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.

摘要 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 每年数以百万计。根治间日疟原虫和卵形疟原虫需要8-氨基喹啉催眠杀菌治疗 针对急性血液期(裂殖体)和休眠肝期(催眠期)。唯一的催眠药 目前可用的治疗方法是伯氨喹和最近批准的他非奎因，这两种药物都可以引起急性 葡萄糖-6-磷酸脱氢酶(G6PD)缺陷者的溶血性贫血。因为有效 出于对药物性贫血的担忧，临床医生对开出伯喹或伯喹的处方犹豫不决，而且往往不开。 他非诺喹由于人群患病率高(8%)，或4亿人，具有不同程度的遗传性 G6PD缺乏症。世界卫生组织(WHO)目前建议以青蒿素为基础的联合 治疗(ACT)作为一线治疗，使用较大剂量的传输阻断伯氨喹和他非诺喹 当G6PD状态已知时，推荐给被诊断为疟原虫的患者。不幸的是， G6PD状态的护理点筛查明显缺乏，降低了非常有效的频率 伯氨喹和他苯喹用于根治。PreQuine平台将解决这一未得到满足的需求 快速、经济高效地同时筛查和监测患者的G6PD和HGB水平。包括在 PreQuine平台试剂盒是试纸，能够量化G6PD酶和HGB水平的仪器，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， 以及与能够实时提供关于适当治疗的指导的临床医生的直接连接。 虽然正在进行的第二阶段将成功地敲定创新的基础技术(仪表和试纸)，但在 仍然是成功商业化发射所需的几个关键发展领域，我们可以 通过商业准备试验(CRP)计划发表讲话。更具体地说，完全商业化 广泛采用试条需要额外的技术配件和配套基础设施， 包括优化仪表开发和验证、软件移动应用开发和验证，以及 系统打包。一项全面的监管战略将需要在国内和 国际市场。一旦制定了战略，技术产品开发将需要整合 拥有完全合规的质量管理体系，以支持产品发布和上市后监督。 将概念化和实施商业推出、市场规模和分销战略，以确保 存在一个完整的生态系统，将公司从技术开发转变为自给自足的商业销售。 最后，将使用所有更新的技术规范和质量体系来生产第一件系统套件 对照，并在多中心临床研究中部署，以证明安全性和有效性。