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Diagnostics to Enable Malaria and Neglected Tropical Diseases (NTDs) Elimination


Fast-Track proposals will be accepted. Number of anticipated awards: 1-2 Budget (total costs):
Phase I: $225,000 for up to 1 year
Phase II: $1,500,000 for up to 3 years
Malaria and Neglected Tropical Diseases (NTDs) disproportionately affect the poorest people in developing countries. The World Health Organization disease burden reduction targets for 2030 include global elimination of leprosy, lymphatic filariasis, trachoma, onchocerciasis, and human African trypanosomiasis (HAT), and a reduction in the malaria mortality rate by 90%. Impressive progress is being made towards these goals. For example, malaria incidence rates fell 37% globally between 2000 and 2015; an 80% reduction in new HAT cases was seen between 2000 and 2014, and 18 countries have been able to stop preventive chemotherapy for lymphatic filariasis, as have eight countries for trachoma. However, we currently lack diagnostic tools with optimal sensitivity and specificity for use in the elimination and post-elimination phases. For example, microscopy and available rapid diagnostic tests (RDTs) have been largely adequate for malaria control but lack the sensitivity to detect asymptomatic infections. In the case of HAT, current diagnostic methods are limited by sensitivity and

reproducibility, and the lumbar puncture method is invasive and less than ideal. For these diseases slated for elimination, there is a pressing need for new diagnostic tools that can detect subclinical infections that serve as a disease reservoir and contribute to onward transmission. Such diagnostics would be intended for use in active-infection-detection interventions such as mass-screen-and-treat, targeted mass-drug-administration, post-elimination surveillance and for detecting cases in low-prevalence areas.
Project Goal
The goal of this project is to develop a low-cost, diagnostic platform with appropriate sensitivity and specificity for the detection of subclinical malaria or select NTD infections (leprosy, lymphatic filariasis, trachoma, onchocerciasis, HAT) for use in disease elimination campaigns in resource-limited settings. The final product should demonstrate the necessary sensitivity and specificity to reliably detect asymptomatic infections that are outside the limits of detection of currently available diagnostics.
Phase I Activities can include but are not limited to:
 Development of a prototype point-of-care diagnostic device that can identify one or more target pathogens in low biomass infections.  Determination of the sensitivity, specificity and other performance characteristics (e.g. time to result, limit of detection, test stability) of the diagnostic.  Initial testing on laboratory isolates.
Phase II Activities can include but are not limited to:
 Development of well-defined test platform under good manufacturing practices (GMP).
 Scale up and production for multi-site evaluations using clinical isolates.
 Product development strategy for regulatory approval and demonstration of clinical application.
This SBIR will not support:
 The design and conduct of clinical trials (see for the NIH definition of a clinical trial). For clinical trial support, please refer to the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement program announcement or the NIAID Investigator-Initiated Clinical Trial Resources webpage.

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