I-Corps: Multiplex diagnostic assay using interdigitated nano-sensing technology implemented point-of-care device

I-Corps项目更广泛的影响/商业潜力是开发用于即时诊断的多路诊断分析和设备，使用交叉数字化纳米传感技术。建议的初步应用是卵巢癌的检测和监测。卵巢癌的早期诊断是困难的，因为良性状况通常混淆其症状。目前，在美国大约有25万女性患有卵巢癌，卵巢癌的复发率超过70%。该技术可以提供卵巢癌的早期检测和监测功能，提高生存率，挽救成千上万妇女的生命。此外，拟议的诊断平台可以扩展到在商业诊断实验室检测许多其他疾病，如其他癌症、疟疾和Covid-19。设想所提议的技术可用于医院和医疗中心以及医生办公室、药房和药店，这可能使其更容易获得，并可能挽救更多的生命，改善患者的生活质量和医疗保健环境。I-Corps项目的基础是开发一种多路诊断试验和设备，使用数字化纳米传感技术进行即时诊断。该技术旨在在设备的微通道中自发分离生物分子，并以高精度检测多种生物标志物。该技术最初将用于卵巢癌检测，其工作原理是在极低的检测限（pico-level）下量化各种卵巢癌生物标志物的浓度。它是一个独立的设备，由两个主要部分组成：一个微流体通道，能够在毛细血管血流中自发地分离血浆；一个生物传感平台，与微通道集成，包含多个纳米生物传感器，用于检测分离血浆中微米级浓度的各种抗原。该技术可用于准确检测靶向生物标志物的浓度，协助癌症的早期诊断，并在监测过程中评估治疗效果。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is the development of the multiplex diagnostic assay and device using interdigitated nano-sensing technology for point-of-care diagnostics. The proposed initial application is the detection and monitoring of ovarian cancer. The early diagnosis of ovarian cancer is difficult because the benign condition usually obfuscates its symptoms. Currently, there are approximately 250,000 women living with ovarian cancer in the U.S., and ovarian cancer has more than a 70% chance to recur. The proposed technology may provide early detection of the ovarian cancer and monitoring functions to improve the survival rate and save thousands of women lives. In addition, the proposed diagnostic platform may be expanded to detect many other diseases, such as other cancers, malaria, and Covid-19, at commercial diagnostic laboratories. It is envisioned that the proposed technology may be used in hospitals and medical centers as well as physician's offices, pharmacies, and drug stores, which may make it more accessible and may save more lives and improve the quality of patients’ lives and health care environment.This I-Corps project is based on the development of a multiplex diagnostic assay and device using interdigitated nano-sensing technology for point-of-care diagnostics. The proposed technology is designed to separate biomolecules spontaneously in the microchannel of the device and detect multiplex biomarkers with high accuracy. The proposed technology initially will be used to test for ovarian cancer, and works by quantifying the concentrations of various biomarkers for ovarian cancer at an extremely low limit of detection (pico-level). It is a standalone device that consists of two main components: a microfluidic channel that is capable to separate the blood plasma spontaneously in the capillary blood flow, and a biosensing platform integrated with microchannels that contain multiple nano-biosensors used to detect various antigens at pico-level concentrations in the separated plasma. The proposed technology may be used to accurately test the concentration of targeted biomarkers and assist in the early diagnosis of cancer as well evaluate the efficacy of the treatment during the monitoring process.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.