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Last updated on April 23, 2014 at 1:22 EDT

Genomic Health Announces Publication of Second Positive Validation of Oncotype DX Colon Cancer Test Confirming Its Value Beyond Conventional Markers

April 17, 2013

Findings of CALGB 9581 Published in the Journal of Clinical Oncology Support Expansion of Colon Cancer Reimbursement and Broader Patient Access



REDWOOD CITY, Calif., April 17, 2013 /PRNewswire/ — Genomic Health, Inc. (Nasdaq: GHDX) today announced that the Journal of Clinical Oncology (JCO) published positive results from the large CALGB 9581 clinical validation study of the Oncotype DX® colon cancer test in stage II colon cancer patients. The findings provide further confirmation that the Oncotype DX Recurrence Score® (RS) results improve the ability to differentiate high recurrence risk disease from low, beyond conventional factors such as T-stage, mismatch repair (MMR) status, nodes examined, grade and lymphovascular invasion.

“This collaboration reinforces the importance of working together to evaluate the relevance of new technologies in the care of colon cancer patients,” said Alan P. Venook, M.D., The Madden Family Distinguished Professor of Medical Oncology and Translational Research, Gastrointestinal Oncology Research Program, University of California, San Francisco, and lead investigator of the study. “The Oncotype DX test provides independent information regarding individual tumor biology, which can yield a different overall risk assessment in a subset of cases. This enhances our ability to identify the most appropriate treatment plan for each stage II colon cancer patient, potentially sparing them from chemotherapy they do not need.”

Supporting the findings of the original validation of the Oncotype DX colon cancer test in the QUASAR study, the newly published results represent an examination of patients with low to intermediate risk stage II colon cancers from the CALGB 9581 phase III clinical trial. In this study, the Recurrence Score result was the strongest predictor of recurrence risk, providing risk discrimination beyond conventional clinical and pathologic measures in multivariable analyses. The Recurrence Score result was particularly valuable in patients with T3 stage and intact (proficient) mismatch repair (MMR) protein function, a population for whom conventional factors are uninformative. In this group of patients, the Recurrence Score result identified 22 percent of patients with an average risk of recurrence at five years above 20 percent. A high colon cancer Recurrence Score result reveals an underlying biology indicative of more aggressive disease for which adjuvant chemotherapy may be more appropriately considered.

“Publication of these data, our second major clinical validation study for the Oncotype DX colon cancer test, marks an important milestone in bringing the benefits of genomics to newly diagnosed colon cancer patients,” said Steven Shak, M.D., chief medical officer and executive vice president of research and development at Genomic Health. “Since Oncotype DX provides the biological understanding necessary to accurately distinguish patients with a lower risk of recurrence from those with high-risk disease, we expect that this publication will accelerate our momentum toward gaining greater acceptance among treating physicians and reimbursement by payors.”

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 19,000 physicians in over 70 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 colon cancer test to further differentiate high recurrence risk disease from low risk disease; 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 potential of the company’s test to change medical practice in the treatment of stage II colon cancer; 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: 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-K for the quarter ended December 31, 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.


Source: PR Newswire