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Blood-based test for colorectal cancer screening

11th May 2016


The American Cancer Society projects there will be more than 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 US patients are not being regularly screened. While the 5-year survival rate for early colorectal cancer (stage I) is 90%, only four out of ten cases are diagnosed at this early stage. According to the American Cancer Society, this is in part due to the underuse of screening.

Now Epigenomics AG has announced that Laboratory Corporation of America Holdings is the first laboratory network in the US to offer Epi proColon, a blood-based test for colorectal cancer screening. Epi proColon® was recently approved by the U.S. Food and Drug Administration (FDA) and has been made available to laboratories in the United States under a joint commercialization agreement with Polymedco, Inc.

LabCorp is a leading healthcare diagnostics company, providing comprehensive clinical laboratory services through LabCorp Diagnostics and end-to-end drug development support through Covance Drug Development. LabCorp is a pioneer in commercialising new diagnostic technologies and is improving people’s health by delivering the combination of world-class diagnostics, drug development services and technology-enabled solutions.

“Colorectal cancer is one of the most curable diseases when detected in its early stages and treated surgically,” said Dr Mark Brecher, Chief Medical Officer for LabCorp Diagnostics. “Many people are not properly screened because they are reluctant to collect a stool sample or undergo a colonoscopy. Tested from a simple blood draw, Epi proColon is a convenient, accurate alternative for those patients who should be screened for colorectal cancer. LabCorp is committed to delivering world-class diagnostics, and Epi proColon will contribute to our mission to improve health and improve lives."

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).

Epi proColon has received FDA approval, based on demonstration of safety and efficacy as established in three major clinical studies. The test also demonstrated its potential to increase significantly participation rates in colorectal cancer screening.

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 tumour-specific methylation pattern can be used to detect cell-free DNA shed into the blood stream by tumour 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 US Food and Drug Administration (FDA) and is currently marketed in Europe, China and selected other countries.

 

 





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