Oncotype DX® DCIS Score™ Represents Breakthrough in Personalizing Treatment of Pre-Invasive Breast Cancer

SAN ANTONIO, Dec. 12, 2014 /PRNewswire/ -- Genomic Health, Inc. GHDX today announced positive results from the second large clinical validation study of Oncotype DX^® in patients with a pre-invasive form of breast cancer known as DCIS (ductal carcinoma in situ).  The study, conducted by the Ontario DCIS Study Group of Sunnybrook Health Sciences Centre in Canada, reconfirmed that the Oncotype DX DCIS Score^™ is a strong predictor of local recurrence, which could be either invasive breast cancer or DCIS (p<0.001). 

"When a woman is diagnosed with DCIS, my goal as a physician is to accurately assess her individual risk for cancer returning so we can define and personalize an appropriate treatment plan with greater confidence," said Michael Alvarado, M.D., breast cancer surgeon, the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center. "This landmark study analyzed an unprecedented collection of tissue samples and reconfirmed Oncotype DX as an objective biomarker that provides independent information beyond what has been available to physicians before, which can be seen as the biggest advancement in the management of DCIS in more than a decade." 

This largest genomic study in DCIS to date examined a broad, population-based cohort of more than 1,200 DCIS patient tumor samples collected from patients diagnosed with DCIS between 1994 and 2003 in Ontario, Canada.  The primary analysis, presented at the 2014 San Antonio Breast Cancer Symposium (SABCS), included 571 patients who were treated with breast-conserving surgery where the tumor was completely removed.  The results, which are consistent with those of the original ECOG-ACRIN Cancer Research group clinical validation study, demonstrated that the DCIS Score quantified the 10year risk of local recurrence beyond clinical factors such as tumor size and grade.  This analysis clearly identified that the majority (62 percent) of studied DCIS patients were low risk based on the tumor biology revealed by the Oncotype DX test. 

"Sunnybrook's study marks a new era in personalized treatment for tens of thousands of women diagnosed with DCIS each year," said Frederick Baehner, M.D., vice president, Pathology, Genomic Health and assistant professor at the University of California, San Francisco.  "We believe that the strength and breadth of these positive results will expand adoption of the Oncotype DX DCIS Score and provide further confidence to physicians and their patients as they include the test in making their treatment decisions."

Separately, at SABCS Genomic Health presented positive results from its first liquid biopsy study demonstrating the company's ability to detect breast cancer in blood.  Additional presentations included the first prospective outcomes data for the Oncotype DX breast cancer test from one of Europe's largest contemporary adjuvant breast cancer trials that was designed to evaluate anthracyline-free adjuvant chemotherapy and used the test to stratify patients according to their risk of recurrence. 

About Genomic Health
Genomic Health, Inc. 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 diagnosis to treatment selection and monitoring.  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, Facebook and LinkedIn.

About Oncotype DX®
The Oncotype DX® portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company's flagship 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.  Additionally, the test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. 

With half a million patients tested in more than 70 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment.  To learn more about Oncotype DX breast cancer tests, visit: www.OncotypeDX.com or 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 company's belief that the study marks a new era in personalized treatment for women diagnosed with DCIS; the company's belief that the study results will expand adoption of its test; the attributes and benefits of the company's tests to physicians and patients; the attributes and focus of the company's product pipeline; the company's belief that it is applying its infrastructure and expertise to lead the translation of genomic data into clinically actionable results; the applicability of clinical study results to actual outcomes; 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 risks and uncertainties associated with the regulation of the company's tests; the results of clinical studies; 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 September 30, 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.