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.

摘要 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，仅非洲就有2.13亿人感染疟疾，38.1万人丧生， 其中65%以上是5岁以下的非洲儿童。作为高水平的结果 CM的发病，常被误诊为其他具有相似症状的病理，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 残疾。目前临床诊断CM(体格检查)的护理标准的特殊性 症状、昏迷和疟疾寄生虫测试，如快速诊断测试)的报道 61%。因此，市场非常需要一种高度专用性、低成本和易于使用的 测试以提高对CM的诊断和挽救生命。由于疟疾视网膜病变(MR)大于95% 对于CM的存在，视网膜MR筛查是一种有效的辅助手段 提高CM诊断的特异性。除现行标准外的MR筛查 CARE将CM诊断的特异度从61%提高到100%。 VisionQuest Biomedical开发了首个全自动磁共振检测软件ASPIRE 集成了低成本和便携式视网膜摄像头，可以由 受过最低程度培训的人员，如医务人员或护士，而不需要 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、业务开发专家和临床医生；临床部署 并在我们的非洲目标市场推出Aspire。该团队将验证和准备ASPIRE 进行监管审批，并最终确定营销和商业推广战略。 在第二阶段-B阶段，VisionQuest Biomedical的研究团队部署了一种全功能临床 ASPIRE版本，并在非洲的九个疟疾诊所进行了测试，证明它非常好 无需眼科专家即可检测MR的性能和可用性。在CRP中， ASPIRE将通过技术和临床性能验证，并将被带到 具有监管许可的商业准备情况。我们将通过四个具体的途径来实现这一点 目标。在第一个目标中，将验证用于MR检测的软件系统以将其纳入 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以演示 安全性和有效性，以及促进市场吸引力。第三个目标将集中在准备上 渴望监管机构的提交。第四个目标，我们将完成非洲医疗保健市场 对5个国家(马拉维、赞比亚、肯尼亚、乌干达、卢旺达)的创业市场进行研究，并 最终确定营销和推广战略。在CRP之后的一年内，我们的目标是部署 渴望在非洲5个国家的200多家疟疾诊所工作。