HLS-Highly-Sensitive, One-minute, Portable Diagnostic for Malaria Elimination

Period of Performance: 03/02/2017 - 02/28/2018

$741K

Phase 2 SBIR

Recipient Firm

Hemex Health, Inc.
PORTLAND, OR 97210
Principal Investigator

Abstract

Project Summary While the mosquito-borne illness malaria, is entirely preventable and treatable, 95 countries are currently plagued by malaria transmission and half the world?s population is at risk of malaria. A great deal of progress has been made against malaria as a result of the massive rollout of resources and technology focused on malaria control. Thirty-five of the 95 affected countries, including China and India, are now focusing on reaching malaria elimination by 2030. To be successfully eliminate malaria these countries need to reach out and screen populations and treat malaria in remote areas, in communities, and along borders. Today, eliminating malaria is hindered because of the lack of a portable diagnostic screening tool that?s capable of quickly detecting all types of malaria, even at very low levels of infection. Studies have demonstrated that interrupting transmission requires a focus on identification of all parasite carriers, both symptomatic and asymptomatic. Current field-based diagnostics (light microscopy and RDTs) are not sensitive enough for this task and molecular diagnostics (LAMP and PCR) lack the affordability, portability, and high throughput. The goal of this project is to develop and test an affordable, portable, one-minute, highly-sensitive malaria diagnostic device that accelerates efforts to eliminate malaria. A multidisciplinary team developed magneto-optical detection (MOD) which finds malaria using the biomarker hemozoin. Using hemozoin, it is able to accurately detect all five species of malaria including those with HRP2 deletion and is sensitive even at very low concentrations of parasites. MOD is ideal for diagnostic screening to aid elimination efforts. It is a rugged, portable device that can be easily used by entry-level healthcare workers anywhere. In one-minute it provides accurate results on all species at 10X the sensitivity of microscopy and it is highly affordable at $1/test. In this Phase II project the team will advance the product towards commercialization by finalizing the product design with end-user input, conducting bench testing to characterize performance, and performing validation testing in multiple field settings including Peru, Kenya and India. The overall objective is to support developing country teams, in their move towards malaria elimination, by producing the tool they need to quickly identify and treat malaria everywhere.