Epi proColon 2.0® is the first and only FDA-approved blood test colorectal cancer screening for people who are unwilling or unable to be screened by recommended methods. Neither pretest preparation nor stool handling is required fort he testing.
Epi proColon® is a molecular test that detects methylated Septin 9 DNA in blood. DNA methylation of the SEPT9 gene is increased in colorectal cancer. lMethylated Septin 9 tumor DNA is shed into the bloodstream and displays a unique methylation pattern that is detectable in plasma by Real-Time PCR.
Epi proColon 2.0® can detect DNA in picogram level and can give result of genetic material of tumor.
Test results are reported as qualitative, either positive or negative. For precision studies, plasma pools were used to accommodate the sample volume required to analyze samples in multiple runs of three PCR replicates per sample. The result of 2/3 or 3/3 tests indicate the final result.
The negative result highly exclude the CRC incidance. However patient is advised to repeat testing regulary every one or two years.
The positive result shows the presence of methylated septin9 gene in the blood. This does not shows that patient definitively has CRC, but the posibility having colorectal cancer is 11.9-28.9% according to PPV result. In other words 1/3 of patients having positive result will have cancer. It should be remembered that this is a screening test and colonoscopic examination should be done to observe the anamoty and histopathological specimen must be taken form any possible lession. <
Positive results have been observed in healthy patients and clinically diagnosed patients with chronic gastritis, lung cancer and in pregnant women. EpiproColon® 2.0 test result should be evaluated with his physicain with all of his medical history and examination findings.