Genomic Health’s colon cancer assay study meets primary endpoint

Genomic Health, a life science company, has reported 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. Detailed results from the Quasar study are scheduled to be presented during the upcoming ASCO annual meeting in Orlando, Florida.

Based on these positive results, Genomic Health 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.

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, designed to predict which patients experience greater relative benefit of 5-fluorouracil/leucovorin following surgery.

Steve Shak, chief medical officer of Genomic Health, said: 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. With these results, we believe we can introduce the promise of genomics into clinical practice for colon cancer as we did in breast cancer.