These findings address a large unmet need in the treatment of colon cancer by validating a clinical tool which can significantly improve risk assessment in the treatment planning for stage II colon cancer patients. The company announced these data in conjunction with ASCO’s advance presscast presentation and subsequent embargo lift of all accepted abstracts and looks forward to the full data presentation at ASCO’s annual meeting in Florida.

These clinical results represent an important advancement in bringing personalized medicine to the tens of thousands of people who suffer from stage II colon cancer, as the availability of precise markers to determine likelihood of recurrence risk are limited in today’s clinical setting, said David Kerr, M.D., DSc, professor of cancer medicine at the University of Oxford. With these results we have a validated multi-gene test to predict colon cancer recurrence that, when available, will enable physicians to better select patients for aggressive treatment beyond surgery.

David Kerr, Richard Gray, Ph.D., professor of medical statistics at the University of Birmingham, and Philip Quirke, B.M., M.D. FRCPath, professor of pathology and tumor biology at the University of Leeds, are the principal investigators of the QUASAR validation study.

A second endpoint evaluating a separate score, with a distinct set of genes, designed to predict which patients experience greater proportional benefit of 5-fluorouracil/leucovorin (5FU/LV) following surgery was not met (p=0.19).

The positive findings from the QUASAR validation study strongly support a new paradigm for assessing recurrence risk in stage II colon cancer, emphasizing the critical role of three measures, Recurrence Score, MMR/MSI and T-stage, said Steve Shak, M.D., chief medical officer of Genomic Health. We believe the Oncotype DX colon cancer Recurrence Score will provide the greatest clinical utility for treatment selection in the more than 70 percent of patients for whom MMR/MSI and T-stage are uninformative.

The Oncotype DX colon cancer Recurrence Score maintained its independent significance in predicting the likelihood of recurrence risk (p=0.008), when analyzed in the presence of all the other factors. T4 stage (p=0.005) and MMR deficiency (p<0.001) were also independently beneficial in predicting recurrence, and together comprise approximately 25 percent of patients. T4 stage indicates growth of the tumor through the wall of the bowel and is associated with higher risk of recurrence. 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 the 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.

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 p