SBIR Phase I: Crosstalk-Free Multiplexed Immunoassay of Plasma Biomarkers

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)