Genomic Health Presents Twenty Two International Studies Demonstrating Worldwide Adoption and Value of Oncotype DX® Breast Cancer Test

REDWOOD CITY, Calif. and ST. GALLEN, Switzerland, March 15, 2013 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced the presentation of results from 22 studies at the 13^th St. Gallen International Breast Cancer Conference highlighting the impact of the Oncotype DX® breast cancer test around the world.  New data continue to demonstrate the test's ability to change treatment decisions and provide economic value across multiple health care systems, while reinforcing its clinical validation, accuracy and precision.  This unparalleled number of studies and consistency of results emphasize the benefit that the Oncotype DX test provides in breast cancer as the only genomic test shown to predict chemotherapy benefit. 

"Our extensive, unsurpassed body of clinical evidence showcases Oncotype DX's unique ability to play a critical role in breast cancer treatment, while providing a positive impact on health systems worldwide, at this time when societies are seeking value from their healthcare spending," said Steven Shak, M.D., chief medical officer and executive vice president of research and development, Genomic Health.  "The volume of the high quality research presented at this major international breast cancer conference reflects our leadership in utilizing genomics to personalize breast cancer treatment and Oncotype DX's unique ability to accurately assess whether ER positive breast cancer patients will benefit from chemotherapy."

Multiple Studies Continue to Reinforce Oncotype DX Test is the Only Genomic Test to Predict Chemotherapy Benefit

"The Oncotype DX Recurrence Score was developed to answer the specific question of which estrogen receptor positive breast cancer patients - representing 75 percent of all breast cancer diagnoses - need chemotherapy in addition to hormonal therapy," said William C. Wood, M.D., member of the St. Gallen International Breast Cancer Expert Panel, professor of surgery, Emory University School of Medicine and joint professor of global health, Rollins School of Public Health.  "To date, it is the only test validated for this purpose, and future validation of other genomic tests should be held to the same rigorous standard for accurate interpretation so that results from all genomic tests can be clearly understood for treatment decision making."

• An analysis of 67 patients comparing their Oncotype DX Recurrence Score result and the MammaPrint 70 gene test showed that the two tests classified patients differently in a large proportion of patients. Specifically, the results found that 45 percent of patients defined as high risk by the MammaPrint test actually had low risk Oncotype DX Recurrence Score® results, indicating these patients would have minimal, if any, benefit from chemotherapy, and these patients, based on estrogen receptor expression, would be expected to have a large benefit from hormonal therapy alone.  Additionally, MammaPrint failed to provide results in 15 percent of the samples, whereas Oncotype DX analysis successfully delivered Recurrence Score results for all the samples.  Importantly, these results confirm an earlier study by investigators independent of Genomic Health that was presented at the American Society of Clinical Oncology (ASCO) Breast Symposium in 2011, where 39 percent of patients classified as high risk by MammaPrint were reclassified as low risk by Oncotype DX. 

"This discordance clearly emphasizes some of the limitations of the 70 gene test in terms of clinical decision making. The test was developed based on small, non-randomized studies that used largely untreated patient cohorts that do not reflect the established standard of care," said Norman Wolmark, M.D., chairman of the National Surgical Adjuvant Breast and Bowel Project, USA. "In contrast, the Oncotype DX test was developed in a patient population receiving standard of care hormonal therapy which allowed the validation of the relative therapeutic benefit of adding chemotherapy.  Clearly, all multi-gene tests are not the same with respect to their development, validation or clinical utility."

A summary of clinical evidence for the Oncotype DX test involving 5,854 patients identified six unique prospectively-designed studies of archived samples that met the strict definition of clinical validation, reinforcing that the Oncotype DX test is the only genomic assay to meet level 1B evidence (Simon RM, Paik S, and Hayes DF. JNCI 2009) for clinical use in early-stage, hormone-receptor positive, invasive, breast cancer patients.  Additionally, this analysis includes 11 supportive studies.

Decision Impact Data from France, Germany, Israel, Spain, the United Kingdom and United Arabic Emirates Show Oncotype DX Changes Physician Treatment Recommendations

• An analysis of previous prospective decision impact studies from France, Germany, Spain and the United Kingdom (UK) involving 527 early-stage invasive breast cancer patients with node-negative disease show that the Oncotype DX test changes treatment decisions in more than 31 percent of patients. Within those changes, 48 percent of patients originally recommended chemotherapy went on to receive to hormone therapy alone, while 18 percent of patients originally recommended endocrine treatment alone added chemotherapy to their hormonal treatment after having the assay result.  These new results confirm that knowledge of the Recurrence Score result has a significant impact on treatment recommendations with an overall reduction in chemotherapy use. 

Additionally, a study from the United Arab Emirates showed that using the test was associated with as significant change in treatment, and a study from Israel demonstrated that patients with intermediate Recurrence Score results have treatment recommendations changes as well, reflecting patient's individual biology and emphasizing the importance of an independent score that represents the continuous nature of cancer biology.  These results support 15 previously reported Oncotype DX clinical utility studies from Europe, Australia, Canada, Israel, Japan, Mexico and the United States.

