SBIR-STTR Award

This SBIR Phase I project will address drug resistance in cancer patients through the advanced analysis of biopsies. Not only is each patient unique but their tumor contains a high level of genetic diversity as well. Overlooked diversity within patient tumors can lead to inadequate treatment and consequently acquired drug resistance, and has also been shown to predict therapeutic response to certain drugs. The proposed technology is capable of extracting and correlating tumor gene expression profiles to the spatial information and imaging of a biopsy so that a physical map of genetic diversity can be constructed. The initial application of this method will be in immuno-oncology where the spatial locations of immune cells fighting cancer have been shown to predict response to treatment. The next step will be to elucidate all cell types in the specimen that are usually overlooked with conventional diagnostics and use this information for determining treatment combinations that would affect all types of malignant cells found in this tumor. This directly addresses the Cancer Moonshot Initiative's focus on combination treatments for personalized medicine. Successful commercialization of this method will result in drug biomarker discovery services, precision screening for patients, and fundamental discoveries in biology by researchers using this tool to investigate various diseases. The technical innovation in this SBIR Phase I Project is the ability to correlate genomic analysis with spatial information to create an in-situ map of gene expression across the specimen. Imaging and big genomic data such as sequencing have been mutually exclusive, and the ability to correlate them in order to visualize genetic diversity within a specimen would be informative for both screening and research. The goals of this project are to demonstrate the ability to create a visual heat map of gene expression from archived biopsies and to show that this expression map identifies genetic diversity that standard analysis methods do not. Quantification of this diversity and the locations of deviations in the tumor will be the basis of future screenings for drug responsiveness as well as basic research into the causes and treatments of various diseases.

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.