PFI-TT: Immuno-Dx: A Biomedical Platform Technology for Personalized Diagnostics

该创新-技术转化伙伴关系（PFI-TT）项目的更广泛影响/商业潜力是开发一种能够检测和监测患者抗感染能力的生物医学设备。所提出的技术解决了医院急诊部门未满足的需求，可用于监测患者对治疗性治疗的反应并识别高风险患者。最小可行原型（MVP）将从概念验证生物传感技术（称为Immuno-Dx）开发，该技术的核心是监测血细胞杀死病原体的自然能力。Immuno-Dx可应用于以下领域：（i）更好地了解患者对病原性感染的免疫系统反应，（ii）制药公司开发新的免疫治疗药物，以及（iii）医生制定患者治疗策略。生物传感装置将能够提供关于患者在30分钟内从一滴全血中抵抗感染的能力的信息。这个PFI-TT项目将使劳动力发展的精神与国家科学基金会的使命培训下一代科学家和工程师的技术和创业技能，同时创造一个国家医疗保健和援助美国经济的直接影响。拟议项目的主要目标是开发一种集成了电子设备、数据处理、用户界面和片上样品处理的MVP，以便在30分钟内从一滴全血中进行吞噬测定。所提出的技术的价值主张在于其能够提供关于患者对感染和治疗的免疫反应的重要信息，以满足在医院急诊室环境中对患者进行个性化监测的未满足的需求。主要创新功能包括在30分钟内自动检测患者抵抗全血感染的能力，集成机器学习（ML）模型以提高准确性，手动样品处理步骤自动化，以及开发具有集成电子器件，数据处理和触摸控制用户界面的用户启发式3D打印阅读器。Immuno-Dx的当前关键属性和价值主张也可用于其他领域，例如，感染性疾病、自身免疫性疾病和癌症，并且可以由研究人员、制药公司、临床医生、医疗保健提供者和生物技术公司使用。PFI-TT提案的潜在成果将是Immuno-Dx技术从研究者研究实验室向商业创业公司的转变。该奖项反映了NSF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 Partnerships for Innovation - Technology Translation (PFI-TT) project is on developing a biomedical device capable of detecting and monitoring patient's ability to combat infections. The proposed technology addresses the unmet need in emergency department settings of the hospitals where it can be used to monitor patients’ response to therapeutic treatments and identify high-risk patients. A minimal viable prototype (MVP) will be developed from proof-of-concept biosensing technology (called Immuno-Dx), which is centered around monitoring natural ability of blood cells to kill pathogens. Immuno-Dx can have applications in areas (i) to better understand immune system responses of patients to pathogenic infections, (ii) to develop new immunotherapy drugs by pharmaceutical companies, and (iii) to strategize patient treatments by physicians. Biosensing device will be able to provide information regarding patients’ ability to combat infection within 30 min from a drop of whole blood. This PFI-TT project will enable workforce development in spirit with the NSF mission of training next generation of scientists and engineers in technical and entrepreneurial skills, while creating a direct impact on national healthcare and aiding the US economy. The proposed project’ primary objective is to develop an MVP with integrated electronics, data processing, user interface, and onchip sample processing to perform the phagocytosis assay within 30 min from a drop of whole blood. Value proposition of proposed technology lies in its ability to provide vital information about patients’ immune response to infections and therapeutics, to fulfil unmet need for personalized monitoring of patients in emergency department settings of the hospitals. The key innovative features include automated sensing of patient’s ability to combat infections from a drop of whole blood within 30 min, integration of machine learning (ML) models for improved accuracy, automation of manual sample processing steps, and developing a user-inspired 3D printed reader with integrated electronics, data processing and touch controlled user interface. Current key attributes and value proposition of Immuno-Dx can also be leveraged in other areas e.g., infectious diseases, autoimmune disorders, and cancer and can be used by researchers, pharmaceutical companies, clinicians, healthcare providers, and biotech companies. The potential outcome of PFI-TT proposal will be the transition of Immuno-Dx technology from investigator research laboratory to a commercial startup company.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.