Population-scale HLA typing for home land defense

描述（由申请人提供）：Genomics USA，Inc.（GUSA）是一家专注于微阵列技术开发的生物技术初创公司。GUSA之前已经开发了基因组学IT和微阵列技术的组合，能够以非常低的成本大规模生产中等密度的DNA微阵列。在SBIR的建议中，我们将应用GUSA技术来开发一种简单且低成本的方法来在这种中等密度的微阵列上进行复杂的HLA分型。该SBIR的技术和业务重点是开发一种“HLA芯片”，加上相关的耗材和图像分析工具，以便在简单，便携和现场就绪的环境中实现人群规模的HLA分型。在该计划的第一阶段，实现这一宏伟目标所需的一套技术将得到完善，并用于开发一种HLA芯片，该芯片将彻底分析人类HLA-B基因型。在第二阶段，开发过程将扩展到整个HLA基因座，并作为β现场测试进行验证，以记录每个便携式实验室每天1000人的准确HLA基因分型。通过简单的外推法，这一β测试将证明，只需10个低成本、便携式现场实验室就能对大量接触人群（每周10万人）进行HLA分型。然后，可以“真实的”使用此类HLA数据来在HLA水平上预测生物武器感染的个体风险或对针对相同传染性病原体的疫苗接种的个性化反应。这种低成本、便携式HLA芯片技术的变体可以被“分离”，用于第三世界环境中的低成本、现场就绪的新生儿筛查，或用于战场就绪的个人ID，或用于灾难或法医应用中的民用ID应用。虽然直接启用的技术将在此SBIR应用程序中开发，这些其他民用和军用应用程序将在后续的赠款申请。

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.