SBIR Phase I: Reel-to-Reel Assembly of Lab-on-a-Film Diagnostic Tests

This Small Business Innovation Research (SBIR) Phase I project is designed to investigate the feasibility of manufacturing a lab-on-a-film microarray device on a reel-to-reel assembly line. Reel-to-reel manufacturing has the potential to drastically reduce device cost because hundreds of parts per hour can be assembled. The objectives of this project are two-fold: (1) investigate the feasibility of using materials and films that can be rolled, so as to determine the possibility of manufacturing a lab-on-a-film microarray device, and (2) develop a valveless PCR-microarray device in a lab-on-a-film format such that a PCR amplicon is confined to the device. The first objective requires (1) printing microarrays with Akonni?s gel drop technology on chemically-unmodified thin films with low autofluorescence, and (2) identifying tapes and films that can be rolled (i.e., conducive to reel-to-reel manufacturing) to create the lab-on-a-film assembly. The second objective of designing a valveless lab-on-a-film device also is important to transfer the design to a reel-to-reel manufacturing process because the steps associated with adding components for a valve are eliminated. At the conclusion of this project, we expect to demonstrate feasibility by positively identifying MRSA on a PCR-microarray lab-on-a-film device. The broader impact/commercial potential of this project is an ability to distribute quality diagnostics to an expanded population. With cost being such an important factor in today's healthcare system, there is a need to investigate new avenues for offering quality diagnostics arises with increasing urgency. This challenge may become a catalyst for a new multiplexing paradigm in molecular diagnostics. Whereas, for this project, we apply lab-on-a-film manufacturing to MRSA, a range of possibilities also emerge such as infectious disease testing for multiple organisms, pathogenic genotyping, genetic testing, forensics, environmental screening, agriculture testing, and biodefense applications. Addressing not only the usability of the end test but also the manufacturing process, is a means to be competitive in a $50 billion global diagnostics market space.