Genomic Health, Inc. announced that new data presented at the 16th St.Gallen International Breast Cancer Conference in Vienna reinforce the utility of the Oncotype DX Breast Recurrence Score® test to optimize chemotherapy recommendations in patients with early-stage breast cancer with or without lymph node involvement. The important role of genomic testing to optimize patient outcomes in early-stage breast cancer was discussed in a debate between leading international breast cancer specialists during the St. Gallen Conference. The experts presented several case studies showing that genomic testing adds value beyond clinical pathological factors, and they agreed that there are substantial differences between the available tests. An updated analysis of the Clalit Health Services registry, the larger health services organization in Israel, was presented at the Conference. This analysis examined the medical records of more than 1,300 patients with node-negative breast cancer applying the Recurrence Score cut point determined by the landmark TAILORx study. The findings showed that use of chemotherapy was aligned with Oncotype DX test results and that patients with Recurrence Score results up to 25, the vast majority of whom were treated with hormonal therapy alone, had excellent outcomes at 10 years, with low rates of distant recurrence. Also presented at the Conference was real-world evidence from a study in more than 80,000 patients, based on an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) registry program of the National Cancer Institute (NCI). The findings confirmed that the Recurrence Score result is predictive of chemotherapy benefit in patients with node-negative disease (p=0.009), with no chemotherapy benefit in patients with Recurrence Score results up to 25. In patients with node-negative disease and Recurrence Score results up to 25 not treated with chemotherapy, the Breast Cancer Specific Survival (BCSS) was greater than 98% at nine years. In patients with node-positive disease not treated with chemotherapy and Recurrence Score results less than 18, BCSS was greater than 97% at nine years. Importantly, this real-world evidence reinforces the paradigm established by the TAILORx study, which provided definitive information on how to treat women with node-negative early-stage breast cancer based on their Recurrence Score results. TAILORx, the largest randomized adjuvant breast cancer treatment trial ever conducted, identified the vast majority of women who receive no substantial benefit from chemotherapy, as well as the important minority for whom chemotherapy can be life-saving. Results of two decision impact studies from the UK and the Czech Republic, highlighting the value of Oncotype DX to personalize and improve the quality of clinical decisions, also were presented at the Conference. In the UK study, clinical practice results from 582 patients with node-positive disease (one to three positive lymph nodes) showed that chemotherapy recommendations changed in a significant proportion of patients following testing with Oncotype DX. In particular, the test allowed more than 60% of patients to be spared chemotherapy and its associated short- and long-term side-effects. Conversely, the test identified 23 patients who were initially advised to undergo only endocrine therapy, but whose treatment was changed to add chemotherapy based on their Recurrence Score result. Without testing, these patients would not have received potentially life-saving chemotherapy treatment.