Epigenomics AG, the German-American cancer molecular diagnostics company, announced that the U.S. FDA has approved the its lead product, Epi proColon®, the first and only FDA-approved blood-based colorectal cancer screening test. Epi proColon® will be made available in the United States under a joint commercialization agreement with the Company’s strategic partner Polymedco, a leader in non-invasive colorectal cancer screening technology.
Epi proColon® is indicated for colorectal cancer screening in average-risk patients who choose not to undergo colorectal cancer screening by guideline-recommended methods such as colonoscopy and stool-based fecal immunochemical tests (FIT). For patients, the test only requires a simple blood sample to be drawn as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a local or regional diagnostic laboratory.
According to the American Cancer Society, there are projected to be over 134,000 new diagnosed cases of colorectal cancer and almost 50,000 deaths from colorectal cancer in 2016 in the United States. Colorectal cancer remains the second-leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, about 35 percent of eligible U.S. patients are not being regularly screened.