Five years of results demonstrate Oncotype DX® accurately identifies early-stage breast cancer

June 8, 2016 – REDWOOD CITY. Genomic Health, Inc. announced the publication of results from the National Cancer Institute’s (NCI) Surveillance, Epidemiology, and End Results (SEER) Registry in Nature Partner Journals Breast Cancer, a peer-reviewed journal published by Nature. Published results demonstrated, based on evidence from over 44,600 breast cancer patients, that the Oncotype DX® Breast Recurrence Score™ accurately predicts survival outcomes in patients with node-negative and node-positive disease in contemporary “real-world” clinical practice.

Representing the largest report of prospective clinical outcomes in patients treated based on Oncotype DX, the results in more than 40,000 patients with node-negative disease and more than 4,600 patients with node-positive (up to 3 nodes) breast cancer showed that, among those with Breast Recurrence Score results less than 18, breast cancer-specific mortality (BCSM) at five years was 0.4 percent in those with node-negative disease and 1.0 percent in those with node-positive disease. These findings provide reassurance that these patients can be effectively treated with hormonal therapy alone without chemotherapy.

“Newly published results from the SEER Registry are consistent with the clinical validation studies, and confirm and extend the outcomes results from three other recent studies: TAILORx, Clalit Health Services and PlanB,” said Steven Shak, M.D., chief scientific officer, Genomic Health. “With unprecedented survival evidence from multiple large international studies in more than 50,000 patients, Oncotype DX should be recommended and used as standard-of-care in node-negative disease and in certain patients with node-positive disease.”

Additional Highlights from Nature Partner Journals Publication of SEER-NCI Study:

“The results of this study demonstrate the potential of future data linkages to enhance the quality, completeness and usefulness of the SEER data in supporting cancer research and our broadening understanding of the disease,” said Lynne Penberthy, M.D., M.P.H., associate director of the Surveillance Research Program, NCI’s Division of Cancer Control and Population Sciences.

The publication follows the recent presentation of four new analyses of the SEER Registry presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting. Additional data reconfirmed that Oncotype DX was an accurate predictor of five-year breast cancer survival in patients with node-positive and node-negative disease.

SOURCE Genomic Health, Inc.