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之前开发了基因组学IT和微阵列技术的组合，以非常低的成本批量生产中密度DNA微阵列。在这个SBIR提案中，我们将应用GUSA技术开发一种简单和低成本的方法，在这种中密度微阵列上执行复杂的hla分型。该SBIR的技术和业务重点是开发一种“HLA芯片”，以及相关的耗材和图像分析工具，以便在简单，便携式和现场就绪的环境中实现人群规模的HLA分型。在该提案的第一阶段，实现这一雄心勃勃的目标所需的技术套件将被改进并用于开发一种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位点，并作为beta现场测试进行验证，以每个便携式实验室站点每天1000人的速度记录准确的HLA基因分型。这个beta测试将通过简单的推断，证明只需10个低成本的便携式现场实验室就可以对大量暴露人群（每周10万人）进行HLA分型的能力。这样的HLA数据可以在HLA水平上“实时”用于预测个体被生物武器感染的风险或对同一感染因子接种疫苗的个性化反应。这种低成本、便携式HLA芯片技术的变体可以“衍生”出来，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身份识别，或用于灾难或法医应用中的民用身份识别。虽然直接由该SBIR应用中开发的技术实现，但那些其他民用和军事应用将在后续拨款申请中进行。

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.