REDWOOD CITY, Calif., June 8, 2016 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today 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:
- 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 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.
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
Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of cancer, one of the greatest issues in healthcare today. With its Oncotype IQ™ Genomic Intelligence Platform, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic big data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DX gene expression tests that have been used to guide treatment decisions for more than 600,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid and tissue-based tests. The company is based in Redwood City, California, with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.
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 Securities and Exchange Commission, including the risks set forth in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2016. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score, DCIS Score, Oncotype SEQ, and Oncotype IQ are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.
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SOURCE Genomic Health, Inc.