The Foundation for Innovative New Diagnostics (FIND) announced today the launch of a new schistosomiasis program within its neglected tropical diseases (NTD) portfolio. The program focuses on developing rapid diagnostic tests (RDTs) for detection of circulating anodic antigen (CAA) in blood and/or urine, to support national control and/or elimination programs in countries where schistosomiasis is regularly found.
Schistosomiasis is caused by parasitic worms carried by freshwater snails and affects over 206 million people across 78 tropical and sub-tropical countries, with most of the burden found in sub-Saharan Africa. People can become infected when they come into contact with fresh water that is infested with worm larvae, while carrying out routine activities. The infection triggers immune reactions resulting in progressive organ damage, which can lead to chronic ill-health and ultimately death, if left untreated. Current World Health Organization (WHO) guidelines for schistosomiasis diagnosis recommend examination of stool and/or urine samples by microscopy to detect worm eggs, but this can be challenging especially when the intensity of the infection is low. Analysis of multiple samples over several days by highly trained microscopists is both time-consuming and challenging to deploy; inaccurate diagnosis can lead to treatment being stopped too soon and, as a result, infections quickly returning to their original levels.
CAA is secreted continuously by living schistosomes. A laboratory-based test for the antigen, with high sensitivity for all species of schistosomes that are of public health importance, is available. However, in order to achieve optimal sensitivity, the test requires complex sample processing steps and a reader for detection.
FIND is leading a consortium, together with WHO, that includes Mologic, UK, and Leiden University Medical Center (LUMC), Netherlands, to develop novel RDTs for schistosomiasis infection. Two RDTs for CAA are being developed: one to support ongoing schistosomiasis control programs by providing data to estimate prevalence and intensity of infection, supporting the update of guidelines on routine use of RDTs for schistosomiasis; the other one with a higher sensitivity to support elimination efforts by identifying low infection intensities.
Initial work streams are being supported by catalytic funding from the Bill & Melinda Gates Foundation, with additional funding from Merck, through the Merck Global Health Institute, which is amongst the scientific partners of this program. The science and technology company Merck launched its Global Health Institute in April 2017 with the mission to develop transformative health solutions to support control and elimination programs related to infectious diseases such as schistosomiasis, and to contribute to the United Nations Sustainable Development Goals (SDGs).
Schistosomiasis is contracted from contaminated water, putting whole communities at risk. The new diagnostic technologies will be a huge step forward, but to achieve real impact their use cannot be confined to labs. The RDT format will allow testing in community settings and enable essential surveillance and disease tracking.”
Joseph Ndung’u, Head of Neglected Tropical Diseases at FIND
Contributing to the schistosomiasis control and elimination agenda is a priority for Merck. This program clearly addresses the need for new sensitive diagnostics in the fight against schistosomiasis.”
Beatrice Greco, Head of R&D and Access at the Merck Global Health Institute
Seven out of the 10 diseases identified in the London Declaration for eradication, elimination or control by 2020 lack critical diagnostic solutions – including schistosomiasis. With this addition to our neglected tropical diseases program, we are pleased to extend our long-standing commitment of bringing diagnostic excellence to the fight against these diseases, contributing to WHO goals for control and, ultimately, elimination.”
Catharina Boehme, CEO, FIND
The program to develop the CAA RDTs is expected to be complete within 4 years, with the first milestone of feasibility testing for the disease control test anticipated in 2019.