FDA approves the first colorectal cancer blood test reagent

It is reported that the FDA approved the first colorectal cancer blood test reagent Epi proColon (Epigenomics).

According to the FDA Medical Device Advisory Committee, "Septin9 is highly methylated in colorectal cancer cells, but not in normal tissues. Epi proColon (Epigenomics) is a blood test for the methylation of the Septin9 gene. RT-PCR detects methylated Septin9 DNA in the blood and identifies patients at risk for colorectal cancer."

In fact, in 2014, Epigenomics submitted Epi proColon to the FDA for approval. However, there are great differences between the FDA advisory committees. The voting results supporting the test method with sufficient safety evidence are 9:0, with one abstention; The result of the vote for validity is 5:6; the result of the vote whose income exceeds the risk is 5:4, with one abstention. However, this test method has been approved in Europe and Argentina.

Dr. Karen Weck, director of the Laboratory of Molecular Genetics at the University of North Carolina at the time, said: "The proposed use of the test method is not clear. If it is a second-line option for people who are unwilling to perform immunohistochemistry test, it is not a substitute. Check. If I change the proposed use, I might vote for it."

Recently, the FDA-approved Epi proColon use is for the general risk group of colorectal cancer who is unwilling to undergo colonoscopy or fecal immunochemistry tests. EpipiCool (Epigenomics) can be used for simple blood tests. Before blood draw, diet and drugs. Not required, and can be done at a local or regional diagnostic laboratory.

Three clinical studies have shown the safety and efficacy of this agent, as well as potentially increasing the rate of screening for colorectal cancer. Epi proColon testing will be passed in the US Epigenomics and Polymedco joint commercial agreement, and Epigenomics will study the long-term benefits of the reagent.