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.

Public Health Relevance

Half the world is still at risk of malaria; however, recent progress has enabled 35 countries to strive for elimination by 2030. Although these countries will need to reach out to identify and treat malaria in remote areas and communities, they lack a portable diagnostic screening tool that is capable of quickly detecting all types of malaria even at low levels of infection. The goal of the proposed work is to develop and test the first affordable, portable, one-minute, highly- sensitive malaria diagnostic device that accelerates efforts to eliminate malaria.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
1R44AI131810-01
Application #
9348492
Study Section
Special Emphasis Panel (ZRG1-IMST-L (10)B)
Program Officer
Rao, Malla R
Project Start
2017-03-02
Project End
2019-02-28
Budget Start
2017-03-02
Budget End
2018-02-28
Support Year
1
Fiscal Year
2017
Total Cost
$740,558
Indirect Cost
Name
Hemex Health, Inc.
Department
Type
Domestic for-Profits
DUNS #
080341719
City
Portland
State
OR
Country
United States
Zip Code
97210