Multi-gene Expression Assay for Predicting Recurrence in Colon Cancer
DESCRIPTION
The multi-gene expression assay is a 12-gene expression test that is intended to be used as an aid in identifying stage II (i.e., Dukes B) colon cancer individuals who may experience recurrence after surgery and therefore may benefit from additional treatment. Colorectal cancer is classified as stage II when it has spread outside the colon and/or rectum to nearby tissue, but is not detectable in the lymph nodes and has not metastasized to distant sites.
An example of this testing is the Oncotype DX® colon cancer test. This test is being offered as a laboratory-developed assay service conducted in California at the Genomic Health CLIA-licensed clinical laboratory.
POLICY
The 12-gene expression test for the treatment of other conditions/diseases, including, but not limited to, predicting the likelihood of disease recurrence for stage II colon cancer individuals following surgery is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
There is a lack of published evidence-based randomized controlled trials and well-designed studies to determine whether the use of the multi-gene expression assay for predicting recurrence in colon cancer improves net health outcomes.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2011). Multi-gene expression assay for predicting recurrence in colon cancer (2.04.61). Retrieved March 19, 2012 from BlueWeb. (7 articles and/or guidelines reviewed)
Chun, P., & Wainberg, Z. A. (2009). Adjuvant chemotherapy for stage II colon cancer: The role of molecular markers in choosing therapy. Gastrointestinal Cancer Research, 3 (5), 191-196.
National Comprehensive Cancer Network. (2012, March). NCCN clinical practice guidelines in oncology™. Colon cancer (V.3.2012). Retrieved March 19, 2012 from http://www.nccn.org/professionals/physician_gls/PDF/colon.pdf.
ORIGINAL EFFECTIVE DATE: 10/9/2010
MOST RECENT REVIEW DATE: 5/10/2012
ID_BA
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