The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be to develop new tools for rapid and customized protein testing. The proposed technology would allow the end user to rapidly pattern their own high-throughput arrays, reducing assay time from days or weeks to minutes. In addition, the proposed 3D hydrogel reaction environment is expected to improve binding interactions and sensitivity compared with the current surface immobilized substrates, such as protein microarrays, ELISA, and bead-based systems. Today, the protein microarray market is dominated by companies selling pre-patterned arrays, and labs providing costly customized array services. The proposed technology will have the potential to transform and advance the widespread adoption of protein microarray measurements into broader life science research applications ranging from high-throughput pharmaceutical research and antibody development to customized personalized medicine. In addition, this transformational technology promises to improve customization and speed while driving down costs, making high accuracy protein testing routine and accessible within the $782M research and diagnostics market.
This SBIR project aims to develop a rapid and multiplexed protein testing platform to be easily customized and run by third-party users. Current protein microarrays can analyze targets from a single sample against hundreds of surface-immobilized capture molecules. However, problems preventing widespread adoption of traditional protein microarrays include high costs, long assay times, or a lack of customization, sample multiplexing, and specificity. The proposed Electrokinetic Gel Microarray (EGM) technology will surpass these barriers through core advances in functionalized hydrogels integrated within microfluidic architectures that could allow a user to pattern and test tens to hundreds of user-customized analytes on a postage stamp-sized chip. The Phase I goal is to design and test key EGM technology that proves feasibility of developing a customizable 15 minute protein-ligand array on a microdevice with a 3D hydrogel architecture. These functionalized gels will allow for efficient homogeneous protein interactions while significantly enhancing the binding environment over traditional heterogeneous surface-immobilized arrays. Phase I tasks will include developing a gel-based protein capture system, optimizing assay and optical readout protocols, validating quantitative measurement of a model protein system, and designing the assay microfluidic chips.
Utilizing this Phase I SBIR grant, Correlia Biosystems Inc. has demonstrated the feasibility of a novel Electrokinetic Gel Microarray (EGM) technology that is developed from core advances in functionalized hydrogels within microfluidic architectures. With further development built upon the phase I efforts, Correlia’s rapid protein testing platform will disruptively advance the current microarray technology by; reducing the time to complete hours long protein assays to the order of 10-20 minutes; increasing the sample multiplexing; and enabling further automation. The proposed life science research tool will have a broad impact in advancing and speeding up the proteomic research activities in academia and pharmaceutical industry such that novel health care products will become available to the public faster and more cost effectively. Correlia Biosystems has successfully completed all of the tasks proposed in the grant application. Utilizing the funds provided by this grant, Correlia Biosystems Inc. demonstrated an automatable gel fabrication, patterning and assay method. The assay was realized utilizing model proteins and antibodies that are most widely used in pharmaceutical industry. In terms of the proposed tasks, the first accomplishment was the optimization of appropriate gel fabrication and analyte patterning parameters for a highly multiplexed system which would provide high yield and repeatable results. Next, we have formulized and optimized the assay protocol steps -such as analyte loading and washing- such that we have proven hours long assay steps can be completed on the order of a few minutes without compromising sensitivity or quantification. The third important accomplishment was the defining and standardization of quantitative assay readout and measurement parameters. We have shown that the utilized detection method enables a higher dynamic range compared to gold-standard commercial assay platforms available in the market. Fourthly, we have proven the performance of EGM technology by performing lower limit of detection, sensitivity and specificity assessments for model antibody protein pairs. Finally, in the light of our accomplishments we have completed the design of a second generation microfluidic chip geometry which will enable further utilization of new results achieved during the execution of this project.
