Genomic Health Announces Publication of Study Using Oncotype DX(R) in Node-Negative and Node-Positive Breast Cancer Patients Treated With Aromatase Inhibitors

REDWOOD CITY, Calif., March 8 /PRNewswire-FirstCall/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced the publication of positive results from a large international study which demonstrated that the Oncotype DX® breast cancer Recurrence Score® (RS) result is a significant independent predictor of distant recurrence in both node-negative and node-positive, hormone receptor-positive, postmenopausal breast cancer patients who are treated with either anastrozole or tamoxifen. The study, originally presented at the San Antonio Breast Cancer Symposium in 2008, was published online today in the Journal of Clinical Oncology.  

The Oncotype DX breast cancer test measures the expression of 21 genes of an individual tumor to generate an RS result that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for early-stage breast cancer patients.  As of December 2009, more than 8,000 physicians had used more than 135,000 Oncotype DX breast cancer tests for treatment planning.

"We believe the results of this study reinforce the important role of Oncotype DX in making individualized treatment decisions for early stage breast cancer patients with node-negative and node-positive disease," said Steven Shak, M.D., chief medical officer of Genomic Health.  "Oncotype DX testing allows physicians and patients to make a more informed decision on whether to add chemotherapy, yielding a potential savings to the U.S. healthcare system of approximately $2,000 in direct costs per patient."

The study used Oncotype DX to analyze tumor samples from 1,231 patients involved in the landmark ATAC (Arimidex®, Tamoxifen, Alone or in Combination) trial, which established the extensive use of aromatase inhibitors for adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer. Nine-year distant recurrence was assessed for women in the anastrozole and tamoxifen monotherapy arms of the ATAC trial, including patients with disease that had spread to the lymph nodes (0 nodes, 1-3 nodes and 4 or more nodes).

Researchers collected tumor blocks primarily from patients in the United Kingdom and tested the significance of adding the RS result to a clinical model consisting of age, tumor size, grade and treatment, as well Adjuvant! Online, a valid risk assessment tool that evaluates clinical variables to help physicians and patients assess the risks and benefits of getting additional therapy after surgery.

Results indicated that the RS result provided statistically significant prognostic value beyond that provided by Adjuvant! Online in node-negative (p<0.001) patients. While the study confirmed the performance of the RS result in a large contemporary patient population of postmenopausal hormone receptor-positive women treated with tamoxifen, it also demonstrated that the established relationship between the RS and risk of distant recurrence for tamoxifen may now be applied to anastrozole. The greater efficacy of anastrozole observed in the parent ATAC trial and the analysis of the RS results in both treatment arms from this study suggests a lower risk of recurrence in patients treated with aromatase inhibitors. Additionally, as consistent with prior OncotypeDX results in node-positive breast cancer, for any RS result, the likelihood of distant recurrence increases with the number of positive nodes.

About Oncotype DX®

The Oncotype DX breast cancer test is the only multigene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. Additionally, the test report provides quantitative scores for certain individual genes. The Oncotype DX breast cancer test has been extensively evaluated in thirteen clinical studies involving more than 4,000 breast cancer patients worldwide, 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. As of December 2009, more than 8,000 physicians in over 50 countries had ordered more than 135,000 tests, and both Medicare and private health plans covering over 90 percent of U.S. insured lives provide reimbursement for Oncotype DX for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive through contracts, agreements or policy decisions. Both the American Society of Clinical Oncology and the National Comprehensive Cancer Network recommend 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 www.oncotypedx.com.  

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) 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 the Oncotype DX® breast cancer test, which has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. In addition to the widely adopted Oncotype DX breast cancer test, Genomic Health launched its Oncotype DX colon cancer test in January 2010. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit 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 belief that the study data support the clinical utility of our test in postmenopausal breast cancer patients with node-negative or node-positive, hormone receptor-positive disease who are treated with either anastrozole or tamoxifen, the belief that using Oncotype DX for breast cancer can allow better-informed decisions to avoid the toxicity and medical costs of chemotherapy, and the amount of the potential cost savings, the belief that the RS result provided statistically significant prognostic value beyond that provided by Adjuvant! Online, 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, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to:  the risks and uncertainties associated with the regulation of the company's tests; the applicability of clinical study results to actual outcomes; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2009. 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.

SOURCE Genomic Health