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Genomic Health Announces Study Establishing the Utility of Oncotype DX(R) in Node-Negative and Node-Positive Breast Cancer Patients Treated with Aromatase Inhibitors

SAN ANTONIO, Dec. 13 /PRNewswire-FirstCall/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced findings from a European study demonstrating that the Oncotype DX Recurrence Score(R) result is a significant independent predictor of distant recurrence in both node-negative and node-positive, hormone receptor-positive breast cancer patients who are treated with the aromatase inhibitor anastrozole or with tamoxifen. Researchers from the Royal Marsden Hospital in London discussed results today in an oral presentation at the 31st Annual San Antonio Breast Cancer Symposium.

Oncotype DX is a multi-gene expression test that physicians currently use to predict the likelihood of chemotherapy benefit as well as the likelihood of recurrence for women with early stage breast cancer. In this prospectively- designed study, researchers used Oncotype DX to analyze tumor samples from 1,231 patients in the ATAC (Arimidex(R), Tamoxifen, Alone or in Combination) trial, a landmark study that established the wide use of aromatase inhibitors for adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer.

"Our multivariate analysis confirms that along with other standard measures such as tumor size, Oncotype DX contributes independently to providing a more complete picture of prognosis," said Mitch Dowsett, Ph.D., Royal Marsden Hospital and Team Leader at the Breakthrough Breast Cancer Research Centre in London. "Physicians can take this information into account when making chemotherapy treatment decisions for both node-negative and node- positive early stage breast cancer patients planned for either anastrozole or tamoxifen treatment."

The study assessed 9-year distant recurrence 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 more than 4 nodes). Researchers, with support from the UK's leading breast cancer charity, Breakthrough Breast Cancer, and AstraZeneca, collected tumor blocks, mainly from patients in the United Kingdom, and tested the significance of adding the Recurrence Score result to a clinical model consisting of age, tumor size, grade and treatment, as well as the Adjuvant! Online risk assessment tool.

The study indicated that the Oncotype DX Recurrence Score (RS) result showed statistically significant prognostic value beyond that provided by Adjuvant! Online in both node-negative (p<0.001) and node-positive (p=0.003) patients. The greater efficacy of anastrozole observed in the parent ATAC trial and the similar hazard ratios for the RS in both treatment arms from this study suggests a lower risk of recurrence in patients treated with aromatase inhibitors. In addition, for any RS result, the likelihood of distant recurrence increases with the number of positive nodes.

"This study is the largest that Genomic Health has conducted to date, reinforcing our commitment to continue adding value to the Oncotype DX breast cancer assay by studying additional patient populations and treatment regimens relevant to current clinical practice," said Steven Shak, M.D., chief medical officer of Genomic Health. "These results, combined with the suite of clinical evidence that we and our clinical partners generated over the past five years, reinforce our belief that Oncotype DX is an indispensable tool when making treatment decisions for node-negative patients and in certain node-positive patients."

Earlier this week, Genomic Health and research collaborators presented three additional studies. Highlights include:

    *    An oral presentation on Thursday, December 11 suggested that
         GRB7-dependent pathways are potential therapeutic targets for
         triple-negative breast cancer, a subtype that does not express genes
         for estrogen receptor (ER), progesterone receptor (PR) or HER2.
         Triple negative breast cancer is considered to be more aggressive
         and difficult to treat than hormone receptor-positive or HER2-
         positive breast cancers. These results need to be confirmed with
         future trials.
    *    On Friday, December 12 researchers from Genomic Health presented
         results from a study that demonstrated quantitative RT-PCR analysis
         is possible in ductal carcinoma in situ (DCIS) that is adjacent to
         invasive ductal carcinoma (IDC).  Of the 30 ER-positive breast
         cancer tumor samples that were identified, 90 percent had sufficient
         RNA for Oncotype DX analysis, after separating the DCIS and IDC
         tissues.  While DCIS adjacent to invasive breast cancer demonstrated
         similar quantitative biology for the genes evaluated in the Oncotype
         DX assay, future studies to evaluate Oncotype DX and recurrence
         rates in DCIS are needed.
    *    A separate study, also presented on Friday, December 12, found that
         multiple single nucleotide polymorphisms (SNPs) in the genes that
         encode ER were not associated with the level of ER expression in
         breast cancer, suggesting that differences in ER expression between
         individual tumors are likely a result of factors other than
         inherited gene mutations.

About Oncotype DX(R)

Oncotype DX is the first and only multi-gene 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. Oncotype DX has been extensively evaluated in eleven clinical studies involving more than 4,000 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, 7,500 physicians have ordered more than 75,000 tests, and both Medicare and private health plans covering approximately 90 percent of U.S. insured lives provide reimbursement for Oncotype DX through contracts, agreements or policy decisions. Both the American Society of Clinical Oncology (ASCO) 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

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 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

About The Royal Marsden Hospital

The Royal Marsden Hospital was the first hospital in the world dedicated to cancer treatment and research into the causes of cancer. Today the hospital, which is based in London and in Sutton, sees over 40,000 patients from the UK and abroad each year. A world leader in research, drug trialing and diagnostics, The Royal Marsden provides inpatient, day care and outpatient services for all areas of cancer treatment.

About Breakthrough Breast Cancer

Breakthrough Breast Cancer is the UK's leading breast cancer charity committed to fighting breast cancer through research, campaigning and education. In 1999 Breakthrough established the UK's first dedicated breast cancer research centre. The Breakthrough Toby Robins Breast Cancer Research Centre is housed in the Mary-Jean Mitchell Green building at The Institute of Cancer Research and was set up in association with the Royal Marsden Hospital in London. The centre is led by Professor Alan Ashworth FRS. For more information about Breakthrough Breast Cancer, please visit

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 company's belief that conducting studies in additional patient populations and treatment regimens adds value to the Oncotype DX breast cancer assay, the company's belief that clinical evidence and the results of the study reinforce that Oncotype DX is an indispensable tool when making treatment decisions for node-negative and certain node-positive breast cancer patients, and the conclusions from studies needing additional trials or research and the ability of the company to conduct such studies or research . These risks and uncertainties include, but are not limited to: the results of additional clinical studies; the applicability of clinical study results to actual outcomes; the risk that the company may not obtain sufficient levels of reimbursement for any future tests it may develop; the company's ability to develop and commercialize new products; the risks and uncertainties associated with the regulation of the company's tests by FDA; the company's ability to obtain capital when needed; the company's history of operating losses and the other risks set forth in its filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the three-month period ended September 30, 2008. 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, Inc.
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