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Genomic Health Announces Colon Cancer Publication in Journal of Clinical Oncology Supporting Wider Oncotype DX® Utilization

November 13, 2013

Journal of Clinical Oncology Publishes Positive Results from Third Successful Validation in Stage II Colon Cancer, First Validation in Patients with Stage III Disease

REDWOOD CITY, Calif., Nov. 13, 2013 /PRNewswire/ — Genomic Health, Inc. (Nasdaq: GHDX) today announced that the Journal of Clinical Oncology (JCO) has published positive results from a large, independent validation study of the Oncotype DX(®) colon cancer test in patients from the National Surgical Adjuvant Breast and Bowel Project (NSABP) C-07 clinical trial. The results provide further confirmation that the Oncotype DX Recurrence Score(®) (RS) results predict recurrence risk and provide additional information beyond conventional risk factors, enabling better discrimination of absolute benefit of chemotherapy as a function of risk. Patients with a high Recurrence Score result can be expected to derive larger absolute chemotherapy treatment benefit than patients with a low Recurrence Score result in both stage II and stage III colon cancer.

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“The Recurrence Score result has shown us that there is a continuous biology in colon cancer versus a high or low ranking,” said principal investigator Michael O’Connell, M.D., associate chairman of the NSABP. “This critical understanding of where a patient falls on that continuum is going to help both stage II and stage III colon cancer patients and their physicians make more informed decisions regarding adjuvant therapy.”

This large, independent validation study involved 892 patients and demonstrated that the Oncotype DX colon cancer Recurrence Score results predict risk of recurrence, disease-free survival and overall survival in stage II and stage III colon cancer patients receiving adjuvant chemotherapy (all p<0.001). This is the third successful prospectively-designed study of the Oncotype DX colon cancer test in patients with stage II disease and the first validation study in patients with stage III disease, and it represents the ninth peer-reviewed publication reinforcing the value of the Oncotype DX colon cancer test for physicians, colon cancer patients and our healthcare system. The results add to the growing body of clinical evidence, in a suite of studies, with more than 5,000 patients supporting its clinical validity and impact on chemotherapy treatment decisions.

“Genomic Health continues to expand the body of evidence to address the clinical needs for the more than 20,000 stage II and stage III colon cancer patients diagnosed each year in the United States alone,” said Steven Shak, M.D., executive vice president of research and development, Genomic Health. “With our third published validation study, we continue to demonstrate that our test provides important quantitative and individualized risk assessment that helps guide chemotherapy treatment planning and enables precision medicine.”

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is the world’s leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early stage cancer, one of the greatest issues in healthcare today. The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient’s journey, from screening and surveillance, through diagnosis, treatment selection and monitoring. Genomic Health’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, and the Oncotype DX prostate cancer test, which predicts disease aggressiveness in men with low risk disease. As of September 30, 2013, more than 19,000 physicians in over 70 countries had ordered nearly 400,000 Oncotype DX tests. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth. To learn more about OncotypeDX tests, visit: www.OncotypeDX.com, www.mybreastcancertreatment.org and www.myprostatecancertreatment.org.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to ability of the company’s colon cancer test to differentiate high recurrence risk disease from low risk disease; the ability of test to inform the use of chemotherapy in treating colon cancer for patients with stage II and stage III colon cancer; the potential of the company’s test to change medical practice in the treatment of stage II and stage III colon cancer the applicability of clinical study results to actual outcomes; the ability of the company’s tests to impact clinical practice; and the focus and attributes of the company’s product pipeline. the success or results of clinical trials and the timing of such activities; 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: risks related to the success of the company’s colon cancer test; the company’s ability to increase usage of its tests; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks associated with competition;; the risks and uncertainties associated with regulation of the company’s tests by the FDA and other regulatory organizations; ; the company’s history of operating losses; the results of clinical 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2013. 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.

Source: PR Newswire