Malarial retinopathy screening system for improved diagnosis of cerebral malaria

总结 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，仅非洲就有超过2.13亿人感染疟疾，夺去了38.1万人的生命， 其中65%以上是5岁以下的非洲儿童。由于高 CM的发病率，它往往被误诊为其他具有类似症状的病理，导致 CM的高假阳性率，不正确的治疗，以及导致的死亡率或神经系统疾病 残疾。目前CM临床诊断标准治疗的特异性（物理治疗） 症状、昏迷和疟疾寄生虫检测，如快速诊断检测） 百分之六十一因此，市场需要一种高度特异性、低成本和易于使用的 测试，以改善CM诊断和挽救生命。由于疟疾视网膜病变（MR）大于95%， 具体到CM的存在，视网膜MR筛查是一种有效的手段，以帮助 提高CM诊断的特异性。在现行标准的基础上进行MR筛查 提高了CM诊断的特异性从61%到100%。 VisionQuest Biomedical开发了第一款全自动MR检测软件ASPIRE 与低成本和便携式视网膜照相机集成，可以通过 最低限度的培训人员，如医疗技术人员或护士，而不需要 眼科专家我们已经组建了一个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; 并在非洲的目标市场推出ASPIRE。该团队将验证并准备ASPIRE 进行监管审批，并最终确定营销和商业推广战略。 在II-B阶段，VisionQuest Biomedical的研究团队部署了一个功能齐全的临床 ASPIRE版本，并在非洲的九个疟疾诊所进行了测试，结果显示， 检测MR的性能和可用性，无需眼科专家。在CRP中， 将对ASPIRE的技术和临床性能进行确认，并将 商业准备与监管许可。我们将通过以下四个具体措施来实现这一目标： 目标。在第一个目标中，将验证用于MR检测的软件系统，以使其符合 设计控制。在第二个目标中，我们将在非洲的25个诊所部署ASPIRE， 安全性和有效性以及促进市场牵引力。第三个目标将侧重于准备 ASPIRE用于监管提交。第四个目标是完善非洲医疗保健市场 为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， 最终确定营销和推广策略。在CRP之后的一年内，我们的目标将是部署 ASPIRE在非洲5个国家的200多个疟疾诊所。

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.