Neglected tropical diseases (NTDs) caused by bacteria, viruses, worms, and other parasites afflict 1.4 billion of the world’s poorest people, trapping them in a cycle of poor health, disability, and poverty. The World Health Organization (WHO) has targeted a group of these diseases for control, elimination, or eradication, and many institutions that support global health and international development, including PATH, have joined the effort. A pressing need for programs addressing NTDs is the availability of high-quality, low-cost diagnostic tools deployable in low-resource settings. Tools that enable rapid and accurate detection of these diseases will become increasingly important for monitoring progress as levels of infection are reduced through disease-control efforts. Appropriate diagnostic tools also are needed to conduct surveillance for disease reemergence after presumed elimination.

PATH’s Diagnostics Program works to identify and develop innovative, high-impact, low-cost diagnostic tools to meet the needs of users in low-resource settings. We are working with a broad range of partners—industry, end-users, academic researchers, nongovernmental development organizations, national NTD programs, policymakers, and donors worldwide— to identify areas where the introduction and scale-up of new diagnostic tools for NTDs will have the greatest impact, to evaluate potential technologies, and to focus on the most promising solutions.

A crucial early step in the research and design phase of product development for diagnostic tools is defining their essential features, so that researchers and manufacturers can develop the best solutions. This is the purpose of a target product profile (TPP)—a strategic document that defines key characteristics of a product. TPPs must contain sufficient detail to allow developers to understand the attributes a successful tool must have—not only the technical requirements, but also those that allow its use in a defined setting. A TPP includes descriptions of design features, the types of specimens needed for diagnostic measurements, and performance characteristics such as clinical sensitivity and specificity.

PATH has constructed TPPs for diagnostic tools for three NTDs—schistosomiasis, soil-transmitted helminthiasis (STH), and blinding trachoma. We began this process with a review of the scientific literature and progressed through discussions with experts and other members of the NTD community, assessment of current technologies, mapping of in-country surveillance programs, and identification of biological markers and platforms. Each TPP was refined through an iterative process, with rounds of research, review by experts, and revision until consensus was reached. This report highlights the process used to construct these TPPs, as well as includes summary tables compiled from the original TPPs as an example.