Genomic Health, Inc. has announced that the QUASAR validation study met its primary endpoint to predict the likelihood of recurrence for stage II colon cancer patients following surgery, and that the colon cancer Recurrence Score provided additional independent clinical value beyond standard measures of risk. Based on these positive results, the company is initiating the necessary work in its Clinical Reference Laboratory and proceeding with commercialization plans to make the Oncotype DX colon cancer Recurrence Score available to physicians and patients in early 2010. Detailed results from the QUASAR study are scheduled to be presented during the upcoming ASCO annual meeting in Orlando. While meeting the primary endpoint in predicting recurrence, the study did not meet a second endpoint evaluating a separate score, with a distinct set of genes, intended to predict which patients experience greater relative benefit of 5-fluorouracil/leucovorin (5FU/LV) following surgery. "The positive findings of this large QUASAR validation study represent a significant step forward in better understanding the biology of a disease that is a leading cause of cancer related death," said Steve Shak, M.D., chief medical officer of Genomic Health. "With these results, we believe we can introduce the promise of genomics into clinical practice for colon cancer as we did in breast cancer, and are pleased that the study has been accepted for presentation at the upcoming ASCO annual meeting in Orlando, Florida."