PreQuine Platform. A novel point of care device for the diagnosis andmonitoring of Glucose-6-Phosphate Dehydrogenase (G6PD)

PreQuine 平台。

• 批准号: 10681396
• 负责人: Robert Harper
• 金额: $ 98.24万
• 依托单位: ANALYTICAL DIAGNOSTIC SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-02-08 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10681396
• 关键词: Acute; Address; Adoption; Aminoquinolines; Anemia; Architecture; Area; Artemisinins; Biosensor; Blood; Caring; Clinical Research; Clinical Trials; Combined Modality Therapy; Computer software; Data; Development; Devices; Diagnosis; Diagnostic Reagent Kits; Diagnostic tests; Dose; Ecosystem; Ensure; Enzymes; Fingers; Frequencies; Glucosephosphate Dehydrogenase; Glucosephosphate Dehydrogenase Deficiency; Goals; Guidelines; Hemoglobin; Hemoglobin concentration result; Hemolytic Anemia; Individual; Infrastructure; Inherited; Intellectual Property; International; Legal patent; Life; Liver; Malaria; Market Research; Marketing; Measures; Monitor; Multi-site clinical study; Patient Monitoring; Patients; Performance; Persons; Pharmaceutical Preparations; Phase; Plasmodium; Plasmodium ovale; Plasmodium vivax; Population; Prevalence; Primaquine; Procedures; Process; Production; Protocols documentation; Rapid diagnostics; Readiness; Recommendation; Recording of previous events; Reporting; Safety; Sales; Site; Small Business Innovation Research Grant; Source; Specific qualifier value; System; Systems Development; Systems Integration; Technology; Testing; Time; Tube; Update; Validation; Venous; World Health Organization; base; care providers; commercial launch; commercialization; cost; cost effective; efficacy outcomes; innovation; manufacture; manufacturing run; manufacturing scale-up; meter; mobile application; novel; performance tests; point of care; point-of-care diagnostics; post-market; product development; programs; safety outcomes; screening; smartphone application; success; targeted treatment; test strip; transmission blocking; underserved area; validation studies

Abstract Malaria caused by Plasmodium Species threatens more than 2.5 billion people globally and sickens tens of millions annually. Radical cure for P. vivax and P. ovale requires 8-aminoquinoline hypnozoitocidal therapy targeting both the acute blood stage (schizonts) and dormant liver stage (hypnozoites). The only hypnozoitocidal therapies currently available are primaquine and recently approved tafenoquine, both of which can cause acute hemolytic anemia in Glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. Because of valid concerns of drug induced anemia, clinicians are hesitant to, and often do not, prescribe primaquine or tafenoquine due to the high population prevalence (8%), or 400 million individuals, with various levels of inherited G6PD deficiency. The World Health Organization (WHO) currently recommends artemisinin-based combination therapies (ACTs) as a frontline treatment, with higher doses of transmission blocking primaquine and tafenoquine recommended for patients diagnosed with Plasmodium Species, when G6PD status is known. Unfortunately, point-of-care screening for G6PD status is significantly lacking, reducing the frequency that highly effective primaquine and tafenoquine are used for radical cure. The PreQuine Platform will address this unmet need for rapid, cost-effective, simultaneous screening and monitoring of patients for G6PD and Hgb levels. Included within the PreQuine Platform kit are test strips, a meter capable of quantifying G6PD enzyme and Hgb levels, and a built-in cell phone application which allows global tracking using unique patient IDs, monitoring treatment history, and direct connectivity to clinicians able to provide guidance regarding appropriate treatment in real-time. While the ongoing Phase II will successfully finalize the innovative base technology (meter and test strip), there remain several key areas of development required for a successfully commercialized launch, which we can address through the Commercial Readiness Pilot (CRP) Program. More specifically, full commercialization for wide scale adoption of test strips requires additional technical accessories and supporting infrastructure, including optimized meter development and validation, software mobile app development and validation, and system packaging. A full regulatory strategy will require development and execution for both domestic and international markets. Once strategies are established, technical product development will require integration with a fully compliant quality management system to support product launch and post-market surveillance. Commercial launch, market scaling and distribution strategies will be conceptualized and implemented to ensure a full ecosystem exists to transition the company from technical development to self-sustaining commercial sales. Finally, the first article system kits will be produced using all updated technical specifications and quality system controls and deployed in Multicenter Clinical Studies to demonstrate safety and efficacy.

抽象的 由疟原虫引起的疟疾威胁着全球超过 25 亿人，并导致数十人患病 每年数百万。间日疟原虫和卵形疟原虫的根治需要 8-氨基喹啉催眠杀虫疗法 针对急性血液阶段（裂殖体）和休眠肝脏阶段（催眠体）。唯一的催眠杀虫剂 目前可用的治疗方法有伯氨喹和最近批准的他非诺喹，这两种药物均可引起急性 6-磷酸葡萄糖脱氢酶（G6PD）缺陷个体的溶血性贫血。由于有效 由于担心药物引起的贫血，临床医生对开伯氨喹或 他非诺喹的人群患病率很高（8%），即 4 亿人，具有不同程度的遗传性 G6PD缺乏症。世界卫生组织（WHO）目前推荐基于青蒿素的组合 疗法（ACT）作为一线治疗，使用更高剂量的伯氨喹和他非诺喹来阻断传播 当 G6PD 状态已知时，推荐用于诊断为疟原虫种类的患者。很遗憾， 严重缺乏 G6PD 状态的即时筛查，降低了高效筛查的频率 伯氨喹和他非诺喹用于根治。 PreQuine 平台将解决这一未满足的需求 快速、经济高效地同时筛查和监测患者的 G6PD 和 Hgb 水平。包含在 PreQuine 平台套件包括测试条、能够定量 G6PD 酶和 Hgb 水平的仪表以及 内置手机应用程序，允许使用唯一的患者 ID 进行全球跟踪、监控治疗历史、 并直接连接到能够实时提供适当治疗指导的临床医生。 虽然正在进行的第二阶段将成功完成创新基础技术（仪表和测试条），但 成功商业化发射所需的几个关键开发领域仍然存在，我们可以 通过商业准备试点 (CRP) 计划解决。更具体地说，全面商业化 测试条的广泛采用需要额外的技术配件和支持基础设施， 包括优化的仪表开发和验证、软件移动应用程序开发和验证，以及 系统封装。全面的监管战略需要国内外制定和执行 国际市场。一旦战略确定，技术产品开发就需要整合 拥有完全合规的质量管理体系来支持产品发布和上市后监督。 将构思并实施商业启动、市场规模和分销策略，以确保 存在一个完整的生态系统，可以将公司从技术开发过渡到自给自足的商业销售。 最后，第一篇系统套件将使用所有更新的技术规范和质量体系进行生产 控制并部署在多中心临床研究中以证明安全性和有效性。