Point of Care Technologies for Nutrition, Infection, and Cancer for Global Health (PORTENT)

1.0总体摘要 我们建议建立PORTENT -“营养、感染和癌症的即时护理技术” 以康奈尔大学为中心，与哥伦比亚大学和麦吉尔大学合作。 最近的《柳叶刀》诊断委员会报告指出，“诊断差距在小学一级最为严重， 医疗保健，在低收入和中低收入国家，只有约19%的人口 获得最简单的诊断测试.穷人、边缘化者、年轻人或受教育程度较低的人 最少的诊断”为这些人群开发可穿戴设备具有挑战性。需求是独特的， 用户有不同的资格，商业化的路径不同，设置有变化， 基础设施，监管机构有独特的要求，利益相关者是多种多样的。的 PORTENT中心是独一无二的，因为它（1）专注于全球的初级卫生保健;（2）满足 在美国和国际上最脆弱的;（3）使广泛的诊断技术， 在全球范围内得到验证，同时在国际上发展专门知识和建设能力 甚至在中心之外产生最大的影响。该中心建立在我们几十年的国际经验， POC系统的验证、部署和商业化，并结合临床验证和卫星 遍布四大洲的技术站点，能够对不同人群进行测试，并具有独特的用户群。 我们的方法从根本上是由5个关键的差异化要素：（1）严格的方法，以需求 通过建立一个由联合国开发计划署（开发署） 需要评估咨询委员会;（2）在非常广泛的范围内验证可持续发展技术的能力 （3）在纽约市、厄瓜多尔、印度和乌干达建立的种群和生物标本; 建立“全球健康护理点技术的实验室到市场加速器”， 为PORTENT项目提供商业化和技术市场支持;（4）独特的培训机会， 为中低收入国家的医疗工作者举办关于使用呼吸机设备和临床轮换的知识传授讲习班 在我们的国际网站上为可编程逻辑器件开发人员提供;（5）访问团队的工业合作伙伴网络，诊断 公司、监管专家、风险投资集团以及国内外非政府组织 组织的为了说明我们将通过PORTENT资助什么，我们描述了四个“第一年”项目，（1）使 宫颈癌的早期筛查，（2）铁状态的测定，使贫血筛查，（3）艾滋病毒和 性传播疾病的多重检测，和（4）更广泛，更便宜，更准确的疟疾检测。 到第五年年底，PORTENT将：启动20个独立的可再生能源技术项目（其中30%来自外部 美国），在全球健康实验室到市场加速器计划中招募约15个团队，培训30名医疗保健工作者 从中低收入国家获得关于使用可持续发展技术的经验，并为技术开发人员提供20多个临床轮换。

1.0 Overall Abstract We propose the establishment of PORTENT – “Point-of-Care Technologies for Nutrition, Infection and Cancer for Global Health” centered at Cornell University in partnership with Columbia and McGill Universities. The recent Lancet Diagnostic Commission report states that the “diagnostic gap is most severe at the level of primary health care, in which only about 19% of populations in low-income and lower-middle-income countries have access to the simplest of diagnostic tests … People who are poor, marginalized, young, or less educated have the least access to diagnostics.” Developing PoC devices for these populations is challenging. The needs are unique, the users have disparate qualifications, the path to commercialization is different, the settings have variable infrastructure, the regulatory agencies have distinctive requirements, and the stakeholders are diverse. The PORTENT Center is unique as it (1) focuses on primary health care globally; (2) addresses the needs of the most vulnerable in the US and internationally; and (3) enables a broad range of diagnostic technologies to be validated on a global scale while simultaneously developing expertise and building capacity internationally to have the most impact even beyond the center. The center builds on our decades of international experience in validation, deployment, and commercialization of POC systems and incorporates clinical validation and satellite technology sites across four continents enabling testing on diverse populations and with a unique set of users. Our approach is fundamentally enabled by 5 key differentiable elements: (1) A rigorous approach to Needs Assessment through the establishment of an annual Global PoC Needs Assessment Consensus developed by a Needs Assessment Advisory Board; (2) The ability to validate PoC technologies on an exceptionally broad range of established populations and biospecimens in New York City, Ecuador, India, and Uganda; (3) The establishment of a “Lab-to-Market accelerator for Global Health Point of Care Technologies” to provide commercialization and tech-to-market support for PORTENT projects; (4) Unique training opportunities and knowledge transfer workshops for healthcare workers in LMICs on the use of PoC devices and clinical rotations at our international sites for PoC developers; (5) Access to the team’s network of industrial partners, diagnostics companies, regulatory experts, venture capital groups, and domestic & international non-governmental organizations. Illustrative of what we will fund through PORTENT, we describe four “Year 1” projects that (1) enable early screening of cervical cancer, (2) determination of iron status enabling anemia screening, (3) combined HIV and multiplexed detection of sexually transmitted diseases, and (4) broader, cheaper, and more accurate malaria testing. By the end of year 5, PORTENT will: initiate 20 independent PoC technology projects (with 30% from outside US), engage ~ 15 teams in the Global Health Lab-to-Market accelerator program, train 30 health care workers from LMICs on use of PoC technologies, and provide >20 clinical rotations for technology developers.