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Genomic Health Announces New Data Reinforcing Clinical Utility of Oncotype DX(R) in Multiple Breast Cancer Populations
Date:12/15/2009

ntitative RT-PCR by Oncotype DX, to explore the association between polysomy 17 (extra copies of chromosome 17, a condition found in breast cancer patients that can complicate the interpretation of HER2 testing results), HER2 status and breast cancer death. Polysomy 17 was found in HER2-amplified tumors in approximately a third of cases. While differences were not statistically significant, HER2-positive patients with polysomy 17 tended to have a worse prognosis than other breast cancer patients. Quantitative RT-PCR by Oncotype DX for HER2 status is highly concordant with HER2 status assessed by FISH and therefore is an alternative to FISH.

About Oncotype DX®

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 November 2009, more than 8,000 physicians have ordered more than 120,000 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-nega
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SOURCE Genomic Health, Inc.
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