SBIR Phase II: High multiplex visual mapping of heterogeneity in FFPE biospecimen

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This SBIR Phase II project aims to facilitate understanding of cellular diversity in tumors, a phenomenon that contributes to acquired drug resistance. Quantifying and understanding this diversity may help predict a patient?s response to certain drugs which would allow the selection of ideal drug combinations for an individual patient?s tumor, thus enabling personalized medicine. This Phase II project will provide drug developers and researchers with a tool that can quantify diversity by correlating genetic and spatial information from tumors, providing crucial information about tumor composition that is currently missing today. This project will translate the technology into an efficient, high-throughput workflow that will enable commercialization with drug developers, researchers, and reference laboratories, generating both income and multiple job opportunities. The commercialization of this innovation will significantly impact scientific, corporate, and patient communities. Researchers will have a new tool improving drug development for cancer and other diseases, including Alzheimer?s and diabetes. Payers, such as insurance companies and the government, will save costs by eliminating unnecessary spending on treatments for patients who will not respond. Most importantly, patients will have broader access to personalized medicine through new treatments and screening methods that can help determine the optimum drug combinations for them.A single tumor contains multiple populations of cells that each have unique mutations, and it is necessary to understand the location and genetic differences of these cells in order to provide effective combination therapies that will not result in overall treatment failure or relapse. This Phase II project aims to provide drug developers, researchers, and physicians with a tool to correlate genetic and spatial information about individual tumors. Using a proprietary microfluidic device adhered to a standard microscope slide and tissue biopsy, incorporated with a laser-coupled microscope, this tool is capable of providing information that it is not possible to obtain from any other method today. Building upon the feasibility established during the Phase I project, Phase II will involve performing NGS to demonstrate the instrument?s usefulness in providing data for clinical research and biomarker discovery. It will also involve building a fully integrated prototype instrument with features that increase automation and throughput to make the technology economically feasible for commercialization. These developments will showcase the instrument?s value to customers as well as enable the commercial launch of a service.