What is the Oncotype DX^® test?
How does the Oncotype DX test work?
When should the Oncotype DX test be used?
What are the benefits of the Oncotype DX test?
Is the Oncotype DX test right for me?
Can the Oncotype DX test be used for metastatic breast cancer?
Is the Oncotype DX test appropriate for use in women with DCIS or LCIS (carcinoma
in situ)?
How do I get the Oncotype DX test?
How long will it take to get the results of the Oncotype DX test?
What are the results of the Oncotype DX test?
Does the Oncotype DX test provide the information I need to decide whether to receive chemotherapy?
Will the Oncotype DX results tell my doctor which treatment to use?
What type of sample is needed to perform the Oncotype DX test?
How is the tumor sample submitted for the Oncotype DX analysis?
Is the Oncotype DX test covered by insurance?
What if I don't have insurance or I am underinsured?
How do I qualify for the financial assistance plan?
Does Medicare cover the cost of the Oncotype DX test?
Does the Oncotype DX test replace other laboratory tests?
What is the difference between genetic tests (e.g., BRCA1 and BRCA2) and genomic tests (e.g., the Oncotype DX test)?
Where can I learn more about the Oncotype DX test?
Is the Oncotype DX test recommended by physicians?


Q: What is the Oncotype DX^® test?
A: The Oncotype DX test is a breast cancer assay that looks at the activity of 21 genes within a woman's tumor sample in order to provide an individual, numerical assessment of how likely breast cancer is to return. In addition, the Oncotype DX test provides information about how much benefit a woman is likely to get from chemotherapy (commonly used drugs in early-stage breast cancer) in addition to hormone therapy.

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Q: How does the Oncotype DX test work?
A: RNA, part of the makeup of your cells, is extracted from the tumor sample and then analyzed to determine the level of activity or expression of each of 21 genes. The results of the analysis are then put into a mathematical equation to convert those measures into the Recurrence Score^® result.

This result corresponds to the likelihood of breast cancer returning within 10 years of initial diagnosis (distant recurrence). The result also provides insight into the amount of benefit the woman may receive from undergoing chemotherapy (commonly used drugs for early-stage breast cancer) in addition to hormonal therapy.

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Q: When should the Oncotype DX test be used?
A: The Oncotype DX test is appropriate for newly diagnosed women whose disease meets the criteria below. You may wish to discuss with your physician whether Oncotype DX may be of benefit to you.

The Oncotype DX test is performed on tumor tissue removed during the original surgery. Because of this, the Oncotype DX test does not require additional surgery.

It is appropriate for your physician to order this test prior to starting a chemotherapy treatment regimen, since the information provided by the Oncotype DX test can help determine the most appropriate type of treatment for each woman's individual cancer.

If you do not know the stage of your breast tumor, or your estrogen receptor or nodal status, please check with your doctor and request a copy of your pathology report.

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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 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, 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. A recent study 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: No. The Oncotype DX test provides clinical experience information for women recently diagnosed with certain types of invasive breast cancer. DCIS and LCIS are not considered invasive breast cancer.

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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 the 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 results of the Oncotype DX test?
A: It will typically take 10 to 14 calendar days from the date the tumor sample is received by Genomic Health^® for the results to be available. The Oncotype DX report form is sent to both the doctor treating you and the pathologist who submitted the tissue sample.

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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: 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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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 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: The Medicare contractor responsible for processing claims submitted by Genomic Health has issued a coverage policy to cover the Oncotype DX test when used within six months of the original diagnosis for women with Stage I or II, estrogen receptor-positive, lymph node-negative breast cancer. This coverage policy applies to most Medicare beneficiaries who are eligible for the test. Currently, Medicare requires no co-payments for this type of testing. Therefore, when Medicare covers the test, the beneficiary has no financial obligation (unless the annual deductible applies).

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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: 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 group of 21 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 http://www.genomichealth.com/oncotype/pathome.aspx.

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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

The 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 2008 Breast Cancer Treatment Guidelines. 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.

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