Population-scale HLA typing for home land defense

描述(申请人提供)：基因组学美国公司(GUSA)是一家专注于微阵列技术开发的生物技术初创公司。GUSA此前开发了基因组学、IT和微阵列技术的组合，以极低的成本大规模生产中等密度的DNA微阵列。在这个SBIR方案中，我们将应用GUSA技术来开发一种简单且低成本方法来在这样的中等密度微阵列上执行复杂的人类白细胞抗原配型。这个SBIR的技术和业务重点是开发一种“人类白细胞抗原芯片”，以及相关的消耗品和图像分析工具，以便在一个简单、便携和现场就绪的环境中实现人口规模的人类白细胞抗原分型。在这项提议的第一阶段，实现这一雄心勃勃的目标所需的一整套技术将得到改进，并用于开发一种将彻底分析人类人类白细胞抗原-B基因的人类白细胞抗原芯片。在第二阶段，开发过程将扩展到整个人类白细胞抗原基因座，并作为贝塔现场测试进行验证，以记录每个便携式实验室站点每天1000人的准确人类白细胞抗原基因分型。这项测试版测试将通过简单的外推，证明仅用10个低成本、便携的现场实验室就能对大量暴露人群(每周100,000人)进行人类白细胞抗原分型。然后，这种人类白细胞抗原数据可以“实时”地用于在人类白细胞抗原水平上预测个人被生物武器感染的风险，或对同一感染源接种疫苗的个性化反应。这种低成本、便携的人类白细胞抗原芯片技术的变种可以是“副产品”，用于第三世界环境中低成本、战地就绪的新生儿筛查，或用于战场就绪的个人身份识别，或用于灾难或法医应用中的民用身份识别应用。虽然这项SBIR应用程序直接采用了将要开发的技术，但这些其他民用和军用应用程序将在后续赠款申请中继续进行。

DESCRIPTION (provided by applicant): 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.