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Genomic Health's Oncotype DX(R) Colon Cancer Test Predicts Individualized Recurrence Risk for Stage II Colon Cancer Patients
Date:5/14/2009

based on an assessment of how likely their disease is to recur. However, accurately identifying those patients with high recurrence risk is a critical issue for physicians because the available markers to determine likelihood of disease recurrence are limited, resulting in both over-treatment and under-treatment of patients following surgery.

"Patients with stage II colon cancer are often faced with tough decisions about treatment," said Carlea Bauman, President of C3: Colorectal Cancer Coalition. "These findings will help patients and their physicians make decisions based on each patient's potential risk. This is critically important to patients facing treatment options that can be life-altering. Patients want the assurance that they are receiving the most appropriate course of treatment for their individual disease."

Developmental Work Conducted by National Surgical Adjuvant Breast and Bowel Project (NSABP) and Cleveland Clinic

For its colon cancer program, Genomic Health and its collaborators used the same rigorous clinical development strategy and standardized quantitative technology designed for the company's Oncotype DX breast cancer test. The NSABP conducted three development studies and Cleveland Clinic conducted one development study, which was funded by Genomic Health, analyzing 761 genes from 1,851 patients with stage II colon cancer. Detailed analysis of gene expression and colon cancer recurrence was performed to identify specific genes with the potential to predict the likelihood of cancer recurrence and response to chemotherapy. The 761 candidate genes were also examined to determine whether they would be useful beyond other key variables including tumor stage, tumor grade, lymph nodes examined and MMR/MSI.

The final set of seven recurrence, six treatment and five reference genes were then independently evaluated in 1,436 stage II colon cancer patients in the
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SOURCE Genomic Health
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