The Oncotype DX Test: Essential Genomic Information for Improving Your Treatment Decision for Early-Stage Invasive Breast Cancer

What: The Oncotype DX Breast Recurrence Score test is a unique genomic test that helps women recently diagnosed with early-stage invasive breast cancer. The test generates a score of 0-100 based on 21 specific genes in your breast tumor tissue that was removed during surgery. This unique set of genes predicts your response to chemotherapy as well as the chances of your cancer returning to provide personalized information that is not available from any other test or measure.

To date, the Oncotype DX test has been ordered in over 90 countries for over 900,000 patients.

Benefit: For early-stage invasive breast cancer (Stage I-IIIa), the Oncotype DX test can tell you the likelihood that you may benefit from chemotherapy, as well as the chances of your breast cancer returning (recurrence). 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.

Surgery to remove tumor
Doctors orders the Oncotype DX test
Hospital sends sample of tumor to the Exact Sciences laboratory
The Exact Sciences laboratory analyzes the 21 genes
Doctor receives the Recurrence Score result
Doctor and patient discuss the results and personalize treatment

: The Oncotype DX test is performed on the tumor tissue sample previously obtained during your original surgery 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 Recurrence Score 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 Exact Sciences laboratory.

Evidence:  The Oncotype DX Breast Recurrence Score 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).

As the only test proven to predict chemotherapy benefit, the Oncotype DX test is now considered as standard of care for women with early-stage breast cancer with unprecedented evidence outcomes in more than 63,000 patients from four large, independently run, international studies. These positive results from the SEER Registry, TAILORx, Clalit and West German Group’s Plan B studies demonstrate that Oncotype DX accurately predicts patient outcomes – including risk of recurrence and breast cancer survival. The studies showed that 99% of those with low Oncotype DX scores who were primarily treated using hormonal therapy alone, WITHOUT chemotherapy, were cancer free after 5 years.

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.