CHICAGO, June 4, 2011 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results of ten studies being presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, including a second large validation study confirming the performance of the Oncotype DX® colon cancer Recurrence Score® (RS) as an independent predictor of recurrence risk in stage II colon cancer. The company also will present positive findings from a prostate gene identification study, as well as multiple studies in breast cancer including one suggesting that neoadjuvant treatment selection can also be guided by the underlying biology revealed by the Oncotype DX breast cancer test.
"Our continued research in breast, colon and prostate cancers add to the growing body of clinical evidence demonstrating the importance of understanding and treating a patient's underlying individual tumor biology," said Steven Shak, M.D., chief medical officer at Genomic Health, "These ten studies presented at ASCO reflect our ability to continue adding value to the Oncotype DX breast and colon cancer tests that physicians use today, while accelerating our prostate cancer clinical development program, with the goal of making a test for biopsy specimens available to patients and physicians in 2013."
Second Successful Prospectively-Designed Study Confirms Oncotype DX Colon Cancer Test Provides Value Beyond Conventional Markers
Supporting the original QUASAR study presented at ASCO in 2009, new results from a separate large clinical validation study of stage II colon cancer patients enrolled in CALGB 9581 further confirms that the Oncotype DX Recurrence Score result improves the ability to differentiate higher from lower recurrence risk beyond conventional factors, such as tumor grade, number of nodes examined and lymphovascular invasion. Among patients with T3 stage II colon cancers with intact mismatch repair (MMR) protein function for whom conventional factors are uninformative, the Recurrence Score identified 22 percent of patients with an average risk of recurrence at 5 years above 20 percent providing an ability to accurately discriminate recurrence risk not available with conventional prognostic factors. A high colon cancer Recurrence Score reveals an underlying biology indicative of more aggressive disease for which adjuvant therapy may be more appropriately considered.
"These results, emphasizing Oncotype DX's precision, reproducibility and standardization, reinforce the potential value the test can provide for the large subset of stage II colon cancer patients who have T3 tumors which are MMR proficient," said Alan P. Venook, M.D., professor of clinical medicine, Gastrointestinal Oncology Research Program, University of California, San Francisco, and lead investigator of the study. "Acquiring better understanding of the biology of an individual patient's disease enhances my ability to identify the most appropriate treatment plan for each patient, potentially sparing them from chemotherapy they do not need."
The study, "Validation of a 12-gene colon cancer recurrence score (RS) in patients (pts) with stage II colon cancer (CC) from CALGB 9581" (Abstract #3518) will be presented during a poster discussion on Monday, June 6.
Gene Identification Results Support Development of a Prostate Cancer Test to Distinguish Indolent vs. Aggressive Disease
"This year, more than 200,000 men are expected to be diagnosed with prostate cancer, but few will benefit from aggressive treatments," said Eric Klein, M.D., chairman of the Glickman Urological and Kidney Institute at the Cleveland Clinic in Cleveland, Ohio. "If physicians had a better tool for more accurately determining whether or not a patient's disease is clinically significant, many men could avoid radiation therapy or surgery, as well as common treatment-related side effects such as loss of sexual function and incontinence."
Results of a quantitative RT-PCR analysis of RNA specimens from 441 prostate cancer patients treated with radical prostatectomy (RP) at Cleveland Clinic between 1987 and 2004 identified 295 genes strongly associated with clinical cancer recurrence following radical prostatectomy. The study, "Quantitative gene expression in primary and highest Gleason pattern cancer specimens identifies genes associated with clinical recurrence and prostate cancer -- specific survival after radical prostatectomy" (Abstract #4663) will be presented on Sunday, June 5.
A separate analysis of RNA from the same specimens indicated that there is no association of expression of TMPRSS2-ERG fusions or ERG expression with aggressiveness of prostate cancer after RP. The study, "Use of TMPRSS2-ERG gene rearrangement and quantitative ERG expression to predict clinical recurrence after radical prostatectomy" (Abstract #4541) will be presented during a poster discussions session on Saturday, June 4.
"This new analysis in the Canadian healthcare system reinforces evidence from multiple countries that use of the Oncotype DX assay to predict recurrence and response to adjuvant chemotherapy for women with early stage breast cancer provides good value for money," said John Hornberger, MD, MS, CEO, Cedar Associates and Adjunct Professor of Medicine, Stanford. "Appropriate use of a clinically validated test that uncovers underlying biology that cannot be predicted by traditional clinical-pathologic measures, such as Oncotype DX, is clearly where clinical science needs to go. Economic policies should welcome and encourage these developments."
Oncotype DX Breast Cancer Saves Healthcare Costs in Canada
Neoadjuvant Treatment Should be Guided by the Underlying Biology Revealed by the Oncotype DX Breast Cancer Test
Breast Cancer Recurrence Score Cannot Be Predicted by Traditional Clinicopathologic Measures
Additional Breast Cancer Studies Expand Understanding of Tumor Biology
About Genomic Health and the Oncotype DX® Tests
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 risk for disease recurrence in early-stage breast cancer. The test is also validated for use in certain node-positive breast cancer patients. 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. Oncotype DX is the only test incorporated in published ASCO® and NCCN® breast cancer treatment guidelines* for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive.
The Oncotype DX colon cancer test is the first multigene expression test commercially available that has been clinically validated to predict risk for disease recurrence in patients with stage II colon cancer. Five studies involving more than 3,200 patients have been conducted to validate the Oncotype DX colon cancer test.
As of March 31, 2011, more than 10,000 physicians in over 60 countries had ordered more than 200,000 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. To learn more about Oncotype DX tests, visit:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to our ability to generate similar results in further studies; the clinical utility of preliminary biomarkers for a prostate cancer test; our ability to develop and launch a test for prostate cancer in 2013; the ability of the company to develop additional tests in the future; the ability of any tests the company may develop to optimize cancer treatment; the scope, success or results of clinical trials and the timing of such activities; the applicability of clinical study results to actual outcomes; and the ability of the company's tests to impact clinical practice. 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 possible additional regulation of our tests both in the United States and abroad; the risks associated with competition; the applicability of clinical study results to actual outcomes; the risks associated with the commercialization of current and future products; the risks that our products may infringe the intellectual property of third parties; the risks and potential delays associated with such studies; 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-Q for the quarter ended March 31, 2011. 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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