Genomic Health Announces Commencement of QUASAR Clinical Validation Study for Oncotype DX(R) Colon Ca...( - Company to Provide Update on Pipeli...)

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REDWOOD CITY, Calif., Jan. 12 /PRNewswire-FirstCall/ -- Genomic Health, Inc. (Nasdaq: GHDX) announced today that it has initiated an independent clinical validation study for its 18-gene Oncotype DX(R) colon cancer assay. Utilizing more than 1,200 patient samples from the landmark QUASAR trial, the validation study will use prospectively defined endpoints to assess the clinical utility of the Oncotype DX colon cancer assay to predict likelihood of recurrence for stage II colon cancer patients treated with surgery alone and the magnitude of treatment benefit with chemotherapy following surgery. Results from the study are expected to be reported in the second half of 2009.

Stage II colon cancer (also known as Dukes' Stage B) affects an approximately 30-40,000 people each year in the United States and the current treatment paradigm is unclear. About a third of patients receive adjuvant chemotherapy, usually 5-fluorouracil/leucovorin (5FU/LV) or combinations that include 5FU/LV; however, research indicates that only 2-4 percent benefit from this treatment, which has significant associated toxicity. While there are existing clinical markers traditionally associated with higher-risk in colon cancer patients, there is no clinically validated genomic test available that predicts the likelihood of recurrence or magnitude of chemotherapy benefit for individual patients.

"There is a critical need for more targeted approaches in treating the tens of thousands of patients with stage II colon cancer and the initiation of this study brings us one step closer to delivering a tool that may do that," said Steven Shak, M.D., chief medical officer, Genomic Health. "Over the past two years we have partnered with the National Surgical
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