FDA approves the first colorectal cancer blood test reagent to detect Septin9 methylation

:2016-04-15

The manufacturer said 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."

For people at risk for colorectal cancer who are unwilling to undergo colonoscopy or fecal immunochemistry tests, choose Epi proColon (Epigenomics) for a simple blood test. There is no requirement for diet and medication before blood draw, and local or regional The diagnostic laboratory can do it.

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.

Original source:

FDA approves first blood test for colorectal cancer. Healio.April 13, 2016

Source: Metz Medicine

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