Genomic Health Announces Presentation of Five Studies in Breast and Colon Cancers at the 2011 European Multidisciplinary Cancer Congress

Findings Reconfirm Healthcare Cost-Effectiveness, Underscore Value of Tumor Biology to Guide Treatment Decisions, Expanding Evidence that Support Worldwide Use of Oncotype DX®

Sep 13, 2011, 08:00 ET from Genomic Health, Inc.

REDWOOD CITY, Calif., Sept. 13, 2011 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results of five studies covering breast and colon cancers that will be presented during poster sessions at the 2011 European Multidisciplinary Cancer Congress, September 23-27, in Stockholm, Sweden.

Breast cancer presentations include health economics analysis of seven studies in six countries supporting Oncotype DX's cost effectiveness across various healthcare systems. Breast cancer data also includes a study from Japan reconfirming that use of Oncotype DX reduces use of chemotherapy in early-stage breast cancer patients, including those with lymph node positive status. Additionally, studies from Israel and Greece reinforce prior findings that the Oncotype DX Recurrence Score® (RS) cannot be predicted by traditional clinicopathologic measures.

The company also will present results across multiple clinical endpoints from a second large study of the Oncotype DX Colon Cancer test confirming its ability to predict recurrence risk for stage II colon cancer, providing information not available with conventional prognostic factors.

"As international use of the Oncotype DX breast cancer test increases and our research continues to consistently demonstrate its economic value and clinical utility across multiple healthcare systems, we believe there is opportunity for additional patients around the world to benefit from the test," said Christer Svedman, director, medical affairs in Europe, Genomic Health. "Additionally, results from a second large study in colon cancer reinforce the critical roles of the Oncotype DX Recurrence Score and mismatch repair (MMR) to guide more personalized treatment of patients with stage II colon cancer."

Breast Cancer Presentations Include Studies in Italy, Japan, Israel and Greece:

Health Economics Analyses in Six Countries Supports Oncotype DX's Cost Effectiveness in Various Settings, Regardless of Local Clinical Practices

"Oncotype DX is used widely in the U.S. and I believe it will increasingly be incorporated into clinical care in Europe as well, based on the St. Gallen Panel's recent decision to include the test in its breast cancer guidelines, combined with the consistent health economic data illustrating Oncotype DX's cost effectiveness," said Paolo Pronzato, MD, The National Institute for Cancer Research, Genova, Italy. "By providing additional information to help physicians tailor treatment to the individual patient, Oncotype DX consistently has been shown to help save healthcare costs across multiple countries and healthcare systems. Regardless of their country of residence, appropriate early-stage breast cancer patients should have access to Oncotype DX."

  • A review of seven cost-effectiveness studies published in six countries demonstrates consistent findings that using the Oncotype DX assay is cost-effective in these markets, and in some markets even estimated to be cost saving. "Is the 21-gene breast cancer test (Oncotype DX®) good value for money?" (Abstract #5194) will be presented on September 25, 2011.

Oncotype DX Reduces Use of Chemotherapy in Treatment of Lymph Node-Negative and Lymph Node-Positive Breast Cancer Patients in Japan

  • Preliminary data based on the first 90 patients from a multi-center study in Japan demonstrates that using the Oncotype DX Breast Cancer test reduces chemotherapy treatment by 25 percent in 73 patients with lymph node-negative disease and 71 percent in 17 patients with lymph node-positive disease. "Decision Impact and Economic Evaluation of the 21-gene Recurrence Score (RS) Assay for Physicians and Patients in Japan" (Abstract #5161) will be presented on September 25, 2011.

Traditional Clinicopathologic Variables Cannot Predict Breast Cancer Recurrence Score

  • An analysis of 2,477 patients in Israel with ER-positive, HER2 normal breast cancer, including 308 patients with one to three positive nodes and 305 patients with micrometastases, concludes that the Recurrence Score result cannot be predicted by traditional clinicopathologic measures, such as patient age, tumor grade, tumor size, progesterone receptor status or tumor marker Ki67. Patients covered by Clalit Health Services and Maccabi Health Services in Israel, who received the Oncotype DX Breast Cancer tests between January 2008 and June 2010, showed a range of Recurrence Score biology across all subgroups defined by patient age, tumor size, grade, PR and Ki-67 as well as nodal status. "Evaluation of Recurrence Score, node status and traditional clinicopathologic metrics in a large ER-positive cohort (Abstract #1420) will be presented on September 26, 2011.

Recurrence Score Reconfirms the Importance of Tumor Biology Guiding Breast Cancer Treatment Decisions

  • The findings of a retrospective analysis of treatment decision changes in 101 breast cancer patients in Greece who were being considered for treatment with hormonal therapy alone, demonstrate that use of Oncotype DX resulted in a decision to add chemotherapy in 28.7 percent of the women. "Clinical use of Oncotype DX Recurrence Score as an Adjuvant-Treatment Decision Tool in Early Breast Cancer Patients" (Abstract #5165) will be presented on September 25, 2011.

"Identification of patients who, without Oncotype DX testing, might have not received potentially life-saving chemotherapy treatment based on their traditional pathological factors, underscores the test's vital role in guiding treatment decisions based on a patient's individual tumor biology," said principal investigator of the study, Christos Markopoulos, MD, PhD, professor at the Athens University Medical School in Greece.

Colon Cancer Presentation:

Large Colon Cancer Clinical Study Confirms Strong Association of RS, MMR and Patient Outcomes

  • Results of the second large clinical validation study of stage II colon cancer patients enrolled in CALGB 9581 confirms the QUASAR clinical validation study presented at ASCO in 2009 demonstrating the importance of Recurrence Score and MMR in stage II colon cancer. Analysis of 690 stage II colon cancer patients showed 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. Recurrence Score and mismatch repair deficiency (MMR-D) were most strongly associated with recurrence-free interval (RFI), a clinical outcome measure directly reflecting tumor biology and clinical aggressiveness. "Endpoints for validation of tumor markers for recurrence risk: Recurrence-free interval (RFI), disease-free survival (DFS), overall survival (OS), and colon-cancer specific survival (CCSS) in CALGB 9581" (Abstract #1411) will be presented on September 26, 2011.

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 recurrence in early-stage breast cancer to help optimize treatment options. 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.(1) The test is also recognized in international guidelines issued by St. Gallen International Breast Cancer Expert Panel and European Society for Medical Oncology (ESMO). Physicians also use Oncotype DX to make treatment recommendations for 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.

The Oncotype DX Colon Cancer test is the first multigene expression test commercially available that has been clinically validated to predict risk of recurrence in patients with stage II colon cancer. Genomic Health collaborated with the National Surgical Adjuvant Breast and Bowel Project and Cleveland Clinic on a total of four development studies in more than 1,800 to analyze patients with stage II colon cancer. The final gene panel was then independently evaluated in more than 1,400 stage II colon cancer patients in the QUASAR validation study.

As of June 30, 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: www.oncotypedx.com and www.untileverywomanknows.com.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including  the ability of the company's tests to impact clinical practice, statements relating to our ability to generate similar results in further studies; the clinical utility of our tests; 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 market acceptance in Europe or elsewhere of our tests. 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.

(1) ASCO and NCCN are registered trademarks of the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN), respectively. ASCO and NCCN do not endorse any product or therapy

SOURCE Genomic Health, Inc.



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