HHSN261201400049C; TOPIC 309 - DEVELOPMENT OF LOW COST, SMALL SAMPLE MULTI-ANALYTE TECHNOLOGIES FOR CANCER DIAGNOSIS, PROGNOSIS AND EARLY DETECTION; TITLE: LOW-VOLUME, ULTRA-SENSITIVE IMMUNODIAGNOSTIC

SBIR第二阶段项目的目标是开发一种低损失、超灵敏的免疫诊断系统， 用少量样品快速测定多种癌症生物标志物。第一阶段的努力得到证明 概念的可行性。第二阶段的工作重点是开发一种商业上可行的免疫诊断 系统和系统在多个测试站点的验证。 多标记物测定广泛用于癌症研究。目前的检测平台提供的选项有限： 快速的、可在低样品体积下工作的仪器通常是昂贵的并且具有有限的灵敏度。 超高灵敏度平台是昂贵的，并且通常需要复杂的样品制备步骤和大的样品体积。 卷Siloam开发了一种新型的“Optimiser”微流控分析平台，用于测量多种分析物 灵敏度为20倍，样品和试剂消耗量减少20倍，总检测时间少于20分钟。使用 该技术允许有限的自动化系统作为全自动免疫诊断分析仪操作， 克服了当前系统的成本和/或性能限制。 癌症是全球死亡的主要原因。预计2010年美国将有571，950人死于癌症 2011.免疫诊断系统可以帮助早期癌症检测和诊断， 死亡率/医疗负担。

The goal of this SBIR Phase II project is to develop a low lost, ultrasensitive immunodiagnostic system for measuring multiple cancer biomarkers rapidly with small amount of samples. Phase I efforts demonstrated convincing feasibility for the concept. Phase II efforts focus on developing a commercially viable immunodiagnostic system and validation of the system at multiple test sites. Multi-marker assays are widely used for cancer research. Current detection platforms offer limited options: instruments that are fast, can work with low sample volumes are typically expensive and have limited sensitivity. Ultra-high sensitivity platforms are expensive and typically require complex sample prep steps and large sample volumes. Siloam has developed a novel "Optimiser" microfluidic assay platform, for measuring multiple analytes with 20x sensitivity, 20x less sample and reagent consumption and total assay times less than 20 minutes. Use of this technology allows for limited automation system to operate as a fully automated immunodiagnostic analyzer, overcoming the cost and/or performance limitations of current systems. Cancer is the leading cause of deaths worldwide. 571,950 deaths from cancer were projected to occur in US in the 2011. The Immunodiagnostic system can help in early cancer detection and diagnosis and contribute to reduced mortality/healthcare burden.