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Everist Genomics Announces External Validation of OncoDefender™-CRC Colorectal Cancer Recurrence Test
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Everist Genomics, has announced the positive results of the first external validation study of its OncoDefender-CRC colorectal cancer recurrence test. The study is being conducted by Mayo Validation Support Services, and is being coordinated with investigators and resources from all three Mayo Clinic sites.
The study, which will be presented in a poster presentation on Saturday at the American Society of Clinical Oncology's 2011 Gastrointestinal Cancers Symposium (ASCO-GI) in San Francisco, demonstrates that the OncoDefender-CRC assay can accurately predict individual recurrence risk in stage I and II colorectal cancer patients.
"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 post-surgical chemotherapy," said Lisa A. Boardman, M.D., Associate Professor of Medicine, Mayo Clinic College of Medicine and principal study investigator. The study's objective is 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."
About the study
The OncoDefender-CRC test provided 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 NCCN guidelines.
The study demonstrated that the computed recurrence score maintained significance (p=0.020) in differentiating colorectal cancer recurrence probability between high-and low-risk patients. In contrast, standard assessment measures did not maintain significance (p=0.315) 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."
"The OncoDefender-CRC test equips physicians with critical data about the genetic properties of a tumor, which when used in conjunction with standard pathological tests, enables clinicians to make better individualized treatment decisions for high-risk patients, while minimizing the exposure of low-risk patients to unnecessary, costly and potentially toxic chemotherapy and radiotherapy," said Peter F. Lenehan, M.D., Ph.D. Chief Medical Officer of Everist Genomics and principal study investigator.
"We are confident that the OncoDefender-CRC assay has the potential to emerge as a valuable tool in the clinical management for early stage colorectal cancer patients."
