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

SBIR 主题 238 - 临床自动多重亲和捕获技术的开发

• 批准号: 7824149
• 负责人: JAMES MAPES
• 金额: $ 25.05万
• 依托单位: RULES-BASED MEDICINE, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-28 至 2010-03-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7824149
• 关键词: SBIR; Topic; 238; Development; Clinical

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. In Phase I, a quantitative, automated, 5-plex immunoassay for the rapid detection of low abundance cancer-related proteins will be developed. 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, in Phase I, an innovative approach for the rapid screening of multiple ligand binding molecules to identify those providing optimal MAP performance will be developed. During Phase II, we propose to validate the screening platform developed in Phase I by screening ligand binding molecules for an additional forty-five targets. In doing this, a 50-plex immunoassay for low abundance cancer-related proteins (i.e., an Oncology MAP) will be developed. If successful, both the screening platform and the 50-plex Oncology MAP will have commercial application as a service to pharmaceutical, biotechnological, medical and basic research communities.

预计2006年将有200多万新的癌症病例。需要早期诊断，改善预后是有据可查的。研究表明，单一的分子标记物不能准确地诊断临床上的个体。常见的蛋白质发现技术缺乏在单一测定中定量测量多种生物标志物的能力，而较新的技术缺乏灵敏度、精确度和自动化。基于规则的医学（RBM）已经开发了基于珠的多重免疫测定，用于执行生物标志物的多分析物谱（MAP），解决了这些限制。在第一阶段，将开发用于快速检测低丰度癌症相关蛋白的定量、自动化、5重免疫测定。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至数千种配体结合分子的新方法。因此，在I期，将开发用于快速筛选多个配体结合分子以鉴定提供最佳MAP性能的那些配体结合分子的创新方法。在第二阶段，我们建议通过筛选另外45个靶点的配体结合分子来验证在第一阶段开发的筛选平台。在此过程中，低丰度癌症相关蛋白质的50重免疫测定（即，肿瘤MAP）。如果成功的话，筛查平台和50路肿瘤MAP都将作为一项服务于制药、生物技术、医学和基础研究社区的商业应用。