Genetic Test Evaluation

understanding how genetic tests impact patient management

Colvera (Clinical Genomics Technologies)

March 6, 2018

Colorectal cancer (CRC) is a major cause of cancer-associated morbidity and mortality in both men and women worldwide. In 2018, it is estimated that approximately 140,250 men and women in the United States will be diagnosed with colorectal cancer and 50,630 people will die from the disease. CRC is the second leading cause of cancer death in the United States. Prognosis relates to the stage of CRC, with the majority of individuals eligible for resection of their tumor. Approximately 30% to 50% of individuals with primary colorectal tumors will have a recurrence of their cancer following surgery. Surveillance is necessary, following diagnosis, in an effort to detect recurrence of disease for optimal outcome. The standard blood test for detecting recurrence is carcinoembryonic antigen (CEA) levels but some suggest it may have insufficient sensitivity. Additional tools have been developed to augment current methods to detect recurrence, with some evaluating cell-free circulating DNA in blood. One such test is the Colvera test, a methylation-specific assay that is designed to detect recurrence in patients with stage I through stage IV primary CRC. This report does not broadly address cell-free circulating DNA testing for CRC or specific gene associations that predict CRC recurrence.