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Nature Partner Journals Publish Five-year Outcomes Results from SEER Registry Demonstrating Oncotype DX® Accurately Identifies Early-stage Breast Cancer Patients with Excellent Survival
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,
Additional Highlights from Nature Partner Journals Publication of SEER-NCI Study:
- Mortality significantly increased with increasing Breast Recurrence Score results (p < 0.001) in both node-negative and node-positive disease;
- Among node-positive patients, 57 percent had Breast Recurrence Score results < 18, 36 percent had results 18-30, and 7 percent had results > 31, reinforcing the wide range of tumor biology revealed by Oncotype DX in node-positive disease; and
- Multiple analyses showed definitively (p < 0.001) that Oncotype DX provided clinically important information on prospective patient outcomes beyond standard measures.
"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
The publication follows the recent presentation of four new analyses of the SEER Registry presented at the 2016
About Oncotype DX®
The Oncotype DX® portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. With more than 600,000 patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeDX.com, www.mybreastcancertreatment.org and www.myprostatecancertreatment.org.
About Genomic Health
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: our business model; the regulation of our tests; the applicability of clinical study results to actual outcomes; our ability to develop and commercialize new tests and expand into new markets domestically and internationally; the risk that we may not obtain or maintain sufficient levels of reimbursement, domestically or abroad; competition; unanticipated costs or delays in research and development efforts; our ability to obtain capital when needed; and the other risks and
uncertainties set forth in our filings with the
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