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REDWOOD CITY, Calif., March 20, 2017 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results from 15 Oncotype DX Breast Recurrence Score® studies conducted in 12 countries that provide real-world evidence of the test's ability to change treatment decisions in breast cancer patients. The new findings, presented at the 15th St. Gallen International Breast Cancer Conference in Vienna, demonstrate the economic value of the test across multiple healthcare systems and reinforce the clinical validation, accuracy and precision of the Breast Recurrence Score™ in various early-stage breast cancer patient populations, including those with node-positive disease.
"Precision medicine is no longer just a promise - it is a reality for the more than 700,000 cancer patients tested to date for whom Oncotype DX has individualized care based on the biology of their tumor," said Steven Shak, M.D., chief scientific officer, Genomic Health. "The extensive scientific evidence on the clinical and health economic value of the Oncotype DX Breast Recurrence Score is unsurpassed as evidenced by its inclusion in all major global guidelines. We look forward to the publication of the updated St. Gallen International Expert Consensus Panel report, which has recognized Oncotype DX as the leading test to guide chemotherapy decisions since 2011."
In addition, the American Joint Committee on Cancer (AJCC) recently incorporated the Oncotype DX test in its updated published Eighth Edition AJCC Cancer Staging Manual, identifying Oncotype DX as the only multi-gene test with Level I evidence to determine formal staging of breast cancer patients, based on prospective outcomes in more than 63,000 patients.
New data presented last week at the St. Gallen International Breast Cancer Conference include:
Three studies involving more than 8,000 node-positive breast cancer patients showed those with a low Oncotype DX Breast Recurrence Score (RS) had excellent outcomes at five years
Collectively, these results are consistent with two separate comprehensive reviews conducted by independent physician groups who have used the Oncotype DX Breast Recurrence Score in clinical practice when treating node-positive patients. A comprehensive summary led by Terry Mamounas M.D., M.P.H., FACS, UF Health Cancer Center in Orlando, Fla., included seven international studies involving more than 9,000 patients with node-positive disease. Additionally, Dr. Jeremy P. Braybrook, Bristol Cancer Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, U.K., reported a pooled analysis of international studies in 385 patients with one to three positive lymph nodes showed that testing with the Breast Recurrence Score significantly impacted treatment decisions (43 percent), resulting in a net reduction in chemotherapy use in real-world clinical practice.
Multiple studies from Germany and France reconfirm clinical and health economic value of Oncotype DX Breast Recurrence Score, supporting broader adoption of the test in Western Europe
These results are consistent with findings from a review of eight other international studies that included more than 2,500 patients and demonstrated that Breast Recurrence Score testing led to an approximate 40 percent reduction in chemotherapy use in node-negative breast cancer.
"These new findings, based on results from thousands of patients in the U.S. and Europe, provide more evidence of the value of Oncotype DX in deciding whether chemotherapy is needed or not for women with both node-negative and node-positive breast cancer," said professor Ian Smith, consultant medical oncologist, professor of cancer medicine, Royal Marsden Hospital, London. "This genomic test has already spared thousands of patients from unnecessary chemotherapy and reduced healthcare costs worldwide."
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. The company's flagship product, the Oncotype DX Breast Recurrence Score, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Breast DCIS Score™ predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. With more than 700,000 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 or www.MyBreastCancerTreatment.org.
About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that help optimize cancer care by addressing the overtreatment of the disease, 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 700,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid- and tissue-based tests, including the recently launched Oncotype SEQ® Liquid Select™. 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 applicability of clinical study results to actual outcomes; the impact of results from clinical studies on market adoption and utilization of Oncotype DX® tests, our ability to develop and commercialize new tests and expand into new markets domestically and internationally; unanticipated costs or delays in research and development efforts; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's quarterly report on Form 10-K for the year ended December 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, Genomic Health, Oncotype, Oncotype DX, Breast Recurrence Score, Recurrence Score, DCIS Score, Oncotype SEQ, Liquid Select, Genomic Prostate Score, Oncotype AR-V7 Nucleus Detect 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.
SOURCE Genomic Health, Inc.
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