Everist Genomics today announced the worldwide commercial availability of its OncoDefender-CRC colorectal cancer assay, the first and only molecular prognostic test capable of accurately predicting the risk of recurrence of cancer in patients previously treated with surgical resection of a Stage I/II colon cancer tumor or Stage I rectal cancer tumor. The OncoDefender-CRC test examines expression levels of a panel of genes extracted from formalin-fixed paraffin-embedded 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. Patients identified by OncoDefender-CRC at high-risk of cancer recurrence may benefit from adjuvant therapy or other more aggressive treatment options, as reported at the 2011 American Society of Clinical Oncology (ASCO) meeting.
"We are pleased to deliver a new molecular prognostic test capable of assessing recurrence risk in early stage colorectal cancer patients, including the neglected stage I subset, where the lack of positive predictive prognostics presents a significant unmet need," said Prasad Sunkara, Ph.D., Chief Executive Officer of Everist Genomics. OncoDefender-CRC was developed through extensive clinical research and assay validation studies involving over 500 patients from around the world. "OncoDefender-CRC will help physicians make patient management decisions that promptly and reliably direct the most effective treatment to those individual Stage I/II colon cancer and Stage I rectal cancer patients at high risk for tumor recurrence, while minimizing the exposure of low-risk patients to unnecessary, costly, and potentially toxic chemotherapy and/or radiotherapy."
Traditional standards for assessing a patient's risk of cancer recurrence have depended solely on the cancer's anatomical characteristics (e.g. tumor size, depth of tissue invasion and migration to other organs and tissues). OncoDefender-CRC determines the tumor's aggressiveness based on its genetics makeup and molecular profile. The clinical data indicate that the performance characteristics of the OncoDefender-CRC test are superior to other methods currently in use to predict recurrence. Furthermore, studies demonstrate that high-risk OncoDefender-CRC results correlate with cohorts colorectal cancer patients that recur within 3 years of surgery, while low-risk results correlate more closely with those patients without recurrence within 3 years. As a further indication of the overall accuracy and robustness of OncoDefender-CRC, the test does not report indeterminate or "no-call" results from any samples that meet quality acceptance and processing criteria.
According to Peter F. Lenehan, M.D., Ph.D. Chief Medical Officer of Everist Genomics, accurate assessment of the risk of recurrence for Stage I and Stage II colorectal cancer patients addresses a significant unmet medical need. "Knowing a patient's risk of recurrence after surgery directly informs decisions regarding post-operative treatment and the aggressiveness of follow-up," said Dr. Lenehan. "Molecular prognostics are valuable tools that reflect a tumor's underlying biology better than traditional histopathological examination and staging. The OncoDefender-CRC test is an important medical advance because it helps physicians identify aggressive tumors amongst stage I and II colorectal cancer patients. Physicians now have a valuable new prognostic tool to help them identify patients at risk of recurrence and most likely to benefit from adjuvant therapy."
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