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

SBIR 第一阶段：开发快速、现场护理诊断技术平台，以肝癌诊断为首个应用

• 批准号: 1621670
• 负责人: Johann deSa
• 金额: $ 22.5万
• 依托单位: Instadiagnostics Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1621670&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; Rapid; Point

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.

小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力在于个性化和预防性医学领域。拟议的工作旨在将目前以实验室为基础的血液/尿液/唾液检测带到护理地点，如初级/紧急/紧急护理设施、社区中心，以及一些疾病、养老院和自我检测。目前的标准结果时间从几天或几周不等，将减少到几分钟，允许在常规医生就诊期间进行疾病筛查，从而实现早期诊断和改善治疗监测。它将促进预防性护理，从而导致改善治疗结果、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、低功率、手持设备，可以在现场、低资源环境下、在美国和国际上操作，从而支持这些服务不足的社区改善健康管理。这项独特的技术有可能进一步提高目前的护理标准，通过可靠和可重复地在几分钟内从相同的几滴血液中检测出多种疾病。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各种疾病，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(主要是芯片实验室)，将整个基于实验室的诊断测试程序转换为快速和一次性的护理点式测试。挑战在于样本容量低(滴数很少)、样本类型复杂(未经处理的全血)、结果时间短以及对高准确度和可靠性的需求。为了满足这些严格的要求，一种基于无标签、超高频压电生物芯片、磁性纳米颗粒和微流体的独特组合的平台技术正在开发中。在这一第一阶段，将开发出阿尔法胎蛋白护理点检测所需的关键技术组件设计和规格，其性能可与当前的黄金标准集中式实验室方法，即酶联免疫吸附试验相媲美。在该第一阶段项目结束时，将制造和测试单个药筒组件的关键设计。这些部件将作为将在第二阶段执行的综合原型的关键输入，这将导致便携式护理点诊断设备。