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Genomic Health Announces Data Supporting Use of Oncotype DX(R) to Accurately Assess HER2 Gene Expression in Breast Cancer Patients
Date:9/6/2008

utility of Oncotype DX by providing single gene reporting for the expression of estrogen and progesterone receptors. The company expects to further increase the clinical utility of its test by including single gene reporting for quantitative HER2 gene expression in all Oncotype DX reports by the end of 2008.

The first study (Abstract 13), conducted by Genomic Health and collaborators from the Eastern Cooperative Oncology Group and sanofi-aventis, demonstrated a high degree of overall concordance -- 95 percent -- between central IHC and quantitative RT-PCR using Oncotype DX for determining HER2 status. The study analyzed 755 patients with 0 to 3 positive lymph nodes who were enrolled in Intergroup study E2197, a large adjuvant breast cancer trial evaluating two different chemotherapy regimens.

The second study (Abstract 41) found a high degree of concordance -- 97 percent -- between RT-PCR using Oncotype DX and central laboratory FISH assessment of HER2 status. The study was conducted by Genomic Health and collaborators from Kaiser Permanente; the University of California, San Francisco; and PhenoPath, Inc. HER2 measurement was assessed by central FISH and quantitative RT-PCR using Oncotype DX in 568 patients from a large Kaiser Permanente case-control study (Habel et al., Breast Can Res 2006). As previously reported, this study also found a significantly greater risk of breast cancer death in patients who were determined to be HER2-positive by Oncotype DX. Since patients in both these studies did not have the option of Trastuzumab treatment, the direct relationship between HER2 and Trastuzumab treatment response could not be assessed.

"During tumor sample preparation for IHC or FISH analysis, variability in the preanalytic process may lead to differences in results and interpretation, and, consequently, to potentially inappropriate treatment decisions," said Frederick L. Baehner, M.D., Senior Pathologist at Genomic Health and lead author of both
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SOURCE Genomic Health, Inc.
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