Phase II year
2021
(last award dollars: 2022)
Phase II Amount
$1,992,098
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 highincidence of CM, it is often misdiagnosed for other pathologies with similar symptoms, leadingto a high false positive rate for CM, incorrect treatment, and resulting mortality or neurologicaldisability. The specificity of the current standard of care for clinical diagnosis of CM (physicalsymptoms, coma, and malaria parasite test such as rapid diagnostic testing) is reported around61%. Therefore, there is a significant market need for a highly specific, low-cost, and easy-to-usetest 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 inand improve the specificity of CM diagnosis. Screening for MR in addition to the current standardof care improves the specificity of CM diagnosis from 61% to 100%.VisionQuest Biomedical has developed ASPIRE, the first fully automated MR detection softwareintegrated with a low-cost and portable retinal camera, a system that can be operated byminimally trained personnel such as medical technician or nurse without the need of anophthalmic specialist. We have assembled a multidisciplinary team of regulatory consultants,commercialization experts, business development specialists, and clinicians; to clinically deployand launch ASPIRE in our target market in Africa. This team will validate and prepare ASPIREfor 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 clinicalversion of ASPIRE and tested it in nine malaria clinics in Africa, which demonstrated excellentperformance 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 tocommercial readiness with regulatory clearance. We will accomplish this through four specificaims. In the first aim, the software system for MR detection will be validated to bring it underdesign controls. In the second aim, we will deploy ASPIRE at 25 clinics in Africa to demonstratesafety and efficacy as well as to promote market traction. The third aim will focus on preparingASPIRE for regulatory submission. In the fourth aim, we will complete African healthcare marketresearch for a startup market of 5 countries (Malawi, Zambia, Kenya, Uganda, Rwanda) andfinalize marketing and rollout strategy. Within one year after CRP, our goal will be to deployASPIRE in more than 200 malaria clinics across 5 countries in Africa.
Public Health Relevance Statement: Narrative
Cerebral malaria (CM) is a life-threatening clinical syndrome associated with malarial infection,
which claims hundreds of thousands of lives of African children every year. The detection of
retinal biomarkers of CM, called malarial retinopathy, can improve the diagnostic accuracy of
CM. This project proposes the development, clinical deployment, and commercialization of a
fully automated malarial retinopathy detection system consisting of a low-cost retinal camera and
automatic malarial retinopathy detection software.
Project Terms: <0-11 years old><5 year old><5 years of age>| | |
