Oncotype DX test?
A: The Oncotype DX test assigns a numerical value, which indicates the likelihood that a woman's cancer will return or recur (distant recurrence). That numerical value — the Recurrence Score result — also gives information about how likely the woman is to benefit from chemotherapy in addition to hormonal therapy. This test adds information beyond traditional factors such as tumor size, tumor grade, and the woman's age by looking at the biological makeup of her tumor. It is important to note that a low Recurrence Score result does not mean that there is no chance that a woman's breast cancer will return, and a high score does not mean that breast cancer will return. The Recurrence Score provides information about the likelihood of recurrence — it cannot determine with certainty whether breast cancer will or will not return.
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Q: Does the Oncotype DX test provide the information I need to decide whether to receive chemotherapy?
A: 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. In addition to assessing whether a woman's cancer is likely to come back, the Oncotype DX test provides insight into the amount of benefit that a woman will derive from undergoing chemotherapy in addition to hormonal therapy. You and your doctor should consider the Oncotype DX test results together with other findings, as well as your own personal preference, in determining which treatment plan is right for you.
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Q: Will the Oncotype DX results tell my doctor which treatment to use?
A: 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 breast cancer, but the test will not specifically identify which chemotherapy treatments to use. The results of the Oncotype DX test should be used with other diagnostic information to help you and your doctor with treatment planning.
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Q: Does the Oncotype DX test replace other laboratory tests?
A: No. The results of the Oncotype DX test are intended to be used together with the results of other laboratory tests that are performed to evaluate breast cancer.
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Q: Is the Oncotype DX test covered by insurance?
A: Most insurance carriers, including Medicare, Aetna, United Healthcare, and CIGNA, cover the Oncotype DX test for node-negative, estrogen receptor-positive, invasive breast cancer patients, but some carriers have yet to establish coverage policies. It is unknown at this time whether carriers will cover Oncotype DX for patients with node-positive breast cancer. The Genomic Access Program (GAP) helps you verify whether your insurance covers the test and, if so, helps obtain reimbursement. GAP is designed for women covered by a U.S. insurance company. GAP can assist you by:
  • Determining whether your insurance plan is likely to cover the Oncotype DX test
  • Obtaining prior authorization, if required
  • Processing your claim
  • Assisting through the appeals process if your claim is denied by your 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. For more information, please download a brochure that discusses the Oncotype DX test and GAP. You can also learn more about GAP here. To contact GAP, please call (866) ONCOTYPE (866-662-6897).
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Q: What if I don't have insurance or I am underinsured?
A: Genomic Health believes that every eligible woman 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 Genomic Health Customer Service at (866) ONCOTYPE (866-662-6897).
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Q: How do I qualify for the financial assistance plan?
A: Genomic Health understands that being financially responsible for some or all of the cost 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 Genomic Health Customer Service at (866) ONCOTYPE (866-662-6897).
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Q: Does Medicare cover the cost of the Oncotype DX test?
A: To learn about Medicare and insurance coverage, please visit: www.OncotypeDX.com  
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Q: What type of sample is needed to perform the Oncotype DX test?
A: The Oncotype DX process is performed using a very small sample of the tumor tissue that was removed during a woman's lumpectomy or mastectomy. This means that no additional surgery is needed for this test. In the United States, 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.
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Q: How is the tumor sample submitted for the Oncotype DX analysis?
A: Your doctor works with a pathologist, who is a specialist in diagnosis and tumor tissue analysis, to prepare a tissue specimen from the tumor that was removed during lumpectomy or mastectomy. The pathologist uses a special kit to submit the tumor sample to the Genomic Health Laboratory for analysis.
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The information presented on this site is intended to provide patients with newly diagnosed invasive breast cancer, as well as their friends and family, an opportunity to hear how others have incorporated the information provided by the Oncotype DX® Recurrence Score® in making treatment decisions with their doctors. The personal stories featured on this site selected by Genomic Health, Inc., which offers the Oncotype DX® test, are not intended to be representative of patients with breast cancer generally, and should not be considered medical advice. Patients should consult their doctor to determine the best treatment decision for their individual disease.

American Society of Clinical Oncology (ASCO) and ASCO are registered trademarks of ASCO; National Comprehensive Cancer Network (NCCN) and NCCN are registered trademarks of NCCN. ASCO and NCCN do not endorse any product or therapy.

Copyright © 2004-2012 Genomic Health, Inc. All rights reserved. Genomic Health, Oncotype, Oncotype DX, Recurrence Score, and Pass It On: Until Every Woman Knows are trademarks of Genomic Health Inc. MyBreastCancerTreatment.org is sponsored by Genomic Health, Inc., a clinical laboratory in Redwood City, California that developed and offers the Oncotype DX® Breast Cancer Assay. Genomic Health is responsible for the content of MyBreastCancerTreatment.org.