Most microfluidic point-of-care (POC) analysis devices have been fabricated using silicon (Si), glass and polymer as substrates for the microfluidic substrate. Plastic substrates, such as polycarbonate (PC), polyethylene terephthalate (PET), poly(dimethylsiloxane) (PDMS), polyimide, polymethamethylacrylate (PMMA), offer a wide range of biocompatible property parameters for biochemical or medical applications at low cost using conventional molding process. The wide variety of biocompatible surface properties of commercially available polymer/plastics provides a critical competitive advantage over conventional silicon or glass-based manufacturing method for the POC application. Currently, commercially available POC devices such as glucose meters or i-STAT blood chemistry assays do not provide microbiological diagnosis at the point of care, preventing rapid response to potential threats presented by bioterrorism and emerging infectious diseases. There is a significant amount of interest in POC device development among both academic and industrial research but the high initial capital investment and long development cycle significantly reduce the actual development effort. A rapid, inexpensive, POC test capable of adapting existing assay protocols with a high degree of accuracy would be a major advance. In addition, rather than building a POC system from scratch, a ready-to-use POC platform would accelerate development efforts to impede the rapid emergence of wide spread diseases. The overall goal of this SBIR Phase I application is to develop and validate the prototyping fabrication process of a universal point-of-care (POC) system that is capable of adapting existing assay protocols for life science research and clinical diagnostics. We propose to establish a design library of standard molecular analysis assays and make the POC prototyping service available for every researcher to address the high priority initiatives of NIH and CDC. We will start with a cartridge design that could perform 10 multiplexed assays (genetic assays and/or immunoassays) in Phase I and expand to more common assay protocols to enable cartridges for optimization, large scale production and clinical study of the POC system in Phase II. With an optimized cartridge design through the POC cartridge prototyping fabrication, large scale manufacturing of the cartridges can be done by injection molding after the analytical validation on the prototyping cartridges via the proposed rapid fabrication method. In this proposed 6-month Phase I study, we will establish a design library for POC cartridge prototyping and fabricate 10 assay-specific integrated cartridges (ASICs) from design order to shipment ready in 6 hours. The cost of good sold (COGS) of the prototype cartridge will be less than $20 for 10 assays in Phase 1. The COGS of the POC control system will be less than $5k.
In this proposal, we will leverage our ongoing Cooperative Agreements (NIDCR U01 DE017790 and U01 AI082457) for the development of point-of-care (POC) diagnostic cartridges for multiplexed cancer marker screening and rapid pathogen identification. Based upon the experience and knowledge gained by developing and producing these cartridges for our ongoing Cooperative Agreements, this proposed Phase I study will establish a design library to accommodate the most common molecular analysis assays including genetic testing, immunoassay and electrolyte detection. After the successful completion of Phase I, we will make the standard cartridge design modules commercially available and provide the rapid POC cartridge prototype fabrication service to any research institutions interested in exploring POC applications. With the prototype fabrication service, the high initial capital investment and long development cycle, which are often required for POC system development, will no longer be a road block to the scientific development and commercialization efforts for POC methiods. Using a multiplexed pathogen identification cartridge capable of both protein and RNA detection as a model, we will demonstrate a universal POC molecular analysis system that can be rapidly adapted by end users using existing protocols and reagents for hands-free POC field tests in one week. The system will have an enormous favorable impact in the field of molecular analysis research and development in nontraditional settings. Researchers can have their own customized version of a POC system without the development risk and capital investment to accelerate the advancement in Point-of- Care testing.