The Oncotype DX breast cancer test examines the activity of 21 genes in a patient’s breast tumor tissue to provide personalized information for tailoring treatment based on the biology of their individual disease. The test is supported by multiple rigorous clinical validation studies confirming the test’s ability to predict the likelihood of chemotherapy benefit as well as the chance of cancer recurrence in early-stage breast cancer. The test is intended for use in all newly diagnosed patients with early-stage (stage I, II or IIIa), breast cancer who have node-negative or node-positive (1-3), estrogen receptor-positive (ER+), HER2-negative disease.
As the only test proven to predict chemotherapy benefit, the Oncotype DX test is included in all major cancer guidelines worldwide and now considered as standard of care for women with early-stage breast cancer with unprecedented prospective patient 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. Further, in the largest randomized adjuvant breast cancer treatment trial ever conducted, the TAILORx trial definitively identified the 70% of women with intermediate-range Oncotype DX scores who will not benefit from chemotherapy, and the 30% for whom chemotherapy can be life-saving. Genomic Health now has an unparalleled amount of new invasive breast cancer evidence demonstrating that Oncotype DX has clinical utility both by changing treatment decisions and by delivering favorable prospective patient outcomes worldwide regardless of age, tumor size or grade in early-stage patients with ER-positive, invasive breast cancer.
With the increasing prevalence of ductal carcinoma in situ (DCIS), there is a significant unmet need to determine which women with this Stage 0 pre-invasive cancer are at high risk of having their cancer return, either as DCIS or as an invasive carcinoma. The Oncotype DX breast cancer test for DCIS patients is the first and only clinically validated genomic test to provide an individualized prediction of the 10-year risk of local recurrence (either DCIS or invasive carcinoma). This diagnostic test helps guide treatment decision-making in women with DCIS treated by surgery, with or without hormone therapy.
The Oncotype DX test for DCIS provides information in addition to standard measurements (such as margin width, tumor size and tumor grade) that doctors have traditionally used to estimate how likely a patient’s cancer is to return, and to help doctors and patients optimize treatment decisions.