Genomic Health has reported the commercial availability of its Oncotype DX colon cancer test, a multigene expression test developed for the assessment of risk of recurrence in patients with stage II disease.
The company claims that the 12-gene advanced diagnostic test is clinically validated to predict individual recurrence risk in stage II colon cancer patients following surgery, as reported at the 2009 American Society of Clinical Oncology (ASCO) meeting.
The Oncotype DX colon cancer test is the multigene expression test commercially available that has been clinically validated to predict risk of recurrence in patients with stage II colon cancer.
The National Surgical Adjuvant Breast and Bowel Project (NSABP) conducted three development studies and Cleveland Clinic conducted one development study, all of which were funded by Genomic Health, analyzing 761 genes from 1,851 patients with stage II colon cancer. The final set of seven recurrence and five reference genes were then independently evaluated in 1,436 stage II colon cancer patients in the QUASAR validation study.
Steven Shak, chief medical officer of Genomic Health, said: “We are pleased to deliver a new model for assessing recurrence risk in patients diagnosed with stage II colon cancer that is based on rigorous scientific research conducted with our clinical collaborators at the NSABP, the Cleveland Clinic and the QUASAR study group.
“We believe the availability of the Oncotype DX colon cancer test will allow physicians, for the first time, to go beyond the limited set of clinical and pathologic markers they currently use in order to make a more precise risk assessment in the treatment planning for stage II colon cancer patients.”