SBIR-STTR Award

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.

Thesaurus Terms:
histocompatibility typing, mass screening, microarray technology, technology /technique development MHC class I antigen, bioinformatics, bioterrorism /chemical warfare, communicable disease, computer program /software, consumable /disposable biomedical equipment, disease /disorder proneness /risk, genotype, immune response, molecular probe, portable biomedical equipment, vaccine evaluation bioengineering /biomedical engineering, clinical research, human genetic material tag

Current technology for HLA typing does not have rapid field response capability because it too expensive and is too complicated to be implemented in the context of a population-scale emergency. The ultimate goal of this proposal is to develop a simple, accurate, low cost method to perform complex HLA typing through development of an "HLA Chip" which will enable population-scale analysis of a large set of the most important HLA alleles. Genomics USA (GUSA) has developed a unique "self-assembling" microarray technology and bioinformatics to enable the mass production of medium density microarrays at very low cost. In Phase I of this SBIR, the following major objectives were accomplished: 1) An enabling variant of the original self-assembling GUSA microarray platform was discovered which allows high sequence specificity and a 10-fold increase in hybridization signal relative to the technology described in the original application. The observed result of this major improvement is direct, biochemically-unaided SNP detection with the simplicity, accuracy and reproducibility required for low cost, population scale HLA typing. 2) Bioinformatics tools were developed to create large sets of SNP- selective hybridization probes that are consistent with the physical requirements imposed by "self- assembling" attachment of probes to the microarray surface and 3) It was demonstrated that a buccal swab is an excellent source of DNA for miniaturized HLA typing on the HLA Chip and a simple approach to collect buccal swabs in the field and to store them for centralized HLA processing in the dry state was also developed. In Phase II of this SBIR, the HLA Chip development process will be extended to the entire HLA locus and validated as a beta field test to document accurate HLA genotyping at a rate of 1000 individuals per day per portable laboratory site. The beta test will demonstrate, via, simple extrapolation, the ability to HLA type a large exposed population (100,000 individuals per week) using 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 a variety of other applications: civilian ID in a disaster or personalized medicine, especially for autoimmune diseases. Those other applications are technically similar, but will be explored and funded independently. The project focus is the development of a low-cost population-scale HLA Chip technology that can be implemented in a rapid-response environment that would allow rapid HLA typing of a large exposed population (100,000 individuals per week) in order to identify high risk individuals and to predict, on an individual level, their personalized response to vaccination.

Thesaurus Terms:
There Are No Thesaurus Terms On File For This Project.