REDWOOD CITY, Calif. and ST. GALLEN, Switzerland, March 17, 2011 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results from nine studies utilizing the Oncotype DX® test in early-stage breast cancer patients at the 12th Annual St. Gallen International Breast Cancer Conference in St. Gallen, Switzerland. The studies included region-specific decision impact data that demonstrated the knowledge of a patient's Recurrence Score® (RS) result changed physicians' treatment recommendations in approximately 33 percent of cases in the United Kingdom (UK), Germany and Spain, which is similar to what has been shown in United States. Health economic data that illustrated the cost effectiveness of utilizing the RS result in Greece, Hungary and Singapore were also presented.
"We have now presented or published results from 11 decision impact studies conducted in five countries that emphasize the independent value of the Recurrence Score to identify which early-stage breast cancer patients can use hormonal therapy alone and forego chemotherapy, as well as those who should also be treated with chemotherapy," said Steven Shak, chief medical officer at Genomic Health. "The consistency of these results demonstrating that the Oncotype DX breast cancer test changes treatment decisions in approximately a third of cases, combined with positive cost-effectiveness analyses, supports our efforts to gain broad public reimbursement coverage for the test and expand this critical service to breast cancer patients worldwide."
The Oncotype DX breast cancer test measures the expression of 21 genes of an individual breast cancer tumor to generate a RS that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for early-stage patients. The test was launched in the United States in 2004 where it has been widely adopted for guiding treatment decisions in early-stage breast cancer and incorporated in published guidelines of leading cancer organizations. Oncotype DX is available for use worldwide and, as of December 31, 2010, more than 10,000 physicians in more than 60 countries had ordered more than 190,000 Oncotype DX tests.
"Oncotype DX provides a fundamental change in our therapy policy, representing a step towards more personalized medicine in Europe," said Wolfgang Eiermann, Professor of Gynecology and Medical Director, Red Cross Women's Hospital Munich. "Based on these data, there is a clear need for Oncotype DX to be included in daily clinical practice."
Oncotype DX Changes Physician Treatment Recommendations in Germany, Spain and the UK
"Results from our study involving leading physicians in the United Kingdom, combined with the other research presented at the St. Gallen Conference, support the clinical utility of the Oncotype DX breast cancer test in early-stage breast cancer patients throughout multiple regions in the world," said Simon Holt, MA, MB, BChir, FRCS, Lead Breast Surgeon, Hywel Dda NHS Trust Board, Wales, UK. "By providing further insight into the underlying tumor biology of breast cancer, the Recurrence Score gives me greater confidence in selecting the most appropriate treatment option based on that patient's individual disease."
Oncotype DX Impacts Physician Assessments in Greece and Japan
Oncotype DX Provides Cost-Saving Benefits in Greece, Singapore and Hungary
About the Oncotype DX® Breast Cancer Test*
The Oncotype DX breast cancer test is a multigene expression test that examines a breast cancer patient's tumor tissue at a molecular level, and gives information about their individual disease to help optimize treatment options. Oncotype DX is the only test incorporated in published ASCO® and NCCN® breast cancer treatment guidelines to predict the likelihood of chemotherapy benefit as well as recurrence for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive.
Additionally, physicians use Oncotype DX to make treatment recommendations for certain node-positive breast cancer patients, and the test report also provides quantitative scores for select individual genes. Oncotype DX has been extensively evaluated in thirteen clinical studies involving more than 4,000 breast cancer patients worldwide, including a large validation study published in The New England Journal of Medicine and a chemotherapy benefit study published in the Journal of Clinical Oncology. Both Medicare and private health plans covering over 95 percent of U.S. insured lives provided reimbursement for Oncotype DX for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive through contracts, agreements or policy decisions. For more information about Oncotype DX for breast cancer, please visit www.oncotypedx.com or www.untileverywomanknows.com.
*ASCO® is a registered trademark of the American Society of Clinical Oncology. NCCN® is a registered trademark of the National Comprehensive Cancer Network. ASCO and NCCN do not endorse any product or therapy.
About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is a molecular diagnostics company focused on the global development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients to make individualized treatment decisions. Its lead product, the Oncotype DX® breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multigene expression test developed for the assessment of risk of recurrence in patients with stage II disease. As of December 31, 2010, more than 10,000 physicians in over 60 countries had ordered more than 190,000 Oncotype DX tests. Genomic Health has a robust pipeline focused on developing tests to optimize the treatment of prostate and renal cell cancers, as well as additional stages of breast and colon cancers. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit www.genomichealth.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the belief that the Oncotype DX is significant in changing treatment decisions in early stage breast cancer; the company's belief that the Oncotype DX cannot be predicted by other factors such as age or individual biomarkers; the company's belief that the Oncotype DX is cost effective; the company's belief that it has the opportunity to advance the quality of cancer treatment decisions; the company's ability to continue adding value to its tests while advancing its product pipeline ; the company's belief that its research and pipeline reflect its ongoing commitment to develop and deliver tools to individualize cancer treatment decisions; the belief that study data may warrant or result in additional clinical studies or impact treatment decisions; and the applicability of clinical study results to actual outcomes. 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: the risks and uncertainties associated with the regulation of the company's tests; the impact of competition, the results of clinical studies; the results of cost effectiveness studies; the applicability of clinical study results to actual outcomes; 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 Annual Report on Form 10-K for the year ended December 31, 2010 . 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 and Recurrence Score 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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