Gene-Based Test Predicts Recurrence of Cancer

A gene-based molecular assay is able to predict accurately whether malignancy will recur in stage I or stage II colorectal cancer (CRC) patients.

The test provides higher diagnostic accuracy than standard of care assessment measures in predicting probability of recurrence, with a statistically significant improvement in specificity and prognostic accuracy as compared to US National Comprehensive Cancer Network guidelines, (NCCN; Fort Washington, PA, USA).

An external study performed by the Mayo Validation Support services (Rochester, MN, USA) validated the OncoDefender CRC as a predictive test. The test examines expression levels of a panel of genes extracted from cancer tissue taken at the time of surgery, and uses a proprietary computer-generated decision rule to identify patients who are at risk of recurrence accurately and reliably. Ultimately, this prognostic test serves as a clinical decision support tool, helping physicians and patients determine an appropriate individual treatment plan and to evaluate the need for additional therapy.

The study demonstrated that the computed recurrence score maintained statistical significance in differentiating colorectal cancer recurrence probability between high-and low-risk patients. In contrast, standard assessment measures did not maintain significance in differentiating colorectal cancer recurrence probability in this population. Among the key performance indicators of the study, patients who were identified as "high risk" by the OncoDefender-CRC assay had a significantly higher probability of recurrence within 36 months than patients identified as "low risk" did. The OncoDefender CRC assay is produced by Everist Genomics (Ann Arbor, MI, USA) who expect to make the test commercially available in the first quarter of 2011.

Lisa A. Boardman, MD, the principal investigator in the study, said, "One of the most pressing challenges for physicians who treat colorectal cancer is the early identification of patients who are at risk of recurrence and could potentially benefit from prophylactic postsurgical chemotherapy. The study's objective was to develop an effective tool to guide treatment decisions and for identifying those patients most likely to benefit from adjuvant therapy following surgical resection of tumor tissue." The study was presented at the American Society of Clinical Oncology's 2011 Gastrointestinal Cancers Symposium, held in January 2011, in San Francisco, CA, USA.

Related Links:
National Comprehensive Cancer Network
Mayo Validation Support Services
Everist Genomics