Oncotype DX: Essential Genomic Information for Improving Your Treatment Decision

What:  The Oncotype DX breast cancer test is a unique genomic test that helps women recently diagnosed with either early-stage invasive breast cancer or DCIS (non-invasive) breast cancer. The test looks at the activity of certain genes in your breast tumor tissue to provide personalized information that is not available from any other test or measure.

To date, the Oncotype DX test (for both breast cancer and colon cancer) has been ordered by more than 10,000 doctors in over 70 countries for nearly half a million women.

Benefit:  Along with the information in your pathology report and other factors, your Oncotype DX test results can help you and your doctor determine the most appropriate treatment options for you based on the biology of your individual cancer.

  • If you have DCIS (Stage 0), the Oncotype DX test can help to predict whether your cancer may come back in the same breast (local recurrence) – a key factor in deciding your treatment following DCIS surgery.

Breast Cancer

  The Oncotype DX test is performed on the tumor tissue sample previously obtained during your original surgery (mastectomy, lumpectomy or core biopsy.)  You will not have to go through any additional surgery or procedure to get the Oncotype DX test.

When: It is important that your doctor request the Oncotype DX breast cancer test before you start any treatment, since the test results are intended for use in guiding the selection of your treatment.  Most test results are available within 7 to 10 days from the date your tumor sample is received by the Genomic Health laboratory.

Evidence:  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 to patients with breast cancer. 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).

It is also the only genomic breast cancer test with prospective outcomes data in more than 5,700 patients, providing real-life evidence for the impact Oncotype DX has on patients’ clinical results. These prospective data are based on three large international studies including the first results in low recurrence score patients from TAILORx (the Trial Assigning IndividuaLized Options for Treatment (Rx)), which is the largest ever adjuvant breast cancer trial. Sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), TAILORx is the first and only prospectively conducted clinical trial in which patients were uniformly treated based on a genomic test. The study showed that 99% of women with low Oncotype DX Recurrence Score results were free of cancer recurrence after five years.1

To date, more than 170,000 breast cancer patients have changed their treatment decision based the Oncotype DX test. Many of these women who received high Oncotype DX scores were able to choose chemotherapy as a potentially life-saving treatment, while the majority were able to effectively pursue hormonal therapy alone and avoid the unnecessary side-effects of chemotherapy.


1. Sparano et al. New Engl J Med. 2015. Prospective Validation of 21-Gene Expression Assay in Breast Cancer