Everist Genomics Discovers Genes Responsible for Recurrence of Colorectal Cancer

ANN ARBOR -- The pharma startup Everist Genomics said Tuesday it had identified five specific genes and gene expression levels that lead to recurrence of colorectal cancer -- even when the cancer is caught at an early stage and surgically removed.

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 Stage I and II colon and rectal cancers. OncoDefender-CRC testing is provided as a lab-based service.

The insight is important, because for decades, patients diagnosed with early-stage colorectal cancer believed they were relatively fortunate -- they had caught the cancer earlier and surgical removal of the tumor would be all that was required, and they could avoid chemotherapy.

But recent studies have shown that recurrence and mortality rates associated with early-stage colorectal cancer are much higher than previously realized. Nearly one in three patients with Stage 2 colon cancer that have undergone surgical removal of their tumor alone will have a recurrence of their cancer, and over 80 percent of those that do recur will die from their disease.

Said Peter Lenehan, chief medical officer of Everist Genomics, said: "We now know that patients with 'high-risk' early-stage colorectal cancer are up to 29 times more likely to have a recurrence of their tumors than patients with low-risk disease.  More specifically, in a recently completed study involving 291 colorectal cancer patients, fewer than 3 percent of patients identified with low-risk tumors experienced a recurrence of their cancers compared to a staggering 68 percent recurrence rate in patients with high-risk early-stage disease."

The scientific team at Everist Genomics identified research which revealed that patients with high-risk Stage 2 colorectal tumors can benefit greatly from chemotherapy, with 3-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 5-year overall survival rates increase from 86.4 percent to over 98 percent.

Explains Alex Charlton, executive vice chairman of Everist Genomics: "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. Normally, an effort of this magnitude might require up to 10 years of research and analysis. Everist Genomics accomplished this in two years by integrating the company's deep expertise of genomics and molecular diagnostics with their proprietary learning algorithm, Evolver,  a powerful computer based algorithm which analyzed and evaluated possible combinations of genes and gene expression levels to identify the ones we were looking for."

In addition to helping physicians save lives, OncoDefender-CRC testing will help reduce the cost of cancer care.

"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% of this amount.  We believe that this combination of improved medical outcomes and reduced health care 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.

More at www.everistgenomics.com.