Genomics USA, Inc. (GUSA) is a biotech start-up focused on microarray technology development. GUSA has previously developed a combination of genomics IT and microarray technology to enable the mass production of medium-density DNA microarrays at very low cost. In this SBIR proposal we will apply that GUSA technology to the development of a simple and low cost way to perform complex HLA-typing on such a medium density microarray. The technology & business focus of this SBIR is to develop an """"""""HLA Chip"""""""", plus associated consumables and image analysis tools to enable population-scale HLA-typing in a simple, portable & field-ready environment. In Phase I of this proposal, the suite of technologies required to achieve that ambitious goal will be refined and used to develop an HLA Chip which will thoroughly analyze the human HLA-B genotype. In Phase II, the development process will extended to the entire HLA loci and validated as a beta field test, to document accurate HLA genotyping at a rate of 1000 individuals per day per portable laboratories site. This beta test will demonstrate, via simple extrapolation, the ability to HLA type a large exposed population (100,000 individuals per week) by as few as 10 low cost, portable field laboratories. Such HLA data could then be used in """"""""real time"""""""" to anticipate, at the HLA level, individual risk of infection by a biological weapon or personalized response to vaccination against the same infectious agent. Variants of this low cost, portable HLA Chip technology could be """"""""spun-off"""""""" for low cost, field-ready neonatal screening in a third world environment or for battlefield-ready personal ID or for civilian ID applications in a disaster or forensic applications. Although directly enabled by the technology to be developed in this SBIR application, those other civilian & military applications will be pursued in follow-on grant applications.
