Epi proColon® has the potential to become an asset for many laboratories all over the country to join the fight on colorectal cancer. Epi proColon® is an in-vitro PCR (polymerase chain reaction) assay for the qualitative detection of Septin9 gene methylation in DNA isolated from the patient’s plasma. Cytosine residues of the Septin9 gene are methylated in colorectal cancer tissue but not in normal colon mucosa. This tumor-specific methylation pattern can be used to detect cell-free DNA shed into the blood stream by tumor cells. Detection of colorectal cancer-derived DNA in blood plasma using the Septin9 methylation biomarker has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of colorectal cancer.
Epi proColon® has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in Europe, China and selected other countries.
How is Epi proColon used for colorectal cancer screening?
Epi proColon® is indicated for colorectal cancer screening in average-risk patients. These patients choose not to undergo colorectal cancer screening by guideline-recommended methods such as colonoscopy and stool-based fecal immunochemical tests.
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.
Epi proColon® has received FDA approval. This has been based on demonstration of safety and efficacy after they have been established in three major clinical studies. The test has also demonstrated its potential to significantly increase participation rates in colorectal cancer screening. They will also initiate a post approval study to show the long-term benefit of blood-based colorectal cancer screening using Epi proColon®
What is Colorectal Cancer?
Colorectal cancer is the third most common type of cancer in men and women in the United States. It is cancer that starts in the colon or rectum. While digestion takes place, food moves through the stomach and small intestine into the colon. The job of the colon is to absorb water and nutrients from the food and stores the waste matter (feces). The feces then proceeds to the rectum from the colon before it leaves the body.
Most colorectal cancers are adenocarcinomas (cancers that begin in cells that make and release mucus and other fluids). Colorectal cancer often begins as a growth called a polyp, which can form on the inner wall of the rectum or colon. Over time they become cancerous. Removing these polyps can prevent colorectal cancer.
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Polymedco is the leading manufacturer, marketer and distributor of clinical diagnostic test kits. We are the world leaders in non-invasive colorectal cancer screening technology.