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 脑型疟疾（CM）是一种与疟疾感染相关的危及生命的临床综合征。 2018 年，疟疾仅在非洲就影响了超过 2.13 亿人，夺去了 381,000 人的生命， 其中超过65%是5岁以下的非洲儿童。由于高 CM 的发病率，经常被误诊为具有类似症状的其他疾病，导致 CM 的高假阳性率、不正确的治疗以及由此导致的死亡率或神经系统疾病 残疾。当前 CM 临床诊断护理标准（物理诊断）的特异性 症状、昏迷和疟疾寄生虫测试（例如快速诊断测试）的报告大约 61%。因此，市场迫切需要一种高度特异性、低成本且易于使用的方法。 测试以改善 CM 诊断并挽救生命。由于疟疾视网膜病变 (MR) 大于 95% 针对 CM 的存在，视网膜 MR 筛查是一种有效的辅助手段 并提高 CM 诊断的特异性。除现行标准外还进行 MR 筛查 护理将 CM 诊断的特异性从 61% 提高到 100%。 VisionQuest Biomedical 开发了 ASPIRE，第一个全自动 MR 检测软件 与低成本便携式视网膜相机集成，该系统可以通过 受过最低限度培训的人员，例如医疗技术人员或护士，无需 眼科专家。我们组建了一支多学科的监管顾问团队， 商业化专家、业务开发专家和临床医生；临床部署 并在非洲目标市场推出 ASPIRE。该团队将验证并准备 ASPIRE 获得监管许可并最终确定营销和商业推广策略。 在 II-B 阶段，VisionQuest Biomedical 的研究团队部署了一个功能齐全的临床 版本的 ASPIRE 并在非洲的九个疟疾诊所进行了测试，结果显示出良好的效果 检测 MR 的性能和可用性，无需眼科专家。在CRP中， ASPIRE 将经过技术和临床性能验证，并将被带到 商业准备和监管许可。我们将通过四项具体措施来实现这一目标 目标。第一个目标是对 MR 检测软件系统进行验证，使其纳入研究范围。 设计控制。第二个目标是，我们将在非洲 25 个诊所部署 ASPIRE，以展示 安全性和有效性以及促进市场吸引力。第三个目标将侧重于准备 ASPIRE 寻求监管提交。第四个目标，我们将完善非洲医疗保健市场 对 5 个国家（马拉维、赞比亚、肯尼亚、乌干达、卢旺达）的初创市场进行研究 最终确定营销和推广策略。 CRP 实施后一年内，我们的目标是部署 ASPIRE 遍布非洲 5 个国家的 200 多个疟疾诊所。