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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

e. MMR/MSI is an alteration observed in approximately 15 percent of colon cancers. Patients with tumors identified as MSI high, or MMR deficient, are considered to be at low risk of recurrence.

With this result, QUASAR represents the largest study to confirm the importance of MMR/MSI in stage II colon cancer. MMR/MSI testing, although not routinely performed, is currently provided by many pathology laboratories. Genomic Health is evaluating its role in advancing the incorporation of MMR/MSI testing in colon cancer treatment planning.

The Oncotype DX colon cancer Recurrence Score is calculated from the quantitated expression of 7 recurrence genes and 5 reference genes in the tumor tissue and is expressed as an individual score ranging from 0 to 100. In the QUASAR validation study, the recurrence risk increased with increasing Recurrence Scores, with an average recurrence risk at three years of 12 percent, 18 percent and 22 percent in the pre-defined low, intermediate and high recurrence risk groups, respectively. The study further defined a continuous individualized recurrence risk at three years ranging from a low risk of 9 percent-11 percent to a high risk of 25 percent-27 percent.

Based on the positive QUASAR results, Genomic Health is proceeding with commercialization plans and expects to make the 12-gene Oncotype DX colon cancer test available to physicians and patients in early 2010. The company currently markets the widely-adopted Oncotype DX breast cancer test, clinically validated to predict the likelihood of recurrence and chemotherapy benefit in early-stage breast cancer.

More than 150,000 people worldwide are diagnosed with stage II colon cancer (also known as Dukes' Stage B) each year, including 30,000 to 40,000 in the United States alone, and the current treatment paradigm is unclear. The decision to treat patients with chemotherapy following surgery is
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SOURCE Genomic Health
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