Development of a point-of-care test for staging and follow-up of sleeping sickness gets a funding boost

Geneva, Switzerland – 30 August 2011 – FIND will expand its collaboration with Standard Diagnostics Inc. (SD, Republic of Korea) for the commercial development of a point-of-care test to identify the stages of sleeping sickness, also known as human African trypanosomiasis (HAT), and to track the effectiveness of treatment. Additional funding for this project was recently secured from the UBS Optimus Foundation. Other partners involved in the project include the Biomedical Proteomics Research Group at the University of Geneva (UNIGE, Switzerland), the Institute of Primate Research (IPR, Kenya) and the Institute of Tropical Neurology (ITN, France). This is the first time that the commercial development of such a test for HAT, which has the potential to change the way this neglected tropical disease is managed, has been attempted.

Today, HAT patients, including children, have to undergo a painful and invasive lumbar puncture to determine if the brain is involved, referred to as staging, before treatment of sleeping sickness can be initiated. Patients often dread this procedure, which can be hazardous when performed in field conditions. In addition, after treatment and during the post-treatment period, the lumbar puncture must be repeated every six months for two years to confirm cure.

FIND partners, led by scientists at the UNIGE, have identified and validated unique molecules that could be used to determine the stage of the disease in a large multi-centric African cohort. The concentration of these molecules falls quickly in the body of patients whose treatment is successful. “In cases where the molecules remain detectable or reappear after treatment, this indicates that the patient has not been cured”, states Jean-Charles Sanchez, principal investigator of the study consortium. “Although we have recently made significant progress towards improving diagnosis of HAT, treated patients are usually unwilling to come back for follow-up for fear of the lumbar puncture. We, therefore, aim to eliminate this problem by discovering blood markers of the late-stage disease using proteomics”.

This staging test, which will take the form of an inexpensive lateral flow test used for the first time with cerebrospinal fluid, will complement a new screening tool, also under development by FIND and SD, that is simple to use by community health workers and is currently undergoing clinical trials in Angola, Central African Republic and the Democratic Republic of Congo (DRC). These tests will not require any instrumentation, only a finger prick for blood, and will, therefore, be easy to use in health centres where staging, treatment and follow-up are routinely performed. The combination of both tests will significantly increase the chances of survival and recovery after the patients are appropriately treated.“We are excited about the continued progress in the development of a variety of tests suited to rural settings, which will have a significant impact on the management of neglected diseases such as HAT,” says Dr. Giorgio Roscigno, FIND CEO. “Our ultimate goal remains the development of a test that will eliminate the need for a lumbar puncture, and we are redoubling efforts to achieve this.”

The grant will also explore the feasibility of using loop-mediated isothermal amplification (LAMP) of DNA as a test of cure. The LAMP test for HAT is a simple DNA amplification method developed in collaboration with Eiken Chemical Co. (Japan), which is undergoing evaluation in Uganda and the DRC. If the research with HAT patients replicates animal model results, LAMP testing of serum might obviate the need for lumbar punctures. The ability to confirm cure in less than 12 months after treatment would have positive implications on the management of the disease. Fewer patients would be lost to follow-up, and uncured patients requiring re-treatment would be detected early before they develop irreversible damage to the central nervous system.

Taken together, the rapid community-level screening test, the rapid community-level staging test, and the LAMP confirmatory test-of-cure, have the potential to dramatically alter the way in which HAT is managed today.

Media contacts:
FIND: media@finddx.org
UNIGE:Jean-Charles Sanchez
IPR:Maina Ngotho
ITN:Sylvie Bisser

About human African trypanosomiasis, HAT

FIND is dedicated to developing affordable, easy-to-use and cutting edge diagnostic tests that save lives in the poorest areas of the world. The organization works with multiple and diverse groups, from academia, industry, donors, partners in the field, Ministries of Health and the World Health Organization. With five new diagnostic tools for TB already in use, FIND also has established programmes in malaria and sleeping sickness, and has begun working on other neglected diseases such as leishmaniasis. Launched in 2003, the not-for-profit international organization is ISO certified and financed by both the private and public sectors, including the Bill & Melinda Gates Foundation, Government of the Netherlands, the European Union, UNITAID, UK Department for International Development, National Institutes of Health (USA) and others.

Standard Diagnostics Inc., based in the Republic of Korea, has become a global leader in the development of in-vitro diagnostics, with a special focus on point-of-care tests. Their aim is to develop diagnostic systems for early detection of infectious diseases. SD supplies the company’s flagship products, which include immunochromatographic rapid test kits, which are available through 160 distributors in more than 100 countries for point-of-care testing of infectious diseases, blood-borne pathogens, tumor and cardiac markers, as well as hormones. All SD products are manufactured in-house under strict quality control as per international standards (ISO 13485:2003, CE, U.S. FDA). SD’s mission is to continuously provide top quality products to their customers worldwide at competitive prices.

Institute of Primate Research (IPR), in Nairobi, Kenya, is a semi-autonomous directorate of the National Museums of Kenya (NMK). In 2009, it was certified ISO:9001 2008 compliant. IPR is an internationally recognized centre of excellence for biomedical research and a WHO collaborating centre for reproductive health and infectious tropical diseases. IPR has a scientific and ethical review mechanism through the Institutional Review Committee (IRC). It has good laboratory practice and WHO accredited trainers who ensure continuous improvement in the way research is conducted to optimize resources and obtain data that is reproducible, reliable and acceptable. IPR has primate models for leishmaniasis, HAT, malaria, schistosomiasis, and simian-human immunