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Last updated on April 23, 2014 at 10:40 EDT

Genomic Health Announces Colon Cancer Publication Supporting Wider Oncotype DX® Utilization

November 5, 2013

Current Medical Research & Opinion Publishes Positive Decision Impact Study Demonstrating Significant Impact on Colon Cancer Treatment Recommendations

REDWOOD CITY, Calif., Nov. 5, 2013 /PRNewswire/ — Genomic Health, Inc. (Nasdaq: GHDX) today announced that Current Medical Research & Opinion (CMRO) published positive results from the Partnership for Health Analytic Research (PHAR) clinical utility analysis of the Oncotype DX(®) colon cancer test, demonstrating that use of the assay changes treatment recommendations in 29 percent of stage II colon cancer patients.

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“We now have eight peer-reviewed publications that reinforce the value Oncotype DX provides to physicians, colon cancer patients and our healthcare system,” said Steven Shak, M.D., executive vice president of research and development, Genomic Health. “With clinical studies involving more than 5,000 patients and three clinical utility studies demonstrating significant impact on outcomes and treatment recommendations, we believe there will be expanded support for broader private reimbursement and increased patient access to our Oncotype DX colon cancer test.”

The PHAR clinical decision impact survey of physicians who ordered the Oncotype DX colon cancer test showed that knowledge of a patient’s Recurrence Score(®) is associated with changes in the medical oncologists’ treatment recommendations in 29 percent of cases. Two-thirds (67 percent) of changes in treatment recommendations were decreases in treatment intensity (changes from chemotherapy to observation or from oxaliplatin-containing chemotherapy to treatment with fluoropyrimidine monotherapy), while one-third (33 percent) of changes were increases in treatment intensity.

“In the past, selection of stage II patients for chemotherapy treatment following surgery has been based on a limited set of clinical and pathologic markers that are uninformative for most patients,” said Thomas H. Cartwright, M.D., Florida Cancer Affiliates, Ocala, Florida, and the principal investigator of this study. “The Oncotype DX colon cancer test has been clinically validated to provide a quantitative, individualized Recurrence Score and has been very helpful in treatment planning. The test represents an important advancement in bringing personalized medicine into today’s clinical setting to benefit patients.”

To read the publication titled “Effect of the 12-Gene Colon Cancer Assay Results on Adjuvant Treatment Recommendations in Patients with Stage II Colon Cancer,” visit: http://www.cmrojournal.com

Separately, the Journal of Clinical Oncology accepted for publication positive results from the third successful validation of the Oncotype DX colon cancer test in patients with stage II disease and first validation study in patients with stage III disease. Presented at the 2012 European Society for Medical Oncology Congress, these findings demonstrate that incorporation of the Recurrence Score may better inform adjuvant therapy decisions for certain patients with stage III disease, as well as those with stage II colon cancer.

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is the world’s leading provider of genomic-based diagnostic tests that address the overtreatment 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 throughout the cancer patient’s journey, from screening and surveillance, to diagnosis, to 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 DXprostate cancer test, which predicts disease aggressiveness in men with low risk disease. As of June 30, 2013, more than 19,000 physicians in over 70 countries had ordered more than 375,000 Oncotype DX tests. The company is based in Redwood City, California with European headquarters inGeneva, 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 the potential of the company’s colon cancer test to change medical practice in the treatment of stage II colon cancer; the ability of test to reduce the use of chemotherapy and the direct medical costs associated with treating colon cancer for patients with stage II colon cancer; the applicability of the company’s colon cancer test to stage III colon cancer patients; the ability of the company to secure additional reimbursement for its colon cancer test; the applicability of study results to clinical practice; the ability of the company the timing and results of future studies or clinical trials; the focus and attributes of the company’s product pipeline; the ability of the company to develop additional tests in the future; and the ability of any potential tests the company may develop to optimize cancer treatment. 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 breast, colon and prostate cancer tests; 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 and uncertainties associated with regulation of the company’s tests by the FDA and other regulatory organizations; the company’s ability to compete against third parties; the company’s ability to develop and commercialize new tests; the company’s ability to use next generation sequencing methods to discover and develop novel biomarkers; unanticipated costs or delays in research and development efforts; the company’s ability to successfully commercialize its tests outside of the United States; 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 June 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, OncotypeDX, 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