SBIR Topic 238 - Development of Clinical Automated Multiplex Affinity Capture Te

预计2006年将有200多万新的癌症病例。早期诊断以改善预后的必要性已得到充分证明。研究表明，在临床环境中，单分子标记物不能准确地诊断个体。常见的蛋白质发现技术缺乏在一次分析中定量测量多种生物标志物的能力，而较新的技术则缺乏灵敏度、精度和自动化。基于规则的医学（RBM）已经开发出基于头部的多重免疫测定法，用于执行生物标志物的多分析物谱（MAPs），解决了这些局限性。因此，该项目的目标是开发定量、自动化、50-plexed免疫分析法，用于快速检测低丰度癌症相关蛋白。为了进一步增加该平台上内容的广度，需要开发和筛选数百到数千个配体结合分子的新方法。因此，该项目的第二个目标是提供一种创新的方法，用于快速筛选多种配体结合分子，以确定那些提供最佳MAP性能的分子。如果成功，该计划的两个目标都将作为服务于制药、生物技术、医学和基础研究界的商业应用。

Over 2 million new cancer cases are expected in 2006. The need for early diagnostics that improve prognosis is well documented. Studies have shown that single molecular markers are not able to accurately diagnose individuals in the clinical setting. Common protein discovery technologies lack the ability to quantitatively measure multiple biomarkers in a single assay, while newer technologies suffer from a lack of sensitivity, precision and automation. Rules-Based Medicine (RBM) has developed bead-based multiplex immunoassays for performing Multi-Analyte Profiles (MAPs) of biomarkers that has addressed these limitations. Thus, a goal of this program is to develop quantitative, automated, 50-plexed immunoassay for the rapid detection of low abundance cancer-related proteins. To further increase the breadth of the content on this platform, new methods to both develop and screen hundreds to thousands of ligand binding molecules are needed. Thus, the second goal of the program is to deliver an innovative approach for the rapid screening of multiple ligand binding molecules to identify those providing optimal MAP performance. If successful, both goals of this program have commercial application as a service to pharmaceutical, biotechnological, medical and basic research communities.