REDWOOD CITY, Calif., July 14, 2015 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced that Breast Cancer Research and Treatment published results from a second large clinical validation study of Oncotype DX® in patients with stage 0 breast cancer, also known as DCIS (ductal carcinoma in situ). The population-based study, conducted by the Ontario DCIS Study Group, reconfirmed that the Oncotype DX DCIS Score™ is a strong predictor of local recurrence (p<0.001), which could be either invasive breast cancer or DCIS.
"Our study analyzed the impact of the DCIS Score as an independent predictor of local recurrence in a population cohort of individuals with pure DCIS treated by breast-conserving surgery with clear margins," said lead investigator Eileen Rakovitch, M.D., FRCP(C), M.Sc., Sunnybrook Research Institute, Institute for Clinical Evaluative Sciences, Toronto.
Based on a population-based cohort of 828 DCIS tumor samples collected between 1994 and 2003 in Canada, the primary analysis focused on 571 patients who were treated with breast-conserving surgery alone and had clear margins. The newly published results of the study identified that the majority of studied DCIS patients (62 percent) were low risk based on the tumor biology revealed by the Oncotype DX DCIS Score. The remaining cases had an intermediate-risk or high-risk score, and these patients experienced a higher risk of local recurrence. These findings are consistent with those of the original ECOG-ACRIN Cancer Research Group clinical validation study, which demonstrated that the DCIS Score quantified the 10-year risk of local recurrence beyond clinical factors such as tumor size and grade.
"This new publication, combined with a recently published study showing that Oncotype DX changes treatment decisions in nearly 30 percent of DCIS patients, supports broader adoption of our test and provides further confidence to physicians and their patients as they include the test in treatment decision-making," said Frederick Baehner, M.D., vice president, Pathology, Genomic Health.
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 80 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.
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 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, YouTube and LinkedIn.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the benefits of the test to physicians, patients and payors. 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 ability of test results to change treatment decisions; 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; 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; 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 year ended March 31, 2015. 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.