- Seventh Study Showing Oncotype DX Frequently Changes Treatment
Recommendations in Clinical Practice -
REDWOOD CITY, Calif., Nov. 10 /PRNewswire-FirstCall/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced the publication of results from a study indicating that Oncotype DX(R) Recurrence Score(R) results impact the way physicians treat early-stage breast cancer. The study, published in the October issue of the American Journal of Surgery, showed that treatment changed as a result of Oncotype DX in 44 percent of patients with node- negative estrogen receptor-positive breast cancer.
"The results of this study confirm that the decision to administer chemotherapy in node-negative estrogen receptor-positive breast cancer patients should no longer be based solely on traditional clinical and pathologic criteria, but also by integrating the Oncotype DX Recurrence Score into the decision," Paul Tartter, M.D., St. Luke's-Roosevelt Hospital Center, New York.
The study investigators completed a retrospective chart review of 85 consecutive patients with node-negative, estrogen receptor-positive breast cancer who had used the Oncotype DX breast cancer assay. Patients were divided into three risk categories based on the Recurrence Score result. Researchers compared treatment recommendations made utilizing the Recurrence Score result to recommendations made based on the 2007 National Comprehensive Cancer Network (NCCN) guidelines before Oncotype DX was incorporated into those guidelines.
Results showed that the Oncotype DX assay result influenced recommendations concerning chemotherapy in 37 patients (44 percent). Thirty- three patients who would have received a recommendation for chemotherapy based on the 2007 NCCN guidelines received a recommendation for hormone therapy alone based on their Oncotype DX Recurrence Score of less than 18. Conversely, and notably, four patients who would have received a recommendation against chemotherapy based on the 2007 NCCN guidelines were placed in the high-risk group based on their Recurrence Score of greater than 31 and received a recommendation for chemotherapy.
"As more physicians incorporate Oncotype DX into clinical practice, we gain important insight into its impact on the treatment decision process for physicians and patients," said Steven Shak, M.D., chief medical officer of Genomic Health. "There are now seven studies, conducted by independent physicians who use the test in clinical practice, demonstrating that Oncotype DX optimizes the use of chemotherapy to ensure those women who need chemotherapy get it, while sparing those who are not likely to benefit from its side effects and high costs."
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 eleven clinical 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 75,000 tests, and both Medicare and private health plans covering approximately 90 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. (Nasdaq: GHDX) 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 impact of Oncotype DX on treatment decisions and the insights that may be gained from use of the company's test. 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 or maintain sufficient levels of reimbursement for our test; 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.
|SOURCE Genomic Health, Inc.|
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