Genomic Health Announces Publication of a Study Demonstrating the Oncotype DX(R) Breast Cancer Assay Influences Chemotherapy Treatment Recommendation in 44 Percent of Patients Evaluated
"The results of this study confirm that the decision to administerchemotherapy in node-negative estrogen receptor-positive breast cancerpatients should no longer be based solely on traditional clinical andpathologic criteria, but also by integrating the Oncotype DX Recurrence Scoreinto the decision," Paul Tartter, M.D., St. Luke's-Roosevelt Hospital Center,New York.
The study investigators completed a retrospective chart review of 85consecutive patients with node-negative, estrogen receptor-positive breastcancer who had used the Oncotype DX breast cancer assay. Patients were dividedinto three risk categories based on the Recurrence Score result. Researcherscompared treatment recommendations made utilizing the Recurrence Score resultto recommendations made based on the 2007 National Comprehensive CancerNetwork (NCCN) guidelines before Oncotype DX was incorporated into thoseguidelines.
Results showed that the Oncotype DX assay result influencedrecommendations concerning chemotherapy in 37 patients (44 percent). Thirty-three patients who would have received a recommendation for chemotherapy basedon the 2007 NCCN guidelines received a recommendation for hormone therapyalone based on their Oncotype DX Recurrence Score of less than 18.Conversely, and notably, four patients who would have received arecommendation against chemotherapy based on the 2007 NCCN guidelines wereplaced in the high-risk group based on their Recurrence Score of greater than31 and received a recommendation for chemotherapy.
"As more physicians incorporate Oncotype DX into clinical practice, wegain important insight into its impact on the treatment decision process forphysicians and patients," said Steven Shak, M.D., chief medical officer ofGenomic Health. "There are now seven studies, conducted by independentphysicians who use the test in clinical practice, demonstrating that OncotypeDX optimizes the use of chemotherapy to ensure those women who needchemotherapy get it, while sparing those who are not likely to benefit fromits side effects and high costs."
About Oncotype DX(R)
Oncotype DX is the first and only multi-gene expression test commerciallyavailable that has clinical evidence validating its ability to predict thelikelihood of chemotherapy benefit as well as recurrence in early-stage breastcancer. Additionally, the test report provides quantitative scores forcertain individual genes. Oncotype DX has been extensively evaluated in elevenclinical studies involving nearly 4,000 breast cancer patients, including alarge validation study published in The New England Journal of Medicine and achemotherapy benefit study published in the Journal of Clinical Oncology. Todate, 7,500 physicians have ordered more than 75,000 tests, and both Medicareand private health plans covering approximately 90 percent of U.S. insuredlives provide reimbursement for Oncotype DX through contracts, agreements andpolicy decisions. Both the American Society of Clinical Oncology (ASCO) andthe National Comprehensive Cancer Network recommend the use of Oncotype DX forpatients with node- negative breast cancer that is estrogen-receptor positiveand/or progesterone- receptor positive. For more information about OncotypeDX, please visit http://www.oncotypedx.com.
About Genomic Health
Genomic Health, Inc. (Nasdaq: GHDX) is a life science company focused onthe development and commercialization of genomic-based clinical laboratoryservices for cancer that allow physicians and patients to make individualizedtreatment decisions. In 2004, Genomic Health launched its first test,Oncotype DX(R), which has been shown to predict the likelihood of breastcancer recurrence and the likelihood of chemotherapy benefit in a largeportion of early-stage breast cancer patients. The company was founded in2000 and is located in Redwood City, California. For more information, pleasevisit http://www.genomichealth.com.
This press release contains forward-looking statements within the meaningof the Private Securities Litigation Reform Act of 1995, including statementsrelating to the impact of Oncotype DX on treatment decisions and the insightsthat may be gained from use of the company's test. These risks anduncertainties include, but are not limited to: the results of additionalclinical studies; the applicability of clinical study results to actualoutcomes; the risk that we may not obtain or maintain sufficient levels ofreimbursement for our test; the risks and uncertainties associated with theregulation of our tests by FDA; our ability to obtain capital when needed; ourhistory of operating losses and the other risks set forth in our filings withthe Securities and Exchange Commission, including the risks set forth in ourQuarterly 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. GenomicHealth disclaims any obligation to update these forward- looking statements
NOTE: The Genomic Health logo, Oncotype, Oncotype DX and Recurrence Scoreare trademarks or registered trademarks of Genomic Health, Inc. All othertrademarks and service marks are the property of their respective owners.
SOURCE Genomic Health, Inc.
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