Genomic Health Announces Presentation of Three Oncotype DX® Studies at the 8th European Breast Cancer Conference

GENEVA, March 21, 2012 /PRNewswire/ --

Results Reconfirm Test's Cost-Effectiveness, Emphasise Important Role in Guiding Treatment Decisions

Genomic Health, Inc. (Nasdaq: GHDX) today announced results of three new Oncotype DX^® studies including data demonstrating the test's cost-effectiveness within the German and Hungarian healthcare systems, and Israeli data showing the test's impact on treatment decisions in early-stage invasive breast cancer patients with lymph-node positive status. These findings will be presented during poster sessions at the 8^th European Breast Cancer Conference (EBCC) in Vienna, Austria, March 21-24.

"We now have eight clinical studies involving more than 5,000 patients across Europe, showing the value the Oncotype DX test brings to patients, physicians and payors," said Christer Svedman, director, medical affairs in Europe, Genomic Health.  "As international use of the Oncotype DX breast cancer test increases, it's important to not only have strong clinical data but also to demonstrate that using the test is cost effective in different healthcare systems."

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. Multiple studies conducted in Germany, Spain, the United Kingdom, Israel, Japan, Australia, and the United States have shown the use of the test to change treatment decisions in approximately 30 percent of patients. Additionally, nine health economic analyses have consistently demonstrated the cost effectiveness of Oncotype DX in the assessed healthcare systems in Europe, Asia, Israel and North America.  

Health Economics Analyses in Germany and Hungary Demonstrate Oncotype DX's Cost Effectiveness

"As physicians, we are challenged to provide quality patient care while exercising economic sense. Oncotype DX is a unique tool we can use to help guide treatment recommendations for early-stage breast cancer patients in a cost effective manner," said Wolfgang Eiermann, M.D., professor of gynecology, Interdisciplinary Oncology Center, Munich, Germany.  "Oncotype DX is already included in international clinical guidelines such as ESMO, St. Gallen, ASCO and NCCN^[1] and our research demonstrates that Oncotype DX is cost effective and impacts treatment decisions ensuring that the right patients benefit from chemotherapy, while others are spared unnecessary treatment and associated toxicities."

• The results of a large prospective German multicenter study involving 366 patients have shown that use of the Oncotype DX changed initial recommendations in 33 percent of cases and demonstrate that using the test would be associated with an increased survival and be cost effective in Germany. "Using the 21-gene breast cancer assay in adjuvant decision-making in ER-positive (ER+) early breast cancer (EBC) is cost-effective: Results of a large prospective German multicenter study" (Abstract #302) will be presented on Friday, March 23.

• Additionally, a health economics analysis from Hungary finds the Oncotype DX compares favourably with other oncology related health technologies being utilised in the country and that using the Oncotype DX assay is likely to be cost effective in Hungary.  "The impact of chemotherapeutic regimens on the cost-utility analysis of Oncotype DX assay" (Abstract #347) will be presented on Thursday, March 22.

Using Oncotype DX in Lymph Node-Positive Patients in Israel is Likely to Reduce Use of Chemotherapy

• In an evaluation of the relationship between the Recurrence Score^® results and treatment decisions in patients with oestrogen receptor-positive, node-positive, breast cancer in Israel, researchers found that patients who had the Oncotype DX test were less likely to be recommended chemotherapy compared to patients who did not have the test even when adjusting for variables such as grade and nodal status (p<0.001). The study included 282 patients who received the Recurrence Score and 669 control patients who did not receive the test. "Recurrence Score (RS) and treatment decisions in node-positive (N+), oestrogen receptor-positive (ER+) breast cancer patients in Israel" (Abstract #433) will be presented on Friday, March 23.

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is a global cancer company focused on the development and commercialisation of genomic-based clinical laboratory services that analyse the underlying biology of cancer allowing physicians and patients to make individualised 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 invasive breast cancer and has been shown to the predict the likelihood of recurrence in ductal carcinoma in situ (DCIS).   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, 2011, more than 10,000 physicians in over 65 countries had ordered more than 265,000 Oncotype DX tests.  Genomic Health has a robust pipeline focused on developing tests to optimise the treatment of prostate and renal cell cancers, as well as additional treatment decisions in breast and colon cancers.  In February, the company announced plans to form a new wholly owned genetics subsidiary to focus on the commercial applications of the human genome, with the goal of making commercial services available to physicians and patients in 2013.  The company is based in Redwood City, California with European headquarters in Geneva, Switzerland.  For more information, please visit, http://www.GenomicHealth.com.  To learn more about Oncotype DX tests, visit: http://www.OncotypeDX.com and http://www.mybreastcancertreatment.org. 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to; the cost effectiveness of Oncotype DXwithin the German and Hungarian healthcare systems; the ability of the company's tests to optimise cancer treatment and  impact clinical practice; value the company's tests are delivering to physicians, payers and patients; the applicability of cost effectiveness study results to actual outcomes; the impact of clinical and cost effectiveness studies on the use of the company's tests; the ability of the company to successfully market its products outside of the US; the ability of the company to develop additional tests in the future; the scope, success or results of clinical trials and the timing of such activities; and, the ability of the company's tests to be adequately reimbursed. 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 results of clinical and cost effectiveness studies; the applicability of clinical study results to actual outcomes; the risks and uncertainties associated with the regulation of the company's tests by the FDA or similar agencies around the world; our ability to develop and commercialise new tests; unanticipated costs or delays in research and development efforts; our ability to obtain and maintain reimbursement coverage for our tests 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 period ended December 31, 2011. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

^[1]ESMO, ASCO and NCCN are registered trademarks of the European Society of Medical Oncology, the American Society of Clinical Oncology and National Comprehensive Cancer Network, respectively.  ESMO, St Gallen, ASCO and NCCN do not endorse any product or therapy.

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SOURCE Genomic Health