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

这项小型企业创新研究（SBIR）二期项目旨在开发一种平台技术，用于检测体液中低浓度的疾病生物标志物。这项技术可以极大地影响目前的标准医疗工作流程，将获得结果的时间从几天或几周缩短到15分钟，允许在常规医生就诊期间进行疾病筛查，支持早期诊断和改进治疗监测。它将促进预防性护理，从而改善治疗结果，提高患者满意度，并降低医疗保健成本。这项技术将被整合到一种便携式低功率设备中，可以在美国和国际上的低资源环境中进行现场操作，从而支持更好的医疗保健监测，这在社会上服务不足的部分往往是缺失的。第一个目标应用是检测肝癌，这种疾病如果诊断较晚，死亡率极高，治疗费用也很高。该系统可能有助于肝癌的筛查和早期诊断。此外，由于技术？由于其固有的多路复用潜力，它有可能同时检测慢性肝病（乙肝、丙肝和肝硬化）的多种生物标志物，从而增加其对全球超过5亿患者的适用性。医学越来越注重个性化和预防性护理，因此对能够促进快速筛查、诊断和治疗监测的诊断工具的需求不断增加。目前市场上的大多数POC测试都是基于侧流的，并不针对癌症生物标志物等高灵敏度应用，这些应用需要定量结果，并且血液中的浓度很低。本二期项目的目标是开发一种独立的诊断系统，该系统由便携式读取器和一次性卡带组成，通过AFP的定量检测快速诊断肝细胞癌（HCC）。在第一年，将设计和制造一个20个传感器的甚高频（VHF）生物芯片，同时将开发和集成药筒的全血处理组件，形成一个全包药筒。分布式独立电子系统也将在第一年设计和测试。第二年将涉及到阅读器组件的集成，形成一个独立的系统，此外，全包的墨盒将修改接口与阅读器允许即插即用操作。综合系统的性能将通过检测注册样本中的HCC生物标志物并与当前的护理标准进行比较来评估。

This Small Business Innovation Research (SBIR) Phase II project aims to develop a platform technology for point of care (POC) detection of disease biomarkers present in low concentrations in bodily fluids. This technology can greatly impact the current standard medical workflow by reducing the time-to-results from days or weeks to 15 minutes, allowing for disease screenings during routine doctors visits supporting early diagnosis and improved treatment monitoring. It will promote preventative care, and therefore lead to improved treatment outcomes, patient satisfaction, and reduced healthcare costs. This technology will be incorporated into a portable, low-powered device that can be operated in-the-field, in low-resource settings in the US and internationally, supporting better healthcare monitoring that is often absent in under-served segments of society. The first target application is the detection of liver cancer, a disease that, when diagnosed late, has an extremely high mortality rate and cost of treatment. The proposed system may aid in the screening and early diagnosis of liver cancer. Furthermore, due to the technology?s inherent potential for multiplexing, it may be possible to simultaneous detect multiple biomarkers for chronic liver disease (Hep B, C, and cirrhosis), increasing its applicability to a global patient pool of over 500 million patients.Medicine is increasingly focused on personalized and preventative care and hence there is an increasing demand for diagnostic tools that can facilitate rapid screening, diagnosis, and treatment monitoring. Most current POC tests on the market are lateral flow based and do not target high sensitivity applications like cancer biomarkers, which require quantitative results and are present in low concentrations in blood. The goal of this Phase II project is to develop a standalone diagnostic system consisting of a portable reader and disposable cartridges to rapidly diagnose hepatocellular carcinoma (HCC) via the quantitative detection of AFP. During year 1, a 20-sensor very-high frequency (VHF) biochip will be designed and fabricated, simultaneously the whole blood processing component of the cartridge will be developed and integrated to form an all-inclusive cartridge. A distributed standalone electronic system will also designed and tested in year 1. Year 2 will involve the integration of the reader components to form a standalone system, additionally the all-inclusive cartridge will modified to interface with the reader allowing for plug and play operation. The performance of the integrated system will be evaluated via detection of HCC biomarkers in registry samples and comparison to the current standard of care.