Five Health Economic Analyses from France, Hungary, Ireland, Mexico and the Netherlands Demonstrate Oncotype DX is Cost Effective, Delivers Significant Healthcare Savings

• A study analyzing the real life budget impact associated with one year of using the Oncotype DX test among 342 patients in Ireland, where the test is publicly reimbursed in patients with early-stage, ER positive, HER2 negative breast cancer, delivered an estimated 856,440 euro in savings for the Health Service Executive, the public healthcare services system in Ireland.
• A study from France estimates that the use of the Oncotype DX test to guide chemotherapy decisions would save more than 5 million euro by sparing patients from unnecessary chemotherapy.  These results underline potential significant cost savings if the test would be reimbursed in France.
• Three studies from Mexico, the Netherlands and Hungary demonstrate that the use of the Oncotype DX test is expected to be cost effective in their countries, adding to the growing body of evidence of more than 20 studies emphasizing the health economic value of the test across multiple systems.

"Based on the growing body of evidence illustrating the clinical and economic value of Oncotype DX for patients and physicians across healthcare systems in Europe, it is important that more patients get access to this test to help determine whether they should receive adjuvant chemotherapy treatment," said Dr. Catherine M. Kelly, M.D., consultant medical oncologist, Mater Misericordiae University Hospital and University College Dublin, Ireland.

Additional Results Continue to Reinforce Oncotype DX Provides Important Individualized Information Not  Available through Traditional Measures Alone and Include the Following Data Highlights:

• A large study of 1,065 early-stage, node-positive, estrogen receptor positive breast cancer patients treated with anthracycline containing chemotherapy (AC) plus hormonal therapy as part of the NSABP B-28 trial supported that the Oncotype DX Recurrence Score is a robust predictor of distant recurrence, disease-free survival, overall survival, and loco-regional recurrence in this patient population.
• Two studies showed a wide range of Recurrence Score results within the luminal A and B subtypes reinforcing that the individual Recurrence Score cannot be predicted by the luminal subtype, immunohistochemistry, or traditional clinical and pathologic measures.  These data include a retrospective analysis of all breast cancer patients who underwent the Oncotype DX testing through Clalit Health Services in Israel and the West German Study Group's large study where the Oncotype DX test was included as a treatment decision tool in more than 2,500 patients.

In addition to the studies highlighted above, Genomic Health also presented positive results from nine other studies including:

• "Concordance of HER2 testing by IHC/FISH and RT-PCR in ER negative/borderline Early-stage Breast Cancer Patients"
• "Family life during and after breast cancer treatment: A European patient survey"
• "Oncotype DX vs. clinicopathologic factors in beast cancer: The experience from Greece and Cyprus"
• "Quantitative gene expression by RT-PCR in classic and variant lobular carcinoma in ER+ breast cancer"
• "Quantitative gene expression by RT-PCR in the special histologic subtypes of invasive breast cancer"
• "Using the Recurrence Score in clinical practice: An HMO experience with a unified testing policy"
• "The Oncotype DX DCIS Score and quantitative gene expression for ER, PR, and HER2"
• "The development of the DCIS Score: scaling and normalization in the Marin General population"
• "ADAPT - Adjuvant Dynamic marker-Adjusted Personalized Therapy trial-optimizing risk assessment and therapy response prediction in early breast cancer"

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is a global healthcare company that provides actionable genomic information to personalize cancer treatment decisions.  The company's 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 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 multi-gene expression test developed for the assessment of risk of recurrence in patients with stage II and stage III disease.  As of December 31, 2012, more than 10,000 physicians in over 65 countries had ordered approximately 335,000 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 treatment decisions in 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.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 ability  of the  company's Oncotype DX test to change medical practice in the treatment of invasive breast cancer and DCIS;  ability of the test to impact treatment decisions in a clinical setting  outside of the United States; the ability of test to reduce the use of chemotherapy and the direct medical costs associated with treatment; the ability of the test to be cost savings in healthcare systems outside of the United States; the ability of the company to obtain and maintain reimbursement for its products outside of the United States; the  company's belief that it is positioned to lead the delivery of new genomic tests that improve patient outcomes; the attributes and focus of the company's product pipeline; the applicability of clinical study results to actual outcomes; the potential economic benefits associated with the company's tests; the ability of the company to develop additional tests in the future; and the demand for the company's 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 applicability of clinical study results to actual outcomes; the risks and uncertainties associated with possible additional regulation of the company's tests both in the United States and abroad; the availability and extent of reimbursement coverage; risks associated with the commercialization of current and future tests; the risks associated with competition; unanticipated costs or delays in research and development efforts; 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 September 30, 2012. 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, Recurrence Score, and DCIS 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.