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Genomic Health (GHDX) Announces Results of Oncotype DX Breast Cancer Test in Asia Pacific Countires

February 26, 2010 8:36 AM EST
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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.

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