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Oncotype DX® Changes Treatment Decisions in 45 Percent of Stage II Colon Cancer Patients

May 2, 2014

Large Study Published in The Oncologist Underscores Test’s Value in Guiding Treatment Decisions

REDWOOD CITY, Calif., May 2, 2014 /PRNewswire/ — Genomic Health, Inc. (Nasdaq: GHDX) today announced that The Oncologist published positive results from an Oncotype DX(®) colon cancer decision impact study, demonstrating that Recurrence Score(®) results changed treatment recommendations in 45 percent of stage II colon cancer patients. The study was conducted in collaboration with the Mayo Clinic Cancer Research Consortium.

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“The benefit of adjuvant chemotherapy in stage II colon cancer patients–particularly those without traditional high-risk features–remains unclear,” said Steven Alberts, M.D., chair of Medical Oncology at the Mayo Clinic, Rochester, Minn. “By utilizing Oncotype DX, we are able to reduce the variability and subjectivity associated with defining recurrence risk, thereby improving the treatment paradigm.”

This prospective study evaluated 141 stage II colon cancer patients from 17 sites in the Mayo Clinic Cancer Research Consortium. For each patient, the physician’s recommended postoperative treatment plan of observation or chemotherapy was recorded before and after the Recurrence Score results were provided.

Treatment intensity decreased for 33 percent of patients (from chemotherapy to observation or from oxaliplatin-containing to non-oxaliplatin-containing regimens) and increased for more than 11 percent of patients (from observation to any chemotherapy or from non-oxaliplatin-containing to oxaliplatin-containing treatment). Overall, physician recommendations for chemotherapy decreased by 22 percent.

A health economic analysis of these findings indicates that treatment decisions based on incorporation of the Oncotype DX colon cancer test would be expected to result in an improvement in patient outcomes and cost savings to the healthcare system.

“With seven clinical studies involving more than 3,500 patients, we continue to demonstrate how the Oncotype DX colon cancer test provides practice-changing genomic information to enable more informed cancer treatment decisions,” said Phil Febbo, M.D., chief medical officer, Genomic Health.

The results were published online in advance of the print issue and can be accessed at the following link:
https://theoncologist.alphamedpress.org/content/early/2014/04/05/theoncologist.2013-0401.full.pdf+html

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 December 31, 2013, more than 19,000 physicians in over 70 countries had ordered approximately 420,000 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 demand for our Oncotype DX Breast Cancer test in Europe; the advantages of the Oncotype DX Breast Cancer test over other tests in guiding the use of chemotherapy in early-stage breast cancer treatment; the applicability of study results to actual outcomes; the ability of the company’s tests to impact clinical practice; the ability of the company to develop and commercialize additional tests in the future; the attributes of the company’s product pipeline; and the scope, 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: 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 breast 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 Annual Report on Form 10-K for the period ended December 31, 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.

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SOURCE Genomic Health, Inc.


Source: PR Newswire



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