Colocalization-by-linkage assay on microparticles (CLAMP): A multiplex immunoassay platform for quantitative proteomics

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Proteins are the most commonly used biomarker analyzed in the clinic, and they are also measured for research and drug development. Today, the global immunoassay market for protein analysis is valued at $20B. For the past 50 years, the gold standard protein detection method has remained the sandwich immunoassay. A sandwich immunoassay uses a pair of antibodies, each highly specific for the target protein, to redundantly identify the protein within a sample. Whereas there is a desire and need to measure many proteins at once reliably and sensitively, it has proven very difficult to multiplex sandwich immunoassays. The underlying problem that prevents progress has long been known: to measure multiple proteins, multiple antibody reagents must be added and mixed together, but these reagents are "sticky" and cross-reactive. Hence, within these mixtures, antibodies cross-react with non-target proteins, or stick to one another, thus creating false positive binding signals and noise that cannot be untangled from the actual target protein-binding signal.** We have developed a sandwich immunoassay platform that overcomes cross-reactivity and sticking problems in multiplexed assays by preventing mixing of different antibody pairs in the first place. Hence, our technology can reliably and sensitively measure multiple proteins in a sample at once. In this I2I Phase 1 project, we propose to advance the platform from a proof-of-concept to a market-ready prototype. We propose to increase the number of proteins measured simultaneously to 50, and to test it by measuring proteins in the blood of cancer patients and healthy controls. Importantly, our approach is also user-friendly, fits within existing experimental workflows in biological and clinical research, and offers a low entry barrier by taking advantage of widely available instrumentation. These features and our results underline a significant commercial potential for the platform, and this I2I project will firmly establish the platform as a market-ready technology fit for investment and further commercialization. We expect our platform will open new avenues of proteomics research in academia and industry, create new jobs, and grow the Canadian immunoassay industry.