I-Corps: Heat-stable binding proteins for diverse diagnostic applications

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The broader impact/commercial potential of this I-Corps project will be to enable the rapid development of novel diagnostic tests that are accurate, thermally stable, and affordable, thereby expanding access to medical care within underserved patient populations. Diagnostic immunoassays have traditionally relied upon binding proteins called antibodies for the capture and detection of biomarkers of disease in patient samples. The development and production of high-quality diagnostic antibodies is slow and expensive, and this class of reagents is frequently subject to thermal instability and off-target binding, resulting in inaccurate test results. This project focuses on the development of a novel class of low-cost, heat-stable binding proteins that can be rapidly developed and readily integrated into various diagnostic formats. These binding proteins can be engineered to target diverse disease biomarkers, making this platform suitable for the development of novel assays addressing many different medical conditions.This I-Corps project will explore the commercial potential of using binding proteins in a broad range of diagnostic applications. The proposed modular binding proteins have been validated for a range of standard diagnostic formats and numerous disease targets. The in vitro processes used to develop these new binding proteins can be finely controlled in order to ensure that selected reagents are highly target-specific, and bind to the biomarker of interest with high affinity. In addition, selected reagents can be subjected to further engineering in order to produce multi-functional protein constructs, enabling facile device manufacturing, high-gain signal amplification, and highly efficient target capture. Low-cost diagnostic devices incorporating these heat-stable reagents will enable the cost-efficient detection of disease cases at the point-of-care, and novel diagnostic capabilities enabled by this platform will address unmet public health needs.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.