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Genomic Health Presents Study Data On Oncotype DX Test

Genomic Health has presented 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 US based patient population.

The analysis showed that this advanced diagnostic test consistently identified more than 50% of hormone receptor positive early-stage breast cancer patients in AP countries as having low Recurrence Scores, similar to what has been shown in US and European clinical studies evaluating the Oncotype DX breast cancer test.

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. The test has been launched in the US in 2004 where it has since been widely adopted for treating early-stage breast cancer, and is available worldwide.

For the 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 US scores, showed a similar distribution of Recurrence Scores low Recurrence Score group, intermediate Recurrence Score group and high Recurrence Score group. These findings were consistent with results from numerous US and international validation and confirmatory studies evaluating Oncotype DX, despite observed differences in practice pattern management of early-stage breast cancer.

Calvin Chao, medical director of Genomic Health, said: “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. We believe these data support our efforts to expand the use of Oncotype DX throughout this important region of the world.”