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Genomic Health Announces Commencement of QUASAR Clinical Validation Study for Oncotype DX(R) Colon Cancer Assay
Date:1/12/2009

Adjuvant Breast and Bowel Project (NSABP) and the Cleveland Clinic Foundation to evaluate more than 1,800 patients and 760 candidate genes to select the final 18-gene set for the Oncotype DX colon cancer assay. In developing this assay we have applied the same rigor and technology used to validate the Oncotype DX breast cancer assay, a test that has helped guide treatment decisions for more than 75,000 women with early-stage disease."

To date, Genomic Health has completed four development studies to identify and select the 18 genes for the Oncotype DX colon cancer assay. The validation study is utilizing samples from QUASAR, the largest study of its kind. An international, multi-center trial, QUASAR examined the benefit associated with adjuvant 5FU/LV for patients with stage II colon cancer. The majority of samples for this analysis of the Oncotype DX colon cancer assay are from the United Kingdom.

Unlike the Oncotype DX breast cancer assay that captures both recurrence and treatment benefit in one Recurrence Score, the prognostic and predictive genes in the colon cancer assay do not overlap. As such, this colon cancer assay was designed to generate both a prognostic Recurrence Score and predictive Treatment Score. Researchers will evaluate the association of the Recurrence Score with recurrence in stage II colon cancer patients treated with surgery alone. They will also evaluate the association of the Treatment Score with the magnitude of chemotherapy benefit in patients treated with adjuvant 5FU/LV chemotherapy.

"In the absence of reliable prognostic and predictive tools to select stage II colon cancer patients for adjuvant chemotherapy, over- and under-treatment present significant challenges," said Alan Venook, M.D., Professor of Clinical Medicine, Gastrointestinal Oncology Research Program at UCSF Medical Center. "With increasing numbers of people being diagnosed with early-stage disease, a well-valida
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SOURCE Genomic Health, Inc.
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