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Malarial retinopathy screening system for improved diagnosis of cerebral malaria

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1SB1AI162452-01
Agency Tracking Number: SB1AI162452
Amount: $2,992,098.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PAR20-129
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-05-06
Award End Date (Contract End Date): 2023-04-30
Small Business Information
Albuquerque, NM 87106-4358
United States
DUNS: 116935740
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (505) 508-1994
Business Contact
Phone: (505) 508-1994
Research Institution

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.

* Information listed above is at the time of submission. *

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