Innovation Tools for the Molecular Diagnosis of Cancer

描述(申请人提供)：目前癌症患者的治疗依赖于使用临床和组织病理学数据的复杂组合来建立准确的诊断，但在某些情况下，由于非典型的临床或组织病理学数据，准确的诊断是困难的或不可能的。国家癌症研究所呼吁在研究和临床应用中为癌症诊断提供准确、实用和负担得起的工具。检测、鉴定和评估特定的mRNA在多个RNA样本中的表达模式正在成为癌症诊断的一项强有力的技术。 基因表达的分子检测可以提供系统的人类癌症信息，有助于对疾病的临床判断和适当的治疗。肿瘤基因表达特征的测量将使用书本大小的电子分析仪器和一次性96传感器阵列元素来完成。建议的表达分析系统将通过电活性酶标记进行与信号放大相连的灵敏和选择性的基因探针分析。预计的第一阶段结果将是通过实现验证测量的可测量里程碑(与实时聚合酶链式反应的一致性大于90%)来确定这项技术的可行性，该技术能够在电化学传感器板分析中使用高灵敏度的DNA传感器(里程碑10倍电流灵敏度60,000个分子)探测表达信号，从而在不到2小时的时间内对多个基因或多个样本进行分析。 Alderon Biosciences，Inc.是快速发展的分子检测系统领域的创新者，该公司拥有一支在电化学仪器和生物修饰传感器方面经验丰富的化学、生物化学、细胞培养和工程人员。该公司已成功筹集了数百万美元的非SBIR资金，用于产品开发、监管批准和商业化。这些经验已经产生了几种产品，包括FDA批准的体外诊断设备，旨在筛查儿童铅中毒。

DESCRIPTION (provided by applicant): Current treatment of cancer patients relies on establishing an accurate diagnosis using a complex combination of clinical and histopathological data but in some instances accurate diagnosis is difficult or impossible because of atypical clinical or histopathological data. The National Cancer Institute has called for accurate, practical, and affordable tools for the diagnosis of cancer in both research and clinical applications. The detection, identification, and evaluation of the expression pattern of a particular mRNA across many RNA samples are becoming a powerful technique for cancer diagnosis. Molecular assay of gene expression can offer systematic human cancer information useful to make clinical judgments regarding the disease and appropriate treatments. Measurement of tumor gene expression signatures will be done with a book-sized electro-analytical instrument and a disposable 96-sensor array element. The proposed expression analysis system will perform sensitive and selective gene probe assays linked to signal amplification via electroactive enzyme labels. The anticipated Phase I result will be establishing the feasibility of this technology by accomplishing the measurable milestones of validated measurements (greater than 90% agreement with real-time PCR), capable of probing expression signatures with highly sensitive DNA sensors (milestone 10x current sensitivity of 60,000 molecules) in Electrochemical Sensor Plate assays for multiple genes or multiple samples that take less than 2 hours. Alderon Biosciences, Inc. is an innovator in the rapidly developing field of molecular detection systems and the company maintains a chemistry, biochemistry, cell culture, and engineering staff experienced with electrochemical instruments and biologically modified sensors. The company has successfully raised several million dollars in non-SBIR funding for product development, regulatory approval, and commercialization. These experiences have yielded several products including an FDA-approved in vitro-diagnostic device designed to screen children for lead poisoning.