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Recent emphasis on elimination and eradication (E&E) goals for malaria programs is changing the way experts evaluate malaria diagnostic tools and tactics. As malaria prevalence is driven to lower levels, the focus pivots toward low-density, subclinical infections and geographically and demographically concentrated reservoirs. The proportions of species and subspecies found in these reservoirs may also change in favor of higher fitness phenotypes that are more difficult to diagnose and treat. These changes present both threats and opportunities to existing diagnostic technologies and those in the development pipeline. Furthermore, the evolution of new tactics to combat malaria in low-prevalence areas necessitates a review of technologies in the product development pipeline to encourage development of appropriate tools for new diagnostics use-scenarios. In light of shifting goals, epidemiology, and tactics, this report focuses on enzyme linked immunosorbent assays (ELISA) for histidine-rich protein 2 (HRP 2) for Plasmodium falciparum (P. falciparum) detection.

This report presents findings from a review of the market landscape conducted from December 2013 to February 2014 as part of PATH’s Project DIAMETER (Diagnostics for Malaria Elimination Toward Eradication). To date, evaluation of malaria diagnostics markets has been relatively limited, and where it is available, it is largely focused on passive case detection and on higher-burden countries. This report aims to build on existing malaria diagnostics market work and to complement it by delving deeper into elimination and active use scenarios for malaria diagnostics.

The goal of Project DIAMETER (Diagnostics for Malaria Elimination Toward Eradication) is to define the diagnostic needs unique to malaria elimination settings with sufficient clarity so that all stakeholders can act with confidence to develop, commercialize, and efficiently implement the most promising, cost-effective, and impactful technologies for malaria elimination.Recent progress in malaria control has enabled countries to reduce malaria transmission rates. Existing diagnostic technologies—microscopy and rapid diagnostic tests (RDTs)—have played a critical role in this success by enabling many regions to achieve transmission rates near the threshold that defines the elimination phase. However, it is not clear whether these same tests are the most efficient and cost-effective tools to achieve accurate infection detection at low levels of parasitemia, which is critical to achieving elimination goals. Furthermore, there is a lack of clarity and agreement on the use scenarios, target product profiles (TPPs), standardized methods of assay validation, and market potential for the malaria diagnostic tools best suited for cost-effective detection in elimination settings. The resulting ambiguity hinders the development of new infection-detection technologies as well as strategic application of existing and nearly ready tools.PATH has developed a rigorous approach to identifying the most promising solutions to diagnostic challenges in low-resource settings. This involves aggregating and analyzing user needs, market needs, and technical requirements to generate the comprehensive evidence base necessary to inform product development, commercialization, and strategic program operations. Thus, through extensive field research and collaboration with malaria-elimination experts, the DIAMETER team will evaluate and hone the use scenarios and TPPs for infection detection in elimination settings. To this end, stakeholder interviews will be conducted in a selection of countries in Asia, Africa, and South America that are nearing malaria elimination. Information gathered will be collated to inform product development of new diagnostics and areas where further research is required. This report presents findings from stakeholder interviews conducted in China in September 2013.

Recent progress in malaria control has enabled countries to reduce malaria transmission rates. Existing diagnostic technologies—microscopy and rapid diagnostic tests (RDTs)—have played a critical role in this success by enabling many regions to achieve transmission rates near the threshold that defines the elimination phase. However, it is not clear whether these same tests are the most efficient and costeffective tools to achieve accurate infection detection at low levels of parasitemia, which is critical to achieving elimination goals. Furthermore, there is a lack of clarity and agreement on the use scenarios, target product profiles (TPPs), standardized methods of assay validation, and market potential for the malaria diagnostic tools best suited for cost-effective detection in elimination settings. The resulting ambiguity hinders the development of new infection detection technologies as well as strategic application of existing and nearly ready tools.PATH has developed a rigorous approach to identifying the most promising solutions to diagnostic challenges in low-resource settings. This involves aggregating and analyzing user needs, market needs, and technical requirements to generate the comprehensive evidence base necessary to inform product development, commercialization, and strategic program operations. Thus, through extensive field research and collaboration with malaria elimination experts, the DIAMETER team will evaluate and hone the use scenarios and TPPs for infection detection in elimination settings. To this end, stakeholder interviews will be conducted in six to eight countries in Asia, Africa, and South America nearing malaria elimination. This information will be collated to inform product development of new diagnostics and areas where further research is required. This report presents findings from stakeholder interviews conducted in Ethiopia in December 2013.

The goal of the Diagnostics for Malaria Elimination Toward Eradication (DIAMETER) project is to define the diagnostic needs unique to malaria-elimination settings with sufficient clarity so that all stakeholders can act with confidence to develop, commercialize, and efficiently implement the most promising, cost-effective, and impactful technologies for malaria elimination.Recent progress in malaria control has enabled countries to reduce malaria transmission rates. Existing diagnostic technologies—microscopy and rapid diagnostic tests (RDTs)—have played a critical role in this success by enabling many regions to achieve transmission rates near the threshold that defines the elimination phase. However, it is not clear whether these same tests are the most efficient and costeffective tools to achieve accurate infection detection at low levels of parasitemia which is critical to achieving elimination goals. Furthermore, there is a lack of clarity and agreement on the use scenarios, target product profiles (TPPs), standardized methods of assay validation, and market potential for the malaria diagnostic tools best suited for cost-effective detection in elimination settings. The resulting ambiguity hinders the development of new infection-detection technologies as well as strategic application of existing and nearly ready tools.PATH has developed a rigorous approach to identifying the most promising solutions to diagnostic challenges in low-resource settings. This involves aggregating and analyzing user needs, market needs, and technical requirements to generate the comprehensive evidence base necessary to inform program development, commercialization, and strategic program operations. Thus, through extensive field research and collaboration with malaria-elimination experts, the DIAMETER project team will evaluate and hone the use scenarios and TPPs for infection detection in elimination scenarios. To this end, stakeholder interviews will be conducted in a selection of countries in Asia, Africa, and South America that are nearing malaria elimination. Information gathered will be collated to inform product development of new diagnostics and areas where further research is required. This report presents findings from stakeholder interviews conducted in Zanzibar in May 2013.