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Chagas disease is a neglected tropical disease caused by the protozoan Trypanosoma cruzi and spread through the triatomine bug. The World Health Organization estimates that nearly six million people are infected with T. cruzi in Latin American and seventy million people are at risk of infection, which can cause cardiac and intestinal complications. If untreated, infection is lifelong and can be life threatening. Morbidity and mortality from Chagas disease is a critical health problem affecting poor communities throughout Latin America.The WHO has put forward goals for the interruption of transmission in the home (Latin America) and through blood transfusions (Latin America, Europe, and Western Pacific) by 2015, as well as the elimination of Chagas-carrying insects near homes in Latin America by 2020. The London Declaration on NTDs backed these goals with commitments from public and private institutions. However, according to the London Declaration 3rd Report, more concerted efforts to improve access to diagnosis and treatment are needed to achieve these goals.PATH aims to catalyze engagement of the diagnostics industry and product development efforts in support of the London Declaration goals. As part of this work, PATH examined the Chagas diagnostics landscape to identify gaps in availability, accessibility, and use of appropriate diagnostic tools for Chagas. We conducted literature reviews and interviews with key stakeholders to identify use cases for Chagas diagnostics, understand current practices, and assess progress toward more robust diagnostics. The findings were used to analyze the current diagnostic landscape for Chagas and highlight current needs to improve access to diagnostics for prioritized use cases.PATH identified four use cases for Chagas diagnostics: case diagnosis, congenital case detection, treatment monitoring, and screening of blood and organ donations. Our analysis found that access to and adoption of current tools remain a barrier to their effective use in Chagas disease control efforts in many endemic settings. This may be due in part to insufficient evidence to support their implementation. Additionally, because of the reliance on serologic tests and inadequate markers of active infection, current tools available to detect congenital infections and monitor treatment are not yet sufficient to fully support needs in these use cases. Based on these findings, we offer the following recommendations:Establish more standardized policies and practices for Chagas diagnosis and treatment by generating evidence around the efficacy of current tools in diverse settings and building consensus around standards among global and regional stakeholders.Develop a point-of-care diagnostic tool to detect congenital infections, which would enable early initiation of treatment and a clear linkage to postnatal care.Develop a diagnostic tool to monitor treatment efficacy, which would inform clinical decision-making during treatment and support the development of better drugs.

Visceral leishmaniasis (VL) is a deadly disease caused by infection with the Leishmania parasite. The majority of cases are found in South Asia, east Africa, and Brazil. As many as 310 million people are at risk of infection, and it is estimated that between 20,000 and 50,000 deaths result from VL annually. VL is spread through the bite of the sandfly vector, and it can be harbored by human and canine reservoirs. The parasite causes nonspecific symptoms such as fever and splenomegaly; if left untreated, VL typicallyleads to death.The World Health Organization (WHO) 2020 goal is to eliminate VL from the Indian subcontinent (i.e., achieve prevalence of less than 1 case per 100,000). The WHO set a number of goals for the Neglected Tropical Diseases (NTD) to be achieved by 2020, and the London Declaration on NTDs backed these goals with commitments from public and private institutions. The 3rd progress report of the London Declaration indicated that “priorities for progress” towards reaching VL goals include early detection of cases, improved access to diagnosis, and scale-up of diagnostic services.In support of the London Declaration goals, PATH aims to catalyze engagement of the diagnostics industry and product development efforts. As part of this work, PATH assessed needs and landscaped potential solutions to improve diagnostic tools used to support VL elimination efforts. We conducted literature reviews, a product development landscape, and interviews with key stakeholders to identify gaps in current human VL diagnostics as well as emerging solutions. These findings were used to identify use cases for VL diagnostics, determine which tools address specific use cases, analyze progress toward robust diagnostics in the development pipeline, and ultimately to propose recommendations on how to improve availability, access, and adoption of VL diagnostics.PATH identified four use cases for human VL diagnostics: diagnosing acute infection, diagnosing VLHIV coinfection, diagnosing post-kala-azar dermal leishmaniasis (PKDL), and treatment monitoring. We found that current tools and methods are likely sufficient for the early case detection needed to support elimination goals. However, current rapid diagnostic tests (RDTs) have limitations and new tools would benefit patients with HIV coinfection and PKDL, as well as improve treatment monitoring. We have developed the following recommendations:Support ongoing efforts to ensure full access to, and adoption of, current antibody detection RDTs. Health systems and market research may be needed to support optimal uptake of currently available antibody tests.Develop an antigen detection test to better diagnose VL-HIV coinfection and monitor treatment. There is a need for a noninvasive, field-friendly test that can identify active VL infections among HIV coinfected patients, as well as monitor for treatment failure and relapse.Support research and development needed for next generation antibody detection RDTs. A noninvasive, sensitive rapid test is needed to enable treatment monitoring and detection of PKDL.

PATH’s Center for Malaria Control and Elimination is building on our unparalleled portfolio of malaria tools and projects, encompassing a broad collection of competencies and expertise, to advance efforts toward elimination, and ultimately eradication, of both P. falciparum and P. vivax malaria.

PATH, in collaboration with the Directorate General Health Services (DGHS), Directorate General Drug Administration (DGDA), Government of Bangladesh (GoB) and International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), is implementing a focused pharmacovigilance program for kala-azar, or visceral leishmaniasis (VL), in Bangladesh. The program aims to strengthen patient safety and care associated with the use of VL drugs. The results of the pharmacovigilance activities are summarized in this newsletter.

Investments in the health and well-being of girls and women yield exponential gains, improving their lives as well as the productivity and prosperity of families, communities, and future generations. PATH works to place girls’ and women’s health and rights at the top of global and national development agendas—including how we achieve the Sustainable Development Goals.