"What if we had a test that would accurately identify patients with early-stage high-risk tumors and you treat these patients with surgical removal of their tumor and add chemotherapy?" he asked. "What would happen to survival rates in these patients? The answers to these questions were remarkable."
The scientific team at Everist Genomics identified research which revealed that patients with high-risk Stage 2 colorectal tumors can benefit greatly from adjuvant therapy, with three-year disease-free survival rates increasing from 84.7 percent in patients that did not receive chemotherapy to 96.4 percent in those that did. Improvements in five-year overall survival rates increase from 86.4 percent to over 98 percent.
These insights led the scientists at Everist Genomics to commence a two-year development program to discover the combination of genes and their expression levels that would identify patients with these high-risk early-stage colorectal cancer tumors.
Alex Charlton, executive vice chairman of Everist Genomics, pointed out, “The human genome consists of roughly 25,000 genes. In order to develop a test capable of identifying these high-risk tumors, our task was to pinpoint the handful of genes and specific gene expression levels responsible for creating these tumors. Accomplishing this required analyzing and evaluating vast quantities of genomic information and potential combinations of genes.
The genomic culprits turned out to be a combination of five specific genes and gene expression levels. If they are present in a patient’s early-stage colorectal cancer tumor, then it’s a high-risk tumor.
Based on these insights, Everist Genomics has created the world’s only molecular diagnostic test, OncoDefender-CRC, capable of accurately identifying tumors at high risk for recurrence amongst all early-stage (Stage I/II) colon and rectal cancers. OncoDefender-CRC testing is provided as a CLIA lab-based service.
“The total cost of treating a patient after they have experienced a recurrence of their colorectal cancer is over $280,000," Charlton explained. “However, preventive chemotherapy costs the healthcare system about 20 percent of this amount. We believe that this combination of improved medical outcomes and reduced healthcare costs are key drivers for OncoDefender-CRC testing."
Everist Genomics made the OncoDefender-CRC test available commercially in November. During the first month of commercial availability, Everist Genomics has already fulfilled physician requests for over 1,000 OncoDefender specimen collection kits. Further supporting the clinical and financial merits of the test, Sanford Health Plan has established a reimbursement policy for OncoDefender-CRC, which will allow its members to receive coverage for the test beginning in January 2012.