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

有效的癌症管理依赖于早期诊断、准确的肿瘤分期和持续的监测。然而，目前的许多诊断程序都是侵入性的、昂贵的和令人不快的。在最近发表的多项研究中，循环中无细胞DNA(CfDNA)的浓度和完整性(片段化模式)已显示出作为多种癌症类型的高度敏感和特异的、微创的血液生物标志物的前景。InnoGentics拥有一项专利程序，能够在高度敏感的多重qPCR反应中同时检测这一应用中最常用的遗传靶点，即不同大小的高拷贝数反转录转座元件，并包括内部阳性对照，以监测血清或血浆中潜在存在的聚合酶链式反应抑制物。这个SBIR第一阶段的项目将专注于开发和评估一种基于逆转座子元件的多重定量聚合酶链式反应方法的可行性，以强有力地定量和区分结直肠癌患者和对照组血浆和血清中cfDNA的完整性和浓度。这种分析将提供一种准确、微创、快速、高通量和成本效益高的方法，有可能补充或取代现有的CRC检测、诊断、预后、治疗监测和/或监测程序，从而改善CRC患者的预后。

Effective cancer management depends on early diagnosis, accurate tumor staging, and consistent monitoring. However, many current diagnostic procedures are invasive, expensive and unpleasant. In multiple recent published studies, circulating cell-free DNA (cfDNA) concentration and integrity (fragmentation pattern) has shown promise as a highly sensitive and specific, minimally invasive blood biomarker for multiple cancer types. InnoGenomics has a proprietary process enabling the most commonly employed genetic targets for this application, high copy number retrotransposable elements of varying sizes, to be simultaneously assayed in a highly sensitive multiplex qPCR reaction, with the inclusion of an internal positive control to monitor the presence of PCR inhibitors potentially present in blood serum or plasma. This SBIR Phase I project will focus on developing and evaluating the feasibility of a retrotransposable element based multiplexed qPCR assay to robustly quantitate and distinguish cfDNA integrity and concentration in blood plasma and serum from colorectal cancer (CRC) patients and control subjects. Such an assay will provide an accurate, minimally-invasive, rapid, high-throughput, and cost-effective method with the potential to complement or replace existing procedures for CRC detection, diagnosis, prognosis, treatment monitoring and/or surveillance, thereby improving CRC patient outcomes.