GENEVA & TOKYO—While COVID-19 and the pandemic’s vaccine rollout remain center stage around the world, the Foundation for Innovative New Diagnostics (FIND), the Global Health Innovative Technology (GHIT) Fund, the Nagasaki University Institute of Tropical Medicine, and Leiden University Medical Center (LUMC) have partnered with Germany’s Merck KGaA to develop a rapid diagnostic test (RDT) for schistosomiasis, a neglected tropical disease that affects more than 220 million people.
The effort is supported by an investment of $3.5 million from the GHIT Fund, a Japan-based international public-private partnership fund between the government of Japan, multiple pharmaceutical companies, the Bill & Melinda Gates Foundation, Wellcome, and the United Nations Development Program.
This new collaboration will build on the prototype successfully completed by FIND, Mologic Ltd, LUMC, and Merck KGaA, and will accelerate the development and validation of an innovative RDT for Asian and African schistosomiasis and monitor treatment campaigns, programs, and evaluations.
Also known as snail fever or bilharzia, schistosomiasis is caused by infection with parasitic worms due to contact with parasite-infested water, according to Bumpei Tamamura, MPH senior director, Brand Communications at GHIT. The disease devastates whole communities, leading to organ damage, chronic ill health, and ultimately death—if left untreated. With more than 90 percent of cases in Africa, it is estimated that a further 700 million people could be at risk of infection.
The GHIT Fund “has focused on the investment in R&D for neglected diseases, where there are no market incentives,” Tamamura says. “Since its inception, we have believed the investment in neglected diseases is critical in the time of COVID, too, because the unmet medical needs for those neglected patients are still there, and the problems do not disappear—and even get worse.
“Secondly, a new point-of-care diagnostic is essential to contribute to the elimination of schistosomiasis and to achieve the World Health Organization’s 2030 NTD roadmap.”
Currently, field testing for schistosomiasis is time-consuming, relying on microscopic examination of stool or urine samples to detect parasite eggs, and sampling must typically be repeated over multiple days by trained microscopists, making it costly and challenging to deploy, Tamamura explains.
The RDT being developed by the collaborating partners will be based on a finger prick test to detect circulating levels of an antigen (CAA) that is secreted continuously by living schistosomes from various species—with sensitivity comparable to repeated microscopy, he tells DDN.
Tamamura adds that the test is subject to global access terms to ensure that it will be affordable and accessible in communities within endemic countries. It represents a critical asset toward reducing the global public health and economic burden caused by schistosomiasis, while paving the way to reach disease elimination by 2030.
The new test is being developed in collaboration with Mologic Ltd., which provides recombinant protein expression services for protein and antibody production and contract manufacturing for diagnostic devices. The project is expected to be completed by the end of 2022.
Catherine Ohura, CEO and executive director of GHIT, says, “Schistosomiasis affects hundreds of millions of people, and lack of diagnostic innovation is preventing treatment from reaching those who need it.”
The partners agree the time is now.
Kenji Hirayama, head of Secretariat at the Japan Alliance on Global Neglected Tropical Diseases, warns, “Schistosomiasis has spread to Africa, South America, China, and Southeast Asia, and although mass drug administration with praziquantel is in place, there is still a long way to go before it is eliminated.”
This project “is significant in reducing the time it takes to implement a comprehensive public health policy, including transmission, morbidity control, and surveillance,” Hirayama states. “We are proud to have researchers from Japan, which was the first country in the world to declare an end of endemic schistosomiasis in 1996, participating in this project.”
Béatrice Gréco, head of R&D and Access at the Merck Global Health Institute, says, “Merck remains committed to fight schistosomiasis until its elimination. To achieve this goal, it requires delivering integrated health solutions, including drugs and diagnostics to the communities in need.”
Within the scope of its schistosomiasis elimination program, Merck KGaA provides up to 250 million tablets of praziquantel annually to endemic countries free of charge, the company reports.
“New technology is urgently needed to get testing out of the laboratory and into the community so that we can ensure targeted use of the effective treatments we have available today. Effective, accessible RDTs are vital not just for patient care, but also for essential surveillance and disease tracking that can accelerate progress towards the elimination goals,” remarked Joseph Ndung’u, head of FIND Kenya and lead of the Neglected Tropical Diseases program.