Malarial retinopathy screening system for improved diagnosis of cerebral malaria

疟疾视网膜病变筛查系统可改善脑型疟疾的诊断

• 批准号: 10401912
• 负责人: Vinayak S Joshi
• 金额: $ 99.29万
• 依托单位: VISIONQUEST BIOMEDICAL INC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-06 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10401912
• 关键词: 5 year old; Affect; Africa; African; Artificial Intelligence; Biological Markers; Businesses; Cerebral Malaria; Cessation of life; Child; Childhood; Clinic; Clinical; Clinical Research; Clinical Trials; Coma; Computer software; Consult; Country; Detection; Development; Diagnosis; Diagnostic tests; Disease; Expert Systems; Feedback; Goals; Government; Grant; Health; Healthcare Market; Human Resources; Incidence; Institution; Institutional Review Boards; Internet; Kenya; Lesion; Letters; Life; Malaria; Malaria Diagnosis; Malawi; Market Research; Marketing; Medical; Medical Device; Medicine; Neurologic; Nurses; Parasites; Pathology; Performance; Persons; Pharmacy facility; Phase; Policies; Rapid diagnostics; Readiness; Reporting; Research; Retina; Retinal Diseases; Rwanda; Safety; Series; Software Validation; Specialist; Specificity; Symptoms; Syndrome; System; Technology; Testing; Traction; Training; Uganda; Validation; Work; Zambia; clinical diagnosis; clinical research site; commercialization; cost; design; detection platform; diagnostic accuracy; disability; improved; malaria infection; mortality; multidisciplinary; physical symptom; portability; programs; research clinical testing; research study; screening; smartphone Application; software systems; standard of care; success; usability; verification and validation; web site

Summary Cerebral malaria (CM) is a life-threatening clinical syndrome associated with malarial infection. In 2018, malaria affected more than 213 million people in Africa alone and claimed 381,000 lives, more than 65% of whom were African children less than 5 years old. As a consequence of the high incidence of CM, it is often misdiagnosed for other pathologies with similar symptoms, leading to a high false positive rate for CM, incorrect treatment, and resulting mortality or neurological disability. The specificity of the current standard of care for clinical diagnosis of CM (physical symptoms, coma, and malaria parasite test such as rapid diagnostic testing) is reported around 61%. Therefore, there is a significant market need for a highly specific, low-cost, and easy-to-use test to improve CM diagnosis and save lives. Since Malarial retinopathy (MR) is greater than 95% specific to the presence of CM, retinal screening for MR represents an effective means to assist in and improve the specificity of CM diagnosis. Screening for MR in addition to the current standard of care improves the specificity of CM diagnosis from 61% to 100%. VisionQuest Biomedical has developed ASPIRE, the first fully automated MR detection software integrated with a low-cost and portable retinal camera, a system that can be operated by minimally trained personnel such as medical technician or nurse without the need of an ophthalmic specialist. We have assembled a multidisciplinary team of regulatory consultants, commercialization experts, business development specialists, and clinicians; to clinically deploy and launch ASPIRE in our target market in Africa. This team will validate and prepare ASPIRE for regulatory clearance as well as finalize the marketing and commercial rollout strategy. In Phase II-B, the research team at VisionQuest Biomedical deployed a fully-functional clinical version of ASPIRE and tested it in nine malaria clinics in Africa, which demonstrated excellent performance and usability for detecting MR, without the need of an ophthalmic expert. In CRP, ASPIRE will be validated for technical and clinical performance and will be brought to commercial readiness with regulatory clearance. We will accomplish this through four specific aims. In the first aim, the software system for MR detection will be validated to bring it under design controls. In the second aim, we will deploy ASPIRE at 25 clinics in Africa to demonstrate safety and efficacy as well as to promote market traction. The third aim will focus on preparing ASPIRE for regulatory submission. In the fourth aim, we will complete African healthcare market research for a startup market of 5 countries (Malawi, Zambia, Kenya, Uganda, Rwanda) and finalize marketing and rollout strategy. Within one year after CRP, our goal will be to deploy ASPIRE in more than 200 malaria clinics across 5 countries in Africa.

概括 脑疟疾（CM）是一种与疟疾感染相关的威胁生命的临床综合征。 2018年，疟疾仅在非洲就影响了超过2.13亿人，并夺走了381,000人的生命， 超过65％的非洲儿童不到5岁。由于高 CM的发病率通常被误诊到其他具有相似症状的病理中，导致 CM的高阳性率，不正确的治疗以及导致的死亡率或神经系统 残疾。当前护理标准的特异性CM临床诊断（物理 报告症状，昏迷和疟疾寄生虫测试，例如快速诊断测试） 61％。因此，市场需要高度特定，低成本且易于使用的市场 测试以改善CM诊断并挽救生命。由于疟疾视网膜病（MR）大于95％ 特定于CM的存在，MR的视网膜筛查代表了一种有效的手段 并提高CM诊断的特异性。除当前标准外，还筛选MR 护理的特异性将CM诊断的特异性从61％提高到100％。 VisionQuest Biomedical开发了Aspire，这是第一个完全自动化的MR检测软件 与低成本和便携式视网膜相机集成 受过最小培训的人员，例如医疗技术员或护士，无需 眼科专家。我们已经组建了一个由监管顾问组成的多学科团队， 商业化专家，业务发展专家和临床医生；临床部署 并在我们在非洲的目标市场上推出Aspire。该团队将验证并准备Asp​​ire 用于监管清算以及最终确定营销和商业推出策略。 在II-B期，VisionQuest生物医学的研究小组部署了一个功能功能的临床 Aspire的版本并在非洲的九个疟疾诊所进行了测试，该诊所表现出色 无需眼科专家而无需检测MR的性能和可用性。在CRP中， Aspire将通过技术和临床表现进行验证，并将被带到 商业准备，并有监管许可。我们将通过四个特定的 目标。在第一个目标中，将验证MR检测的软件系统以使其在 设计控件。在第二个目标中，我们将在非洲的25个诊所部署Aspire，以证明 安全和功效以及促进市场牵引力。第三个目标将集中于准备 渴望进行监管提交。在第四个目标中，我们将完成非洲医疗保健市场 针对5个国家（马拉维，赞比亚，肯尼亚，乌干达，卢旺达）的创业市场的研究 最终确定营销和推出策略。在CRP之后的一年之内，我们的目标是部署 在非洲5个国家 /地区的200多个疟疾诊所中的Aspire。