REDWOOD CITY, Calif., May 31 /PRNewswire-FirstCall/ -- Genomic Health, Inc. today announced that the journal Breast Cancer Research published results from a large clinical study conducted by Kaiser Permanente confirming that Oncotype DX, the company's breast cancer test service, also helps predict the likelihood of breast cancer survival in a community setting that represents approximately one percent of the U.S. population. This is the third large study supporting the clinical utility of Oncotype DX to be published in a peer-reviewed journal, and follows studies reported in the Journal of Clinical Oncology last week and The New England Journal of Medicine in December 2004.
In this group of women with lymph node-negative breast cancer, researchers found a statistically significant correlation between the Oncotype DX Recurrence Score and breast cancer survival. Specifically, risk of death from breast cancer at 10 years was 2.8 percent for women with a Recurrence Score less than 18, 10.7 percent for women with a Recurrence Score between 18 and 31, and 15.5 percent for women with a Recurrence Score greater than or equal to 31.
"This landmark, first-of-its-kind epidemiological study in breast cancer demonstrates a statistically significant association between the Oncotype DX Recurrence Score and survival, independent of traditional measures such as tumor size and grade," said Laurel Habel, Ph.D., an investigator with Kaiser Permanente's Division of Research and the lead author of the study.
About the Study
Using Kaiser Permanente's extensive Northern California patient database, which represents approximately one percent of the U.S. population, Kaiser and Genomic Health designed a case-controlled study with prospectively defined endpoints that evaluated records of nearly 5,000 node-negative, non-chemotherapy-treated breast cancer patients diagnosed between 1985 and 1994 at 14 Northern California Kaiser Permanente hospitals. Researchers compared 220 patients who died with 570 matched control patients. As seen in current clinical practice, more than 30 percent of patients had small tumors (1 cm or less).
The study used Genomic Health's Oncotype DX test service to analyze each patient's archived tumor tissue by measuring the expression profile of a panel of 21 genes involved in breast cancer, including those related to the estrogen receptor, the HER2 gene and proliferation, as well as several other pathways. Based on results of the test, a Recurrence Score from 0-100 was assigned.
"These results are consistent with those from previous large clinical trials conducted with the National Surgical Adjuvant Breast and Bowel Project (NSABP)," said Steven Shak, M.D., chief medical officer of Genomic Health, Inc. "Taken with the two previous peer-reviewed published studies, this study provides further support for increased adoption, use and reimbursement of Oncotype DX to help physicians and breast cancer patients in making optimal treatment decisions."
About Oncotype DX
Oncotype DX represents the first diagnostic multi-gene expression service that has clinical evidence validating its ability to predict the likelihood of breast cancer recurrence, the likelihood of patient survival within 10 years of diagnosis and the likelihood of chemotherapy benefit. It has been extensively evaluated in multiple independent studies involving more than 2,600 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. For more information about Oncotype DX, please visit 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 service, Oncotype DX(TM), which has been shown to predict the likelihood of breast cancer recurrence and chemotherapy benefit in early-stage breast cancer patients. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit www.genomichealth.com.
Forward Looking Statements
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 the publication of the study on adoption, use and reimbursement of Oncotype DX and the applicability of clinical study results to actual outcomes. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, including the risks set forth in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2006. These forward-looking statements speak only as of the date hereof. We disclaim 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.CONTACT: Emily Faucette of WeissComm Partners, +1-415-946-1066, forGenomic Health; or Brad Cole of Genomic Health, +1-650-569-2281
Web site: http://www.genomichealth.com//
