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Circulating cell free methylated DNA (ccfm DNA) found in blood/serum, brochoalveolar lavage, saliva, sputum, and stools have shown to be a clinically valuable biomarker for screening and early diagnosis of cancers, especially when repeated tumor biopsies are not feasible. However, detection of circulating nucleic acid biomarkers is quite challenging since these biomarkers are present in very low quantify in body fluids. Currently used highly sensitive techniques such as multiplex PCR, quantitative real-time PCR (qRT-PCR), digital PCR are expensive, time consuming, labor intensive, require sophisticated and expensive instruments, highly trained laboratory personals, and are portable. We will develop an innovative low-cost technology platform for the rapid detection of methylated SEPT9, a clinically established blood biomarker for colorectal cancer. Using this technology platform we will be able to detect methylated SEPT9 present in blood/serum within 2-3 hours as opposed to currently used methodologies which require 18-20 hours. This novel technology platform for the rapid detection of methylated SEPT9 will be not only useful for screening and early detection of colorectal cancer but also can be utilized for developing novel methods for the diagnosis of other cancer types using cancer subtype specific circulating cell free or tumor specific methylated nucleic acid biomarkers.
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