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

全球健康营养、感染和癌症护理点技术 (PORTENT)

• 批准号: 10714506
• 负责人: David Carl Erickson
• 金额: $ 160.64万
• 依托单位: CORNELL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-13 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10714506
• 关键词: Address; Africa; Anemia; Area; Asia; Biological Sciences; Businesses; COVID-19 pandemic; Capital; Cervical Cancer Screening; Clinical; Communicable Diseases; Consensus; Development; Device or Instrument Development; Devices; Diagnostic; Diagnostic tests; Direct Costs; Disparate; Ecology; Ecuador; Educational workshop; Elements; Engineering; Entrepreneurship; Event; Funding; Generations; HIV; Health Personnel; Healthcare Systems; Human; Incubators; India; Industrialization; Infection; Infrastructure; Institution; International; Iron; Knowledge; Leadership; Letters; Low income; Malaria; Malignant Neoplasms; Marketing; Mind; Modeling; Needs Assessment; Network-based; New York City; Nongovernmental Organizations; North America; Patients; Persons; Point of Care Technology; Population; Population Heterogeneity; Positioning Attribute; Primary Care; Primary Health Care; Qualifying; Regulatory Affairs; Reporting; Rotation; Sexually Transmitted Diseases; Site; South America; System; Technology; Testing; Therapeutic; Training; Translations; Travel; Uganda; United States; United States National Institutes of Health; Universities; Validation; Veterans; clinical research site; college; commercialization; diagnostic technologies; early screening; experience; global health; health care disparity; interest; low and middle-income countries; marginalization; marginalized population; multiplex detection; next generation; nutrition; point of care; point-of-care diagnostics; programs; research and development; screening; statistics; technology development; technology validation; training opportunity

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.

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” 全球健康”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，“初级诊断水平的诊断差距最为严重”。 医疗保健，低收入和中低收入国家只有约 19% 的人口享有医疗保健服务 获得最简单的诊断测试……穷人、少数民族、年轻人或受教育程度较低的人有 为这些人群开发 PoC 设备具有挑战性，其需求是独特的。 用户资质不同，商业化路径不同，设置也存在差异 基础设施、监管机构有独特的要求、利益相关者也多种多样。 PORTENT 中心的独特之处在于 (1) 专注于全球初级卫生保健；(2) 满足人们的需求； 在美国和国际上最脆弱的；(3) 使广泛的诊断技术成为可能 在全球范围内进行验证，同时在国际上发展专业知识和能力建设 该中心建立在我们数十年的国际经验的基础上。 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和一组独特的用户进行测试。 我们的方法从根本上是由 5 个关键的可区分元素实现的：(1) 严格的需求方法 通过建立年度全球 PoC 需求评估共识来进行评估，该共识由 需求评估顾问委员会；(2) 在极其广泛的范围内验证 PoC 技术的能力 (3) 的 建立“全球健康护理点技术的实验室到市场加速器”，以提供 PORTENT 项目的商业化和技术市场支持； (4) 独特的培训机会和 为中低收入国家的医护人员举办关于 PoC 设备使用和临床轮换的知识传授研讨会 在我们为 PoC 开发人员提供的国际站点； (5) 访问团队的工业合作伙伴网络、诊断； 企业、监管专家、风险投资集团、国内外非政府组织 为了说明我们将通过 PORTENT 资助的项目，我们描述了四个“第一年”项目：(1) 宫颈癌的早期筛查，(2) 确定铁状态以进行贫血筛查，(3) 结合艾滋病毒和 性传播疾病的多重检测，以及（4）更广泛、更便宜和更准确的疟疾检测。 到第 5 年年底，PORTENT 将： 启动 20 个独立的 PoC 技术项目（其中 30% 来自外部） 美国），让约 15 个团队参与全球健康实验室到市场加速器计划，培训 30 名医疗保健工作者 中低收入国家使用 PoC 技术，并为技术开发人员提供超过 20 次临床轮换。