February 7, 2014

Genomic Health Announces Results of Oncotype DX(R) Colon Cancer Studies Presented at 2014 American Society of Clinical Oncology Gastrointestinal Cancer (ASCO GI) Symposium

By Anonymous User

New data show real-life impact of Oncotype DX on treatment decisions, underscore clinical validity and utility of the test

REDWOOD CITY, Calif., Jan. 29, 2014 /PRNewswire/ — Genomic Health, Inc. (Nasdaq: GHDX) today announced results from the Oncotype DX® colon cancer test studies that were recently presented at the 2014 American Society of Clinical Oncology Gastrointestinal Cancer Symposium (ASCO GI).  Presentations highlighted the robust body of clinical evidence for the Oncotype DX colon cancer test and its real-life impact on patient and physician treatment decisions, underscoring the practice-changing value of this test.

Prospective study demonstrated real-life impact on physician and patient treatment decisions

Through an analysis of physician recommendations and patient treatment preferences before and after receiving the Oncotype DX colon cancer test results, this study demonstrated that the test greatly increased concordance between physician and patient treatment choice (from 66 percent to 96 percent).  Furthermore, the evaluation showed that the quantitative information provided by the Recurrence Score® result influenced a majority of patients’ treatment decisions (85 percent) and physicians’ treatment recommendations (69 percent), and it increased physicians’ confidence in their own recommendations (84 percent).  Patients’ anxiety was also significantly reduced, which may improve adherence to their treatment plan and ultimately lead to better health outcomes.

“The additional information provided by the Oncotype DX test enables me and my patients to make better informed decisions about their individual treatment,” said Steven Alberts, M.D., chair of the Division of Medical Oncology at Mayo Clinic Cancer Center, Rochester, Minn.  “The test also helps patients gain greater confidence in the prescribed course of treatment, which is key to achieving optimal health results.”

Robust data shows Oncotype DX meets tumor marker level I evidence for clinical use in colon cancer

The review of four validation studies of the Oncotype DX colon cancer test, which included a total of 3,315 patients with early stage colon cancer, consistently demonstrated a significant association (p < 0.05) between the test results and recurrence risk and cancer-specific survival.  Based on these results, the Oncotype DX colon cancer test meets level I evidence criteria, underscoring the test’s clinical value beyond traditional clinicopathologic variables such as age, tumor size, tumor grade, number of nodes examined or evidence of lymphovascular invasion.  Additionally, three decision impact studies with a total of 502 patients showed that the test changed treatment recommendations in 29 to 45 percent of stage II colon cancer cases, leading to a net reduction in adjuvant chemotherapy use.  This analysis included previously-presented positive results by Partnership for Health Analytic Research, a multi-center study conducted in collaboration with the Mayo Clinic Cancer Research Consortium and a study conducted by Clalit Health Services in Israel.

“Over the last decade, Genomic Health has demonstrated that the rigorous validation of genomic information can transform cancer treatment,” said Phil Febbo, M.D., chief medical officer, Genomic Health. “As we mark the 10th anniversary of the first Oncotype DX test, we continue to apply our world-class science to usher genomic data into practice-changing results for patients living with breast, colon, and prostate cancer worldwide.”

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 the potential of the company’s colon cancer test to change medical practice; the ability of test to influence physicians treatment recommendations and patients treatment decisions and potentially improve adherence to selected treatment plan; the ability of the 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 ability of the company to develop additional tests in the future; the size of markets and demand for the company’s tests; and the company’s ability to commercialize new tests and expand into new markets domestically and internationally. 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 study results to clinical practice; 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 the company’s currently offered  tests, including its colon cancer test, and any potential tests the company may develop to optimize cancer treatment; 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; 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.

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Tags: Adjuvant (I-III, A-C) Colon Cancer, Colon Cancer, News Tips and Features, News Tips and Features Other, Screening/Prevention Colon Cancer, Stage IV (D)/Relapsed Colon Cancer