CHICAGO, June 2 /PRNewswire-FirstCall/ -- Genomic Health, Inc. today announced results of an independent prospective multi-center study indicating that the Oncotype DX Recurrence Score changes treatment decisions and increases confidence for a high proportion of patients with early-stage node-negative, estrogen receptor-positive breast cancer. Results from this study were presented today at the 43rd annual meeting of the American Society of Clinical Oncology (Abstract #577).
In a study of 89 patients treated by 17 medical oncologists from three academic and one community practice, knowledge of a patient's Recurrence Score changed treatment recommendations and decisions for 31.5 percent of oncologists and 27 percent of patients, respectively. The most common change was to switch from a plan for chemotherapy plus hormonal therapy before receiving Recurrence Score results to hormonal therapy alone after a low Recurrence Score result was obtained. Less commonly, the treatment decision switched from a plan for hormonal therapy alone to chemotherapy plus hormonal therapy after a high Recurrence Score result was obtained.
"Our study demonstrates that the Recurrence Score influenced treatment practice at both the academic and community hospital level, while giving patients and physicians greater confidence in their decisions," said Kathy S. Albain, M.D., Professor, Division of Hematology/Oncology, Department of Medicine, Loyola University Chicago Stritch School of Medicine, Director, Breast Clinical Research Program, Cardinal Bernardin Cancer Center, Loyola University Health System, Maywood, Ill., and senior author of the study. "We believe these results confirm the ability of Oncotype DX to help individualize the treatment of breast cancer based on the unique characteristics of a woman's own tumor."
Researchers also assessed, for the first time, physicians' and patients' experience in using Oncotype DX, finding increased confidence by oncologists in 76 percent of the cases. Furthermore, 83 percent of patients felt the test influenced their treatment choice, regardless of whether it changed or reinforced their original decision. Overall, 95 percent of patients said that they were glad they received a Recurrence Score result to individualize their treatment.
"Oncotype DX Recurrence Score results, which have been validated through multiple large independent studies, provide an objective, individualized 'molecular fingerprint' of a woman's tumor in a way that both doctors and patients can easily understand," said Steven Shak, M.D., chief medical officer of Genomic Health. "With this study, we now have information from real-life experiences confirming the value of Oncotype DX in today's clinical practice. Based on these results and the more than 27,000 women who have used the test since it became available, we believe that Recurrence Score-guided therapy is setting a new standard for making informed treatment decisions for women with early-stage breast cancer."
The study, titled "Prospective multicenter study of the impact of the 21- gene recurrence score (RS) assay on medical oncologist (MO) and patient (pt) adjuvant breast cancer (BC) treatment selection," (ASCO Abstract #577) was presented June 2, 2007 at 2:00 p.m. by Shelly S. Lo, M.D., Assistant Professor, Division of Hematology/Oncology, Department of Medicine, Loyola University Chicago Stritch School of Medicine, Director, Breast Clinical Research Program, Cardinal Bernardin Cancer Center, Loyola University Health System, Maywood, Ill.
About Oncotype DX
Oncotype DX represents the first diagnostic multi-gene expression test service commercially available 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. Oncotype DX 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. To date, over 5,500 physicians have ordered a cumulative total of more than 27,000 tests and approximately 125 million lives are now covered by reimbursement contracts and agreements. 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 service, Oncotype DX(TM), 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 Oncotype DX to change treatment decisions, the belief that the use of Oncotype DX helps individualize treatment decisions and our belief that Recurrence Score-guided therapy is setting a new standard for making informed treatment decisions for women with early-stage breast 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: 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 March 31, 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.
