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Breast chemotherapy response assay

This article was originally published in The Gray Sheet

Executive Summary

Genomic Health's Oncotype Dx breast cancer recurrence assay stratifies chemotherapy benefit in 651 patients studied by the National Surgical Adjuvant Breast & Bowel Project, the Redwood City, Calif. firm announces with NSABP at the San Antonio Breast Cancer Symposium Dec. 10. The National Cancer Institute-supported trial showed that high recurrence scores - associated with 25% of patients with "node-negative, estrogen receptor-positive breast cancer" - determine "a large absolute benefit from chemotherapy." Low recurrence scores were linked with minimal benefit and represented about 50% of such patients. Unveiling of the data coincided with early release of an article to be published in the New England Journal of Medicine Dec. 30. The NEJM study is a large validation trial confirming that the 21-gene panel predicts breast cancer recurrence in tamoxifen-treated, node-negative patients. Oncotype Dx was approved under the Clinical Laboratory Improvement Amendments (CLIA) in January...

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