Frequently Asked Questions
Below are answers to frequently asked questions about the Oncotype DX® test.
The Oncotype DX test is a breast cancer test that looks at the activity of 21 genes within a woman's tumor sample in order to provide an individual probability of the likelihood of breast cancer returning in women with early-stage breast cancer whose tumor is estrogen-receptor-positive and lymph-node-negative or in post-menopausal women whose tumor is lymph-node-positive and hormone-receptor-positive. 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.
For additional information about the Oncotype DX test, click here.
Women with newly diagnosed estrogen-receptor-positive (ER+), lymph-node-negative, stage I or II breast cancer may be eligible. Post-menopausal women recently diagnosed with node-positive, estrogen-receptor-positive breast cancer may also be appropriate candidates for the Oncotype DX test. For more information, click here.
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) among women with early stage, estrogen-receptor-positive and lymph-node-negative breast cancer who are taking hormone therapy. 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".
Women who have the Oncotype DX test performed receive a report with a number called a Recurrence Score result. The Recurrence Score result is a number calculated from expression levels of 21 genes within that patient’s tumor—16 cancer-related genes and 5 control genes. A Recurrence Score result can, along with other information, help a woman and her doctor determine whether or not to include chemotherapy in her treatment plan. It can also shed some light on the chance that the cancer will come back in the future.
Insurance carriers covering most of the U.S. population, 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 the Oncotype DX test for patients with node-positive breast cancer. Genomic Health has a program called the Genomic Access Program (GAP) that can help you verify whether or not your insurance covers the test and, if so, can help you obtain reimbursement. Genomic Health also has a financial assistance program. For more information, visit our Insurance Information section.
Yes, Medicare covers claims submitted by Genomic Health when used within six months of the original diagnosis for women with stage I or II, estrogen-receptor-positive, lymphnode-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). For additional information regarding insurance coverage call 866-ONCOTYPE (866-662-6897).
The Oncotype DX test is performed on tissue removed during your initial surgery (lumpectomy or mastectomy). Like any laboratory test, the Oncotype DX test must be ordered by an authorized healthcare provider such as your surgeon or oncologist. For more information on getting tested, including information regarding talking to your doctor about the Oncotype DX test, click here.
It typically takes 10 to 14 calendar days to receive the Oncotype DX test results. Results will be sent to the doctor treating you and the pathologist who submitted the sample.
In addition to the information available on this website, patients and caregivers can visit MyTreatmentDecision.com, a website dedicated to helping guide your early breast cancer treatment decisions. You can also visit the Genomic Health website, or contact Genomic Health directly at 866-ONCOTYPE (866-662-6897) or customerservice@genomichealth.com.