SBIR-STTR Award

This Small Business Innovation Research (SBIR) Phase I project fills a key technological gap in development of biological and chemical sensor development. There is an unmet need for tests that easily detect molecular, cellular, or clinical responses that indicate disease onset or predict which candidate drugs will have harmful side effects. In this project, we are addressing this need by innovating and commercializing a reliable, sensitive, and accurate test that simultaneously monitors and quantifies levels of multiple proteins in biological fluids (plasma, urine, serum). These target protein biomarkers indicate disease onset, disease progression, or drug efficacy. The test is simple and can be performed using existing laboratory equipment, allowing for easy adoption in academic labs and pharmaceutical companies. Furthermore, this test is the only test that reliably prevents false positive signals, which typically result from nonspecific binding between non-target protein-detection agents. Preventing false positive signals is crucial because it enables more accurate measure of proteins in biological fluids. An initial test panel of proteins to be tested will be for cardiovascular disease management and drug development.

The broader impact/commercial application of this project is in the $1 billion life science research market that today is served mainly by tests that can only detect a single protein at a time. Measuring proteins one by one is time- and labor-intensive. The proposed research has tremendous potential as a research tool for highly accurate detection and analyses of protein biomarkers, leading to better understanding of disease pathogenesis and therapeutic response. The innovative, new test also has potential applications in the $36.6 billion contract research organization market to improve drug safety and efficacy testing, decrease clinical trial costs, and decrease time to market. This proposal advances the fields of Biological and Chemical Technologies (BC) as well as of Nanotechnology, Advanced Materials, and Manufacturing (NM)

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is in the $1 billion life science research market that is served mainly by multiplex protein tests. The research proposed here has tremendous potential as a tool for highly accurate and robust detection of proteins that have been linked to cardiovascular disease. Additionally, the development of this core technology can be used for research of numerous other diseases. The product developed during this project has potential applications in the pharmaceutical and contract research organization markets for drug discovery, monitoring therapeutic efficacy, and assisting with clinical studies. While this Phase II proposal includes the development and commercialization of a DVT panel, the commercial product offering will cover a wider variety of disease-related proteins for research applications (e.g. protein combinations in which academic researchers, contract research organizations, or pharmaceutical companies have interest).The proposed project will result in a better, more robust tool for detection of disease-related proteins in patient blood. The product will be able to measure the amounts of multiple proteins at one time without a problem known as ?antibody crosstalk?, which hinders the quality of results when using other technologies. Work on this project will involve developing a kit that includes equipment and reagents for an end-user to work with and analyze blood samples for proteins of interest, in this case those involved with cardiovascular disease. A working prototype device was developed as part of Phase I funding, and Phase II will improve upon the device (increased analysis time and multiplexing) until useful for the analysis of clinical samples. Patient samples, already collected, banked, and de-identified under IRB approval, will be analyzed in a collaborative effort with researchers at the University of Michigan. Results from Phase II support will include a useful multiplexed protein biomarker immunoassay platform that has been validated using patient blood samples.