September 3, 2008
Genomic Health Announces Publication of a Study Comparing Oncotype DX(R) and Adjuvant! Online in Node-Negative and Node-Positive Hormone Receptor-Positive Breast Cancer Patients
REDWOOD CITY, Calif., Sept. 3 /PRNewswire-FirstCall/ -- Genomic Health, Inc. today announced the publication of positive results from a study indicating that the Oncotype DX(R) Recurrence Score(R) provides additional prognostic information beyond Adjuvant! Online (AO) for breast cancer patients with negative nodes or up to three positive nodes. The study, published in the September 1st issue of the Journal of Clinical Oncology, showed that the Recurrence Score result was a highly significant predictor of recurrence in both node-negative disease (p=0.0007) and node-positive disease (p=0.0004).
Oncotype DX measures the expression of 21 genes of an individual tumor to generate a Recurrence Score result that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for a large portion of early-stage breast cancer patients. Adjuvant! Online serves as an online tool that evaluates clinical variables to help physicians and patients assess the risks and benefit of getting additional therapy after surgery."This study shows the significant added benefit of genomic analysis with Oncotype DX, when used in conjunction with the traditional clinical variables as measured by Adjuvant Online," said Steven Shak, M.D., chief medical officer of Genomic Health. "These results, combined with ASCO and NCCN treatment guidelines recommending the use of Oncotype DX, clearly demonstrate that the test provides critical information for breast cancer treatment planning that is not apparent by examination of clinical variables either alone or when combined using Adjuvant! Online."
The study assessed 465 patients from a previous Eastern Cooperative Oncology Group (ECOG) study with hormone receptor-positive breast cancer, who had zero to three positive or negative axillary lymph nodes and received contemporary chemohormonal therapy. Researchers compared the prognostic utility of the Oncotype DX Recurrence Score to clinicopathologic features individually and when integrated by an algorithm similar to Adjuvant Online that was adjusted to five-year outcomes. The results demonstrated that Oncotype DX provides information on distant and local/regional recurrence risk independent of and beyond that provided by either nodal status or Adjuvant! Online, suggesting the Recurrence Score offers complementary treatment insight in patients with up to three positive nodes.
"Both the Oncotype DX Recurrence Score and Adjuvant! Online are of considerable value in providing breast cancer patients and their physicians with vital information on the probability of disease relapse for the purpose of selecting individual treatment as well as clinical trial participation," said Peter Ravdin, M.D., Ph.D., the M.D. Anderson Cancer Center physician who developed the Adjuvant Online tool and a co-author of the study. "By combining these two highly effective measurement tools, we can more reliably predict patient benefit associated with specific therapies, ultimately making more individualized treatment recommendations."
About Oncotype DX(R)
Oncotype DX is the first and only multi-gene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. Additionally, the test report provides quantitative scores for certain individual genes. Oncotype DX has been extensively evaluated in multiple independent studies involving nearly 4,000 breast cancer patients, including a large validation study published in The New England Journal of Medicine and a chemotherapy benefit study published in the Journal of Clinical Oncology. To date, 7,500 physicians have ordered more than 65,000 tests, and health plans covering over 80 percent of U.S. insured lives provide reimbursement for Oncotype DX through contracts, agreements and policy decisions. Both the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network recommend the use of Oncotype DX for patients with node- negative breast cancer that is estrogen-receptor positive and/or progesterone- receptor positive. For more information about Oncotype DX, please visit http://www.oncotypedx.com/.
About Genomic Health
Genomic Health, Inc. is a life science company focused on the development and commercialization of genomic-based clinical laboratory services for cancer that allow physicians and patients to make individualized treatment decisions. In 2004, Genomic Health launched its first test, Oncotype DX(R), which has been shown to predict the likelihood of breast cancer recurrence and the likelihood of chemotherapy benefit in a large portion of early-stage breast cancer patients. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit http://www.genomichealth.com/.
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 results of this study indicate that Oncotype DX may be used to tailor more specific chemotherapy treatment regimens in breast cancer patients with up to three positive lymph nodes than that which may be apparent by examining clinical variables alone or when combined using Adjuvant! Online, the belief that the use of Oncotype DX provides additional information on recurrence risk independent of and beyond that provided by nodal status or Adjuvant! Online in certain patient populations, and the belief that the use of Oncotype DX with Adjuvant! Online may allow physicians to more reliably predict patient benefit associated with specific therapies. These risks and uncertainties include, but are not limited to: the results of additional clinical studies; the applicability of clinical study results to actual outcomes; the risk that we may not obtain sufficient levels of reimbursement for any future tests we may develop; our ability to develop and commercialize new products; the risks and uncertainties associated with the regulation of our tests by FDA; our ability to obtain capital when needed; our history of operating losses and the other risks set forth in our filings with the Securities and Exchange Commission, including the risks set forth in our Quarterly Report on Form 10-Q for the three-month period ended June 30, 2008. 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 and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.
Genomic Health, Inc.
Web site: http://www.genomichealth.com/http://www.oncotypedx.com/