ANN ARBOR, Mich., Dec. 6, 2011 /PRNewswire/ -- For decades, patients diagnosed with early-stage colorectal cancer believed they were relatively fortunate; that is, ‘the disease has been caught early; treatment with surgical removal of the tumor alone will suffice; I won’t need adjuvant chemotherapy; and my prospects for beating the disease are very good.’ This view was driven by the assumption that all early-stage colorectal cancer tumors were ‘low-risk’ for recurrence. However, recent studies have revealed that these assumptions were based on an incomplete understanding of early-stage colorectal cancer, namely, that some types of early-stage tumors are much more deadly than others.
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Recurrence and mortality rates associated with early-stage colorectal cancer are, in fact, 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% of those that do recur will die from their disease.
Dr. Peter Lenehan, Everist Genomics’ Chief Medical Officer, explains, “We now know that patients with ‘high-risk’ early-stage colorectal cancer are up to 29X 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% of patients identified with low-risk tumors experienced a recurrence of their cancers compared to a staggering 68% recurrence rate in patients with high-risk early-stage disease[1].”
This insight led the scientific team at Everist Genomics to study an important series of questions, explained Dr. Lenehan, “Could it be that previous research suggested that adjuvant chemotherapy had little impact on recurrence rates in early-stage colorectal cancer precisely because physicians were unable to distinguish early-stage low-risk tumors from high-risk tumors? 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? What would happen to survival rates in these patients? The answers to these questions were remarkable,” explained Dr. Lenehan.
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 3-year disease-free survival rates increasing from 84.7% in patients that did not receive chemotherapy to 96.4% in those that did. Improvements in 5-year overall survival rates increase from 86.4% to over 98%[2].
These insights led the scientists at Everist Genomics to commence a 2-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 points 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. Normally, an effort of this magnitude might require up to 10 years of research and analysis. Everist Genomics accomplished this in 2 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.”
The genomic culprits turned out to be a combination of 5 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.
In addition to helping physicians save lives, OncoDefender-CRC testing will help reduce the cost of cancer care[3]. “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.
About Everist Genomics
Everist Genomics is a prognostics company focused on developing gene-based molecular assays for the prediction of cancer recurrence and proprietary point-of-care equipment for the evaluation and management of cardiovascular disease. Using its patented Evolver technology platform, Everist Genomics is successfully developing and commercializing entirely new classes of patent-protected molecular biomarkers and sensor technologies which employ proprietary equipment, devices and software to help physicians make individualized treatment and drug prescribing decisions. The privately owned company is located in Ann Arbor, Michigan. For more information, please visit www.everistgenomics.com.
[1] T, Weinberg DS, Shultz S, et al. Occult tumor burden predicts disease recurrence in lymph node-negative colorectal cancer. Clin Cancer Res 2011 (doi:10.1158/1078-0432.CCR-10-3113)
[2] Source: Is adjuvant chemotherapy beneficial to high risk stage II colon cancer? Analysis in a single institute. Chun-Chi Lin & Jen-Kou Lin & Shih-Ching Chang & Huann-Sheng Wang & Shung-Haur Yang & Jeng-Kai Jiang &Wei-Shone Chen & Tzu-Chen Lin; Accepted: 8 January 2009 / Published online: 24 February 2009; Int J Colorectal Dis (2009) 24:665676
[3] National Institutes of Health
SOURCE Everist Genomics
