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

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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.