REDWOOD CITY, Calif., Jan. 12 /PRNewswire-FirstCall/ -- Genomic Health, Inc. (Nasdaq: GHDX) announced today that it has initiated an independent clinical validation study for its 18-gene Oncotype DX(R) colon cancer assay. Utilizing more than 1,200 patient samples from the landmark QUASAR trial, the validation study will use prospectively defined endpoints to assess the clinical utility of the Oncotype DX colon cancer assay to predict likelihood of recurrence for stage II colon cancer patients treated with surgery alone and the magnitude of treatment benefit with chemotherapy following surgery. Results from the study are expected to be reported in the second half of 2009.
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Stage II colon cancer (also known as Dukes' Stage B) affects an approximately 30-40,000 people each year in the United States and the current treatment paradigm is unclear. About a third of patients receive adjuvant chemotherapy, usually 5-fluorouracil/leucovorin (5FU/LV) or combinations that include 5FU/LV; however, research indicates that only 2-4 percent benefit from this treatment, which has significant associated toxicity. While there are existing clinical markers traditionally associated with higher-risk in colon cancer patients, there is no clinically validated genomic test available that predicts the likelihood of recurrence or magnitude of chemotherapy benefit for individual patients.
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"There is a critical need for more targeted approaches in treating the tens of thousands of patients with stage II colon cancer and the initiation of this study brings us one step closer to delivering a tool that may do that," said Steven Shak, M.D., chief medical officer, Genomic Health. "Over the past two years we have partnered with the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the Cleveland Clinic Foundation to evaluate more than 1,800 patients and 760 candidate genes to select the final 18-gene set for the Oncotype DX colon cancer assay. In developing this assay we have applied the same rigor and technology used to validate the Oncotype DX breast cancer assay, a test that has helped guide treatment decisions for more than 75,000 women with early-stage disease."
To date, Genomic Health has completed four development studies to identify and select the 18 genes for the Oncotype DX colon cancer assay. The validation study is utilizing samples from QUASAR, the largest study of its kind. An international, multi-center trial, QUASAR examined the benefit associated with adjuvant 5FU/LV for patients with stage II colon cancer. The majority of samples for this analysis of the Oncotype DX colon cancer assay are from the United Kingdom.
Unlike the Oncotype DX breast cancer assay that captures both recurrence and treatment benefit in one Recurrence Score, the prognostic and predictive genes in the colon cancer assay do not overlap. As such, this colon cancer assay was designed to generate both a prognostic Recurrence Score and predictive Treatment Score. Researchers will evaluate the association of the Recurrence Score with recurrence in stage II colon cancer patients treated with surgery alone. They will also evaluate the association of the Treatment Score with the magnitude of chemotherapy benefit in patients treated with adjuvant 5FU/LV chemotherapy.
"In the absence of reliable prognostic and predictive tools to select stage II colon cancer patients for adjuvant chemotherapy, over- and under-treatment present significant challenges," said Alan Venook, M.D., Professor of Clinical Medicine, Gastrointestinal Oncology Research Program at UCSF Medical Center. "With increasing numbers of people being diagnosed with early-stage disease, a well-validated predictive or prognostic test could be very useful in helping us optimize treatment plans for these patients, potentially sparing them from chemotherapy they do not need."
As previously announced, Genomic Health will present at the 27th Annual JPMorgan Healthcare Conference in San Francisco on Wednesday, January 14 at 10:30 a.m. Pacific Time. To access the live and subsequently archived webcast of the presentation, visit the Investor Relations section of Genomic Health's Web site at http://investor.genomichealth.com. Please connect to the Web site at least 15 minutes prior to the beginning of the presentation to allow for any necessary software downloads. An archived replay will be available for three months beginning 24 hours after the live presentation.
About Oncotype DX(R) breast cancer assay
The Oncotype DX breast cancer assay 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. The Oncotype DX breast cancer assay has been extensively evaluated in eleven clinical studies involving more than 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 or 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 company's expectation regarding the timing of reporting results of the validation study, the company's belief that the initiation of the clinical validation study brings it closer to delivering a tool that may lead to more targeted approaches to treating stage II colon cancer, and the potential utility, attributes or impact of a predictive or prognostic test for stage II colon cancer. These risks and uncertainties include, but are not limited to: the results of the clinical validation study; delays or difficulties in completion of the clinical validation study; the applicability of clinical study results to actual outcomes; the risk that the company may not obtain sufficient levels of reimbursement for any future tests it may develop; the company's ability to develop and commercialize new products; the risks and uncertainties associated with the regulation of the company's tests by FDA; the company's ability to obtain capital when needed; the company's history of operating losses and the other risks set forth in its filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the three-month period ended September 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.
