New findings reinforce value of Oncotype DX in node-positive breast cancer patients; separate presentation provides background on development of DCIS Score
SAN FRANCISCO, Sept. 13, 2012 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced positive results of a large study that demonstrates the Oncotype DX® Recurrence Score® result to be a robust predictor of distant recurrence, disease-free survival, and overall survival in women with node-positive breast cancer who were treated with anthracycline-containing chemotherapy regimens. Highlighted in the official meeting presscast, these study results will be presented during the 2012 Breast Cancer Symposium, September 13-15, in San Francisco.
"Personalized medicine requires an accurate assessment of the patient's individual tumor biology in order to help determine the most appropriate treatment plan," said Terry Mamounas, M.D., medical director, Aultman Cancer Center, and member of the National Surgical Adjuvant Breast and Bowel Project (NSABP) board. "These new data show that for lymph node-positive breast cancer patients, Oncotype DX can help identify those who will have excellent outcomes with adjuvant chemo-endocrine therapy, versus those who are at greater risk of recurrence and may need additional treatment."
This study analyzes tumor samples from 1,065 hormone-positive, node-positive breast cancer patients who were treated with anthracycline-containing chemotherapy as part of the NSABP B-28 trial. This evaluation of distant recurrence, disease-free survival, and overall survival, is part of a study that also includes analysis of B-28 data on local regional recurrence, to be reported at a later date.
"These results add to a large body of evidence, now totaling more than 2,000 patients, demonstrating that the Recurrence Score provides independent distant recurrence risk information that provides value beyond clinical and pathologic factors in node-positive disease," said Steven Shak, M.D., chief medical officer at Genomic Health. "Across multiple studies, we observe consistent support for the use of Oncotype DX as a useful tool to guide treatment decisions for early-stage breast cancer patients, including those with node-positive disease."
The oral presentation of the study, titled "Prognostic impact of the 21-gene Recurrence Score on disease-free and overall survival of node-positive, ER-positive breast cancer patients treated with adjuvant chemotherapy: Results from NSABP B-28" (Abstract #1), will take place on Thursday, September 13, 2012 at 9:30 a.m. Pacific Daylight Time.
Additionally, Genomic Health will present a poster on the development of the Oncotype DX DCIS Score™ that provides additional background information on the scaling and risk cut-off points based on a study of a broad population of 100 DCIS (ductal carcinoma in situ of the breast) patients. In this analysis, the DCIS Score was widely distributed over all clinical and pathologic characteristics assessed. The poster titled "The development of the DCIS score: Scaling and normalization in the Marin Medical Laboratories cohort" (Abstract #190), will be presented on Thursday, September 13, 2012, Poster Session A.
Six leading medical specialty societies co-sponsor the three-day, multidisciplinary symposium, including the American Society of Breast Disease, the American Society of Breast Surgeons, the American Society of Clinical Oncology, the American Society for Radiation Oncology, the National Consortium of Breast Centers and the Society of Surgical Oncology.
About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is a global health company that provides actionable genomic information to personalize genomic health decisions. The company'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. As of June 30, 2012, more than 10,000 physicians in over 65 countries had ordered more than 295,000 Oncotype DX tests. Genomic Health has a robust pipeline focused on developing tests to optimize the treatment of prostate and renal cell cancers, as well as additional treatment decisions in breast and colon cancers. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com. To learn more about Oncotype DX tests, visit: www.OncotypeDX.com and 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 ability of the test to optimize cancer treatment in patients with node positive disease; the ability of the recurrence score to impact treatment decisions in a clinical setting; the applicability of study results to clinical practice; the timing and results of future studies; the focus of the company's product pipeline, the ability of the company to develop additional tests in the future , 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 applicability of clinical study results to actual outcomes; the risks and uncertainties associated with possible additional regulation of our tests both in the United States and abroad; the risks associated with the commercialization of current and future products; the risks associated with competition; the risks and potential delays associated with such studies; 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 quarter ended June 30, 2012. 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.