Fecal DNA Testing for Colorectal cancer Screening

描述（由申请人提供）：这是SBIR项目的一期申请，将致力于开发一种用于CRC筛查的新的粪便DNA测试，该测试将利用我们在初步研究中发现的新的三标记面板。结直肠癌是美国第二致命的癌症。好消息是，早期发现和切除与近100%的五年生存率相关。粪便DNA检测正在成为取代粪便潜血检测用于CRC筛查的最有前途的方法之一。最近，我们发现了一组新的粪便DNA标记，可以检测出86%的CRC，特异性为82%。由于这种新的面板不包含甲基化的DNA标记，因此将其用于CRC筛查的一大好处是用于提取DNA的粪便数量可以减少至少10倍，从而大大降低了粪便DNA检测的复杂性和成本。据我们所知，这可能是最简单的一组标记，可以达到如此高的检测灵敏度和良好的特异性。这个一期项目的具体目的是验证这种用于CRC筛查的新的标记面板。验证将使用训练-测试集程序进行。第一阶段的里程碑是证明新的标记面板可以检测~85%的CRC，特异性为~80%。

DESCRIPTION (provided by applicant): This is the Phase I application of a SBIR project that will be devoted to develop a new fecal DNA test for CRC screening, which will utilize a new tri-marker panel discovered in our preliminary study. CRC is the second deadliest cancer in USA. The good news is that early detection along with resection is associated with a five-year survival rate of nearly 100%. Fecal DNA testing is emerging as one of the most promising methods to replace fecal occult blood tests for CRC screening. Recently, we discovered a new panel of stool DNA markers that could detect 86% of CRC with a specificity of 82%. Because this new panel contains no methylated DNA markers, a great benefit of using it for CRC screening is that the quantity of the stool used to extract DNA could be reduced by at least 10 fold, greatly reducing the complexity and cost of fecal DNA testing. To the best of our knowledge, this may be the simplest panel of markers that can achieve such high detection sensitivity with good specificity. The specific aim of this Phase I project is to validate this new marker panel for CRC screening. The validation will be carried out using the training-test set procedure. The milestone set for Phase I is to demonstrate that the new marker panel can detect ~85% of CRC with a specificity of ~80%.