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

该小型企业创新研究（SBIR）第二阶段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，将结果的时间从几天或几周缩短到15分钟，允许在常规医生访问期间进行疾病筛查，支持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，降低医疗成本。这项技术将被整合到一个便携式、低功耗的设备中，该设备可以在美国和国际上的低资源环境中现场操作，支持更好的医疗监测，而这在社会服务不足的地区往往是不存在的。第一个目标应用是肝癌的检测，这种疾病在晚期诊断时具有极高的死亡率和治疗成本。该系统可以帮助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，可以同时检测慢性肝病（Hep B、C和肝硬化）的多种生物标志物，从而增加其对超过5亿患者的全球患者库的适用性。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在血液中以低浓度存在。该II期项目的目标是开发一种独立的诊断系统，包括便携式阅读器和一次性检测盒，通过定量检测AFP快速诊断肝细胞癌（HCC）。在第一年，将设计和制造一个20传感器的甚高频（VHF）生物芯片，同时将开发和集成盒的全血处理组件，以形成一个包罗万象的盒。分布式独立电子系统也将在第一年设计和测试。第2年将涉及读卡器组件的集成，以形成一个独立的系统，此外，将对全包式试剂盒进行修改，以与读卡器接口，允许即插即用操作。将通过检测登记样本中的HCC生物标志物并与当前标准治疗进行比较来评价集成系统的性能。

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.