Genomic Health Announces Positive Topline Results of Second Large, Independent Validation Study of Oncotype DX® in DCIS Breast Cancer

June 11, 2014

Complete Data to be Submitted for Presentation at the 2014 San Antonio Breast Cancer Symposium

REDWOOD CITY, Calif., June 11, 2014 /PRNewswire/ — Genomic Health, Inc. (Nasdaq: GHDX) today announced positive preliminary results from a second large, independent clinical validation study of Oncotype DX® in patients with a pre-invasive form of breast cancer, also known as DCIS (ductal carcinoma in situ). The study, conducted by the Ontario DCIS Study Group in Canada, met its primary endpoint by demonstrating that the Oncotype DX DCIS Score((TM)) predicts the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast.

Representing the largest genomic study in DCIS to date, these results confirm and extend the conclusions of the previously published validation study performed by the ECOG-ACRIN Cancer Research Group. Additionally, for the first time, the Oncotype DX DCIS Score predicted the risk of local recurrence in a group of patients treated with radiation therapy in clinical practice. Genomic Health and the Ontario DCIS Study Group are submitting the results from this study for presentation at the 2014 San Antonio Breast Cancer Symposium in December.

“It is widely recognized that a large proportion of women with DCIS are treated with a limited ability to quantify risk associated with the patient’s underlying tumor biology,” said Eileen Rakovitch, M.D., radiation oncologist and principal investigator, Sunnybrook Health Sciences Centre, Canada. “Our landmark study, analyzing an unprecedented collection of DCIS tissue samples representative of a contemporary patient population, confirms that the Oncotype DX test can help individualize treatment decisions for this pre-invasive type of breast cancer.”

Genomic Health researchers collaborated with the Ontario DCIS Study Group to examine a population-based cohort of more than 1,200 DCIS patient tumor samples collected from patients diagnosed with DCIS between 1994 and 2003, including both patients treated with surgery alone and patients treated with surgery plus radiation.

“This international collaboration between scientists and clinicians in the U.S. and Canada has demonstrated, once again, the important role of integrating genomic information from Oncotype DX to guide more informed treatment decisions,” said Steven Shak, M.D., executive vice president of research and development, Genomic Health.

DCIS — an early, non-invasive form of breast cancer, considered stage zero, in which the tumor cells are confined within the milk ducts in the breast — affects one out of every five women diagnosed with breast cancer in the U.S. Most women with DCIS who receive breast-conserving surgery without standard radiotherapy will not develop a local recurrence. However, an estimated 80 percent of these women currently receive additional treatments that may not be necessary, while other women may not appropriately receive more aggressive treatment resulting in the development of cancers that might have been preventable with treatment.

To help a woman and her doctor make a more informed decision about her DCIS treatment, Genomic Health developed the Oncotype DX DCIS Score to provide more precise information about her individual risk of a recurrence of either DCIS or invasive breast cancer by looking at 12 genes within a tumor sample to reveal the aggressiveness of the disease. A clinical decision impact study recently presented at ASCO® demonstrated that the Oncotype DX DCIS Score results changed treatment recommendations for one out of three patients with DCIS, highlighting the need for optimizing treatment of this non-invasive form of breast disease.

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 March 31, 2014, more than 19,000 physicians in over 70 countries had ordered more than 440,000 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 benefits of the company’s tests for patients with DCIS; limitations of current treatment options; the company’s expectations regarding reporting study results; the attributes and focus of the company’s product pipeline; the applicability of clinical study results to actual outcomes; the ability of any potential tests the company may develop to optimize cancer treatment; and the ability of the company to develop and commercialize additional tests in the future. 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 risks and uncertainties associated with the regulation of the company’s tests; the full results of the clinical study; the applicability of clinical study results to actual outcomes; our ability to develop and commercialize new tests and expand into new markets domestically and internationally; 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 of competition; unanticipated costs or delays in research and development efforts; the company’s ability to obtain capital when needed 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 March 31, 2014. 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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