This Small Business Innovation Research (SBIR) Phase I project seeks to demonstrate the feasibility of a toolbox that is used to pretreat complex protein samples. Protein samples derived from serum, tissues, or cell lysates are enormously complex. They can contain hundreds of thousands of unique protein species that can vary in concentration by 10 orders of magnitude. The toolbox, comprising a general-purpose instrument, a cartridge and allied reagents, is intended to perform the majority of the sample pretreatment steps that are necessary to prepare it for separation and analysis. The toolbox operates on a novel physical principle that allows the sequential manipulation of the initial sample without labor intervention or the physical transfer of the protein solution from one operation to the next. Consequently, the protein sample that has been manipulated with the toolbox can be produced more reliably, with fewer losses, and with less likelihood of sample contamination. The broader impact/commercial potential of this project is to standardize reliable and rapid protein sample pretreatment. Proteomics is assuming a larger role in a variety of health-related fields, including drug discovery, lead optimization and toxicity testing, elucidating the mechanism of disease progression, and identification of diagnostic markers. In most of these pursuits, the potential power of proteomics is diluted by the complexity of protein samples. If proper pretreatment methods are used, the "unseen" proteome can be brought to light. This has the potential to increase the quality of proteomics data upon which these areas rely, and thereby offers the possibility to create new and improved therapeutics, diagnostics and understanding of disease. The business case is sufficiently compelling that, if the technology is demonstrated successfully, then a large and potentially lucrative market is available. In addition, there are other potential applications beyond proteomics that the underlying technology can address, which potentially opens the door to additional revenue streams
