SBIR Phase I: Development of a Rapid, Point-Of-Care, Diagnostic Technology Platform with the Diagnosis of Liver Cancer as the First Application

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力在于个性化和预防性医疗领域。拟议的工作旨在将目前基于实验室的血液/尿液/唾液测试带到护理点，例如初级/紧急/紧急护理设施，社区中心，以及某些疾病，退休之家和自我测试。目前的标准结果时间，从几天或几周不等，将减少到几分钟，允许在常规医生访问期间进行疾病筛查，从而实现早期诊断和改善治疗监测。它将促进预防性护理，从而改善治疗效果，提高患者满意度，并最终降低医疗成本。这项工作将导致开发一种便携式，低功耗，手持设备，可以在现场操作，在低资源环境中，在美国和国际上，从而支持改善这些服务不足的社区的健康管理。这项独特的技术有可能进一步提高目前的护理标准，在几分钟内从相同的几滴血中可靠地、可重复地检测多种疾病。虽然最初的目标是单一疾病肝癌，但未来几代人将针对从癌症到病毒和细菌感染的疾病，并可扩展到环境和兽医应用。拟议的项目旨在开发一种专有的多模式方法（本质上是芯片实验室），将整个基于实验室的诊断测试程序转化为快速和一次性的护理点测试。挑战在于低样本量可用性（几滴），复杂的样本类型（未处理的全血），短时间内获得结果以及需要高准确性和可靠性。为了满足这些严格的要求，正在开发一种基于无标签、极高频压电生物芯片、磁性纳米颗粒和微流体的独特组合的平台技术。在第一阶段，将开发关键技术组件设计和质量标准，用于即时检测甲胎蛋白，其性能与当前的金标准集中实验室方法（即ELISA）相当。在第一阶段项目结束时，将制造和测试各个药筒组件的关键设计。这些组件将作为第二阶段集成原型设计的关键输入，将产生便携式床旁诊断设备。

The broader impacts/commercial potential of this Small Business Innovation Research (SBIR) Phase I project lies in the area of personalized and preventative medicine. The proposed work is aimed at bringing current laboratory-based blood/urine/saliva-tests, to the point-of-care, such as primary/urgent/emergency care facilities, community centers, and for some diseases, retirement homes, and self-testing. Current standard time-to-results, ranging from days or weeks, will be reduced to a few minutes, allowing for disease screenings during routine physician visits resulting in early-diagnosis and improved treatment monitoring. It will promote preventative care, and therefore lead to improved treatment outcomes, patient satisfaction, and eventually reduced healthcare costs. This work will result in the development of a portable, low-powered, hand-held device that can be operated in-the-field, in low-resource settings, here in the US and internationally, thus supporting improved health management in these under-served communities. This unique technology has the potential to further improve the current standard of care by reliably and reproducibly detecting multiple diseases from the same few drops of blood in a few minutes. Although a single disease, liver cancer, is the initial target, future generations will target diseases ranging from cancers to viral and bacterial infections and can be expanded to environmental and veterinary applications.The proposed project aims to develop a proprietary multimodal approach (essentially lab-on-chip) that will translate the entire laboratory based diagnostic testing procedure to a rapid and disposable point of care test. The challenge lies in low sample volume availability (few drops), complex sample type (unprocessed whole-blood), short time-to-results and need for high accuracy and reliability. To address these stringent requirements, a platform technology based on a unique combination of label-free, very high frequency piezoelectric biochips, magnetic nanoparticles, and microfluidics is being developed. During this Phase I, key technology component designs and specifications that are required for the point-of-care detection of Alpha Fetoprotein with performance comparable to the current gold standard centralized laboratory method, i.e. ELISA, will be developed. At the end of this Phase I project, the critical designs of individual cartridge components will be fabricated and tested. These components will serve as critical inputs to the integrated prototyping to be performed in phase II that will result in a portable point of care diagnostic device.