REDWOOD CITY, Calif., Jan. 28 /PRNewswire-FirstCall/ -- Genomic Health, Inc. today announced the results of studies that have identified genes that could help predict the likelihood of recurrence and chemotherapy benefit for early-stage (stage II and III) colon cancer. The company is conducting detailed analyses of these studies to select a final gene set for a clinical assay to quantify the risk of recurrence and likelihood of chemotherapy benefit, which will be evaluated in an independent validation study.
Results of the studies were presented January 26, 2008 at ASCO GI, the American Society of Clinical Oncology's Gastrointestinal Cancers Symposium, in Orlando, Florida.
"These results allow us to conclude that quantitative gene expression using methods developed by Genomic Health can identify genes that may predict the likelihood of colon cancer recurrence and chemotherapy benefit," said Steven Shak, M.D., chief medical officer of Genomic Health. "This marks an important step in our effort to develop a test to personalize treatment decisions for early-stage colon cancer patients using the same rigorous clinical development and validation process as we did with Oncotype DX for breast cancer."
Both study reports used Genomic Health's quantitative RT-PCR to analyze RNA expression for 375 cancer-related and reference genes from colon tumors of patients who were treated with surgery alone or with surgery and adjuvant 5-fluorouracil/leucovorin (5-FU/LV) chemotherapy.
The first report evaluated colon cancers from patients treated with surgery alone, including 270 patients from the National Surgical Adjuvant Breast & Bowel Project (NSABP) C-01/C-02 study and 765 patients who were treated at the Cleveland Clinic. Researchers identified 65 genes significantly associated with colon cancer recurrence across both patient populations. The range of individual gene expression was associated with an up to 11-fold difference in risk of disease recurrence.
The second report analyzed colon cancers from an additional 508 patients who were treated with surgery plus 5-FU/LV chemotherapy in NSABP study C-06. Of the 375 genes, the researchers identified 56 that were significantly associated with disease prognosis for stage II and III colon cancer in this study as well as in patients treated with surgery alone in NSABP C-01/C-02 and at the Cleveland Clinic. Furthermore, the collaborators used 15 of the 56 genes as a preliminary model to stratify patients into recurrence risk categories.
Genomic Health has completed four independent studies involving 1,851 colon cancer patients to evaluate a total of 761 genes. These data will support the selection of the final gene set, which will undergo clinical validation of its utility in guiding treatment decisions with adjuvant 5-FU/LV chemotherapy.
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 ability of the identified genes to predict the likelihood of recurrence and chemotherapy benefit in early-stage colon cancer patients, the belief that the genes it has evaluated will support selection of a final gene set, the timing and outcome of any validation studies and the ability of the Company to develop a test for early-stage colon cancer. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, but are not limited to: risks associated with the development and validation of new products; the applicability of clinical results to actual outcomes; 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; the results of clinical studies 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 September 30, 2007. 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.
CONTACT: Investors, Brad Cole, +1-650-569-2281,
investors@genomichealth.com, or Media, Emily Faucette, +1-650-569-2824,
media@genomichealth.com, both of Genomic Health
Web site: http://www.genomichealth.com/
