SAN ANTONIO, Dec. 9 /PRNewswire-FirstCall/ -- Genomic Health, Inc. today announced results of a community-based, investigator-sponsored study that demonstrated its Oncotype DX(TM) 21-gene panel breast cancer test, which quantifies the likelihood of recurrence and predicts chemotherapy benefit for a large portion of early-stage breast cancer patients, changed treatment decisions in this patient population. These results were presented today at the 28th Annual San Antonio Breast Cancer Symposium.
The study evaluated the experience of four oncologists treating 68 early-stage, estrogen-receptor-positive breast cancer patients and found that knowledge of the Oncotype DX Recurrence Score(TM), a score between 0-100 assigned based on a quantitative measurement of the expression of 21 genes, altered the adjuvant treatment administered to 25 percent of patients compared to physicians’ original recommendations.
“Our findings clearly indicate that assessing a woman’s individual Recurrence Score in addition to standard measures, such as patient age, tumor size and tumor grade, is critical to making well-informed treatment decisions,” said Ruth Oratz, M.D., clinical associate professor, NYU School of Medicine, and lead author of the study. She and her colleagues conducted the study when she was at Rocky Mountain Cancer Center. “We were impressed to see just how often this commercially available and clinically validated test changed the course of treatment. Oncotype DX provides my patients with valuable information about their individual cancer and greater confidence in their treatment selection.”
Treatment recommendations by physicians changed for 14 of the 68 patients in this study. Specifically, seven changed from chemotherapy in combination with hormone therapy to hormone therapy alone, and seven changed from hormone therapy alone to chemotherapy in combination with hormone therapy. The decision to switch from chemotherapy and hormone therapy to hormone therapy alone was associated with low Recurrence Scores, while the decision to switch from hormone therapy to chemotherapy in combination with hormone therapy was associated with high Recurrence Scores.
“We are pleased to see evidence that Oncotype DX is making an impact in current clinical practice,” said Steven Shak, M.D., chief medical officer, Genomic Health. “This new study adds to the large body of clinical evidence that provides women with early-stage breast cancer and their doctors the confidence to make personalized treatment decisions based on the Oncotype analysis of their individual cancer.”
The 28th annual San Antonio Breast Cancer Symposium is being held at the Henry B. Gonzalez Convention Center in San Antonio, Texas, from December 8-11, 2005. For more information, visit www.sabcs.org.
About Oncotype DX
Oncotype DX represents 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 patient survival within 10 years of diagnosis and the likelihood of chemotherapy benefit. The test 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. 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 diagnostic tests for cancer that allow physicians and patients to make individualized treatment decisions. In 2004, Genomic Health launched its first test, 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 Oncotype DX on clinical practice and treatment decisions 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. These risks and uncertainties include the risks set forth in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2005, which is on file with the Securities and Exchange Commission and is available on the SEC’s website at www.sec.gov. 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, +1-415-595-9407, or Emily@weisscommpartners.com,or Katie Compa, +1-646-644-1567, or kcompa@weisscommpartners.com, both ofWeissComm Partners, for Genomic Health; or Brad Cole of Genomic Health,+1-650-569-2281, or investors@genomichealth.com