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
- Multiple Countries: In a meta-analysis of nine published decision impact studies with a total of 1,154 early-stage breast cancer patients, the RS result led to an approximately 35 percent change in treatment decisions. The overall reduction of chemotherapy recommendations or use was approximately 24 percent. The study, "Meta-analysis of the Decision Impact of the 21-Gene Breast Cancer Recurrence Score in Clinical Practice," will be presented on Thursday, March 17.
- Germany: Results from 149 early-stage breast cancer patients with node negative disease and 48 patients with node positive disease in Germany showed that the use of the RS result can have an impact on adjuvant treatment decision making. Specifically, based on the RS result, the adjuvant treatment recommendation changed in 38 percent of node negative cases and in 48 percent of node positive cases. Knowledge of the RS result led to a change from chemotherapy plus hormonal therapy to hormonal therapy alone more commonly than from hormonal therapy alone to the addition of chemotherapy. Overall, there was a 17 percent reduction in the use of chemotherapy after Oncotype DX testing. The study, "German Multicentre Decision Impact Study of Oncotype DX Recurrence Score on Adjuvant Treatment in Estrogen Receptor Positive Node Negative and Node Positive Early Breast Cancer," will be presented on Thursday, March 17.
- Spain: Results from a prospective multicenter study of 107 early-stage Spanish breast cancer patients demonstrated that the use of the Oncotype DX test changed the adjuvant treatment recommendation in approximately 32 percent of patients and that physician confidence in the treatment recommendations increased in 60 percent of cases. The results also provided evidence on how Oncotype DX and traditional pathological factors are complementary in supporting change in treatment recommendations. The study, "Prospective trans-GEICAM Study of the Impact of the 21-Gene Recurrence Score Assay and Traditional Clinico-Pathological Factors on Clinical Decision Making in Women with Estrogen Receptor-positive, HER2-negative, Node-negative Breast Cancer," will be presented on Thursday, March 17.
- United Kingdom: Results based on an analysis of Oncotype DX in 107 early-stage breast cancer patients in the UK demonstrate a reduction in the use of adjuvant chemotherapy in 14 percent of patients and a change in treatment recommendations in 33 percent of cases. Additionally, researchers found that the RS can provide UK physicians and patients with additional prognostic information beyond that currently provided by the Nottingham Prognostic Index (NPI), the current decision aid frequently used to make adjuvant breast cancer treatment decisions in the region. The researchers concluded that the results suggest that it is applicable and feasible to perform in the UK setting with a reduction in the use of adjuvant chemotherapy consistent with the findings of other reported studies. The study, "Results from a Prospective Clinical Study on the Impact of Oncotype DX on Adjuvant Treatment Decision and Risk Classification by Nottingham Prognostic Index (NPI) and Recurrence Score (RS)" will be presented on Thursday, March 17.
"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
- Greece: In a study of 42 patients, the RS result reclassified the assessment of risk and likelihood of chemotherapy benefit in more than half of patients compared to the traditional criteria. The study reinforces that clinicopathologic or guideline criteria for categorizing patients does not predict the RS from the 21-gene Oncotype DX assay. The study, "Impact of the 21-gene Recurrence Score Assay on Treatment Decision in Early Breast Cancer (EBC) Patients with Favorable Prognostic Factors," will be presented on Thursday, March 17.
- Japan: Results from a study of 142 patients demonstrated that conventional pathological factors are not equivalent to the use of the RS in the treatment decision making process for early-stage breast cancer patients in Japan. The correlation of the RS with a variety of individual markers was poor to moderate. The researchers suggest that tumor genomic expression provides unique information for prognostic and predictive assessment and, in particular, that the RS cannot be predicted by individual or composite clinicopathologic markers. The study, "The Possibility of Replacing the 21-Gene Signature by Conventional Pathological Factors for Hormone Receptor Positive Breast Cancer Patients," will be presented on Thursday, March 17.
Oncotype DX Provides Cost-Saving Benefits in Greece, Singapore and Hungary
- Greece: Results showed that the use of the Oncotype DX breast cancer test during the treatment decision-making process in early-stage breast cancer patients would be expected to be cost saving in Greece. The study, "Gross Financial Evaluation of the Application of the 21-Gene Assay Oncotype DX for Adjuvant Chemotherapy Decision-Making in Estrogen Receptor-Positive Node-Negative Breast cancer in Greece," will be presented on Thursday, March 17.
- Singapore: Based on a validated Markov model to calculate the cost and quality of life gained, this study found that for women with early-stage breast cancer in Singapore, the RS result can be a cost-saving treatment decision tool that favorably affects the lives of patients. The study, "Cost-benefit Analysis of a 21-Gene Recurrence Score for Early Stage Breast Cancer in Singapore," will be presented on Thursday, March 17.
- Hungary: Results demonstrated that the use of the Oncotype DX breast cancer test in early-stage breast cancer patients in Hungary can have a positive impact on a patient's quality of life, while also demonstrating favorable cost-effectiveness. Researchers concluded that Oncotype DX is a cost-effective methodology in the Hungarian setting. The study, "Evaluation of the cost-effectiveness of Oncotype-DX® multigene assay in Hungary," will be presented on Thursday, March 17.
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.