Malarial retinopathy screening system for improved diagnosis of cerebral malaria

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.