The goal of the proposed SBIR Phase 2 program is to demonstrate a new magnetic detection platform technology in a next generation instrument that is capable of performing ultra-sensitive homogeneous assays for a wide range of analytes. The novel magnetic detection system will take advantage of major advances in high-temperature (high-Tc) SQUID sensors that enables the quantitative measurements of a small number of magnetic labels. We will develop a prototype instrument that is targeted at detection in the sub-attomolar range. While the sensitivity is a major strength, we will also focus on demonstrating a homogeneous format capability and an ability to work with small volumes of analyte, both of which are important for high throughput screening. We will perform head-to-head comparisons of magnetic immunoassays on cytokines with established detection techniques. We will additionally investigate the suitability of the instrumentation to the very important area of DNA probes. In theory, the sensitivity is so great that the potential exists to provide a simple and efficient alternative to PCR or other target amplifications systems. The commercial impact of this detection technology platform is enormous and ranges from high throughput screening for drug discovery to the clinical diagnostic DNA probe market.
Our goal is to develop a bench-top magnetic immunoassay detector to meet the needs of research and clinical laboratories where high sensitivity is required and existing techniques are limited by cost, throughput, sensitivity, or toxicity. While the initial instrument to be developed is targeted at a sizable research market, this new immunoassay system has potential to compete in many segments of the much larger ($5 billion/year world-wide) commercial clinical market. In addition the sensitivity of this technology may ultimately allow us to perform DNA analysis without performing a PCR amplification step and would find significant commercial and research application.
