Novel Diagnostic Biomarker Discovery and Validation for Malaria and Select Neglected Tropical Diseases (NTDs)

Fast-Track proposals will be accepted. Direct-to-Phase II proposals will NOT be accepted. Number of anticipated awards: 2-3 Budget (total costs): Phase I: $300,000 for up to one year; Phase II: $1,500,000 for up to 3 years. Background Diagnostics in current use for malaria and specific NTDs (visceral leishmaniasis, lymphatic filariasis, onchocerciasis, schistosomiasis) do not meet the sensitivity and/or specificity thresholds required to achieve elimination goals. As diseases Page 117 approach elimination, decreased prevalence and intensity of infection require highly sensitive and specific diagnostics to ensure that all true cases are detected and treated, to avoid false negatives, and to manage the larger volume of samples that must be tested to confirm interruption of transmission. NTDs that are targeted by mass drug administration (MDA), such as lymphatic filariasis, onchocerciasis and schistosomiasis, require the use of diagnostics that are increasingly sensitive and specific when progressing from monitoring, to MDA-stopping, to post-elimination surveillance. For P. falciparum malaria, rapid diagnostic tests (RDTs) in current use lack sensitivity to detect the asymptomatic reservoir, which contributes to onward transmission. Additionally, some P. falciparum isolates have deleted the targets (histidine-rich protein genes pfhrp2/3) of the most sensitive RDTs, therefore escaping detection all together. Assays to detect non-falciparum malaria species also lack needed sensitivity. Disease elimination goals are further threatened by an insufficient pipeline of novel, validated diagnostic biomarkers.