SAN ANTONIO, Dec. 15 /PRNewswire-FirstCall/ -- Genomic Health, Inc. today announced positive results from a study showing that the Oncotype DX Recurrence Score(TM) provides additional prognostic information in patients with early-stage breast cancer beyond that derived from Adjuvant Online, an online tool that evaluates clinical variables to help physicians and patients assess the risks and benefits of getting additional therapy after surgery. Oncotype DX(R) measures the expression of 21 genes of an individual tumor to generate a Recurrence Score result that quantifies the likelihood of recurrence and the magnitude of chemotherapy benefit for a large portion of early-stage breast cancer patients. The results of the research were presented orally today at the 30th Annual San Antonio Breast Cancer Symposium.
"This study shows the significant added benefit of genomic analysis with Oncotype DX, when used in conjunction with the traditional clinical variables as measured by Adjuvant Online," said Steven Shak, M.D., chief medical officer of Genomic Health. "These results, combined with updated ASCO treatment guidelines now recommending Oncotype DX, clearly demonstrate that Oncotype DX provides critical information for breast cancer treatment planning that is not apparent by examination of clinical variables alone."
The comparison study assessed 465 patients with hormone receptor-positive breast cancer from a previous Eastern Cooperative Oncology Group (ECOG) study, computing both the Adjuvant Online risk estimate and Oncotype DX Recurrence Score result for each patient. The study found that the Recurrence Score result was a highly significant predictor of recurrence in both node-negative disease (p=0.0007) and node-positive disease (p=0.0004). In addition, a low Recurrence Score result predicted a low likelihood of recurrence regardless of nodal status.
"In examining the relationship between the Oncotype DX Recurrence Score and Adjuvant Online, we found that both tools have value in providing crucial information on the likelihood of breast cancer recurrence," said Peter Ravdin, M.D., Ph.D., the M.D. Anderson Cancer Center physician who developed the Adjuvant Online tool and a co-author of the study. "Specifically, the addition of Oncotype DX Recurrence Score results yielded supplementary insight on outcomes for breast cancer patients. Used together, we have the opportunity to more effectively guide personal treatment decisions based on a woman's individual breast cancer."
About Oncotype DX(R)
Oncotype DX is the first diagnostic multi-gene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of breast cancer recurrence, the likelihood of breast cancer survival and the likelihood of chemotherapy benefit. Oncotype DX has been extensively evaluated in multiple independent studies involving more than 3,300 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, nearly 7,000 physicians have ordered more than 40,000 tests, and health plans covering over 50 percent of U.S. insured lives provide reimbursement for Oncotype DX through contracts, agreements and policy decisions. The American Society of Clinical Oncologists (ASCO) recommends 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. 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 additional benefit in treatment planning that is possible by the use of Oncotype DX and the opportunity to more effectively guide such treatment decisions by using Oncotype DX in conjunction with an analysis of clinical variables. 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: the applicability of clinical results to actual outcomes; the ability of our test to continue to impact treatment decisions; our ability to increase usage of our tests; the risk that we may not obtain or maintain sufficient levels of reimbursement for our existing tests and any future tests we may develop; the risks and uncertainties associated with the regulation of our test 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: Genomic Health, 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.
