A clinically validated assay that can help predict recurrence risk in Stage II Colon Cancer.

Overview

Oncotype DX Colon Cancer Assay is a new, gene-based diagnostic test that helps men and women with Stage II colon cancer learn more about the biological features of their specific tumor that indicate how likely it is that a member´s cancer may recur in the future (recurrence). Coupled with other pieces of information, the results from the Oncotype DX test can help members and their providers make personalized decisions about whether or not to include adjuvant chemotherapy in their treatment plan following surgery.

The Oncotype DX Colon Cancer test is the first multigene expression test commercially available that has been clinically validated to predict risk of recurrence in patients with stage II colon cancer. Genomic Health collaborated with the National Surgical Adjuvant Breast and Bowel Project and the Cleveland Clinic on a total of four development studies involving more than 1,800 patients with stage II colon cancer. The final gene panel was then independently evaluated in more than 1,400 stage II colon cancer patients in the QUASAR validation study.

Reimbursement

As of September 29, 2011, Palmetto GBA, the designated national Medicare contractor for the Oncotype DX colon cancer test, has established a formal coverage policy for all Medicare patients and can be referenced by clicking here. The coverage is effective for claims for services performed on or after September 18, 2011. The Oncotype DX Colon Cancer Assay is also covered by four major private payers.