IGF::OT::IGF R&D- MEDICAL: BIOMEDICAL (BASIC RESEARCH)

在血液/血清、支气管肺泡灌洗液、唾液、痰和粪便中发现的循环无细胞甲基化DNA（ccfm DNA）已显示为用于癌症筛查和早期诊断的临床上有价值的生物标志物，特别是当重复肿瘤活检不可行时。 然而，循环核酸生物标志物的检测是相当具有挑战性的，因为这些生物标志物在体液中以非常低的量存在。 目前使用的高灵敏度技术如多重PCR、定量实时PCR（qRT-PCR）、数字PCR昂贵、耗时、劳动密集，需要复杂且昂贵的仪器、训练有素的实验室人员，并且是便携式的。 我们将开发一种创新的低成本技术平台，用于快速检测甲基化SEPT 9，这是一种临床上确定的结直肠癌血液生物标志物。 使用该技术平台，我们将能够在2-3小时内检测血液/血清中存在的甲基化SEPT 9，而目前使用的方法需要18-20小时。 这种用于快速检测甲基化SEPT 9的新技术平台不仅可用于结肠直肠癌的筛查和早期检测，而且可用于开发使用癌症亚型特异性循环无细胞或肿瘤特异性甲基化核酸生物标志物诊断其他癌症类型的新方法。

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.