SOURCE: Genomic Health

Genomic Health

February 26, 2010 08:00 ET

Genomic Health Announces Analysis Reinforcing Clinical Utility of Oncotype DX® Breast Cancer Test in Asia Pacific Patient Population

Findings Confirm Consistent Distribution of Oncotype DX Recurrence Score® Results Across Asia Pacific and United States Early-Stage Breast Cancer Patient Populations

REDWOOD CITY, CA and KYOTO, JAPAN--(Marketwire - February 26, 2010) - Genomic Health, Inc. (NASDAQ: GHDX) today announced results from an analysis demonstrating that the Oncotype DX® breast cancer test has similar clinical relevance in estrogen receptor-positive, early-stage breast cancer patients in Asia Pacific (AP) countries as it does in a comparable U.S.-based patient population. The analysis showed that this advanced diagnostic test consistently identified more than 50 percent of hormone receptor positive early-stage breast cancer patients in AP countries as having low Recurrence Scores, similar to what has been shown in U.S. and European clinical studies evaluating the Oncotype DX breast cancer test. These results were presented in a poster presentation at the Organisation for Oncology and Translational Research (OOTR) 6th Annual Conference in Kyoto, Japan, on February 26.

The Oncotype DX breast cancer test measures the expression of 21 genes of an individual breast cancer tumor to generate a Recurrence Score® that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for early-stage patients. As of February 2010, more than 8,000 physicians have used the Oncotype DX test for more than 135,000 breast cancer patients in more than 50 countries. The test was launched in the United States in 2004 where it has since been widely adopted for treating early-stage breast cancer, and is available worldwide.

"We believe these new findings, coupled with results from the multi-center Japanese validation study presented last April at the 2009 Kyoto Breast Cancer Consensus Conference, confirm the significant clinical benefit Oncotype DX provides in breast cancer treatment planning for early-stage breast cancer patients in Asia Pacific countries," said Calvin Chao, M.D., Medical Director, Genomic Health. "We believe these data support our efforts to expand the use of Oncotype DX throughout this important region of the world."

For this analysis, researchers at Genomic Health's CLIA (Clinical Laboratory Improvement Amendments) certified, CAP (College of American Pathologists) accredited laboratory analyzed tumor samples from 546 AP patients located in Japan, Taiwan, Hong Kong, Singapore, Thailand, India, Australia, and New Zealand. The tumor samples were submitted by physicians between 2006 and 2009. The AP Recurrence Score results, when compared to U.S. scores, showed a similar distribution of Recurrence Scores -- low Recurrence Score group (51 percent AP, versus 54 percent U.S.), intermediate Recurrence Score group (33 percent AP, versus 34 percent U.S.) and high Recurrence Score group (16 percent AP, versus 13 percent U.S.). These findings were consistent with results from numerous U.S. and international validation and confirmatory studies evaluating Oncotype DX, despite observed differences in practice pattern management of early-stage breast cancer.

The table below illustrates the distribution of low, intermediate and high Recurrence Score (RS) risk groups in the Asia Pacific and the U.S.:

                                  AP (n=546)    US ( > 110,000)
RS 0-17                                  51%                54%
RS 18-30                                 33%                34%
RS greater than or equal to 31           16%                13%

About the Oncotype DX® Breast Cancer Test
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 February 2010, more than 8,000 physicians have ordered more than 135,000 tests in over 50 countries, 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 applicability of clinical study results to actual outcomes, the belief the Oncotype DX breast cancer test provides a significant clinical benefit in treatment planning for early-stage breast cancer patients in Asia Pacific countries and the belief that the study supports the company's efforts to expand use of Oncotype DX into breast cancer treatment planning in the Asia Pacific region. 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 risk that we may not be able to expand use of Oncotype DX in the Asia Pacific region; our ability to obtain or maintain sufficient levels of reimbursement for our tests; the risks and uncertainties associated with the regulation of our 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.

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