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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.

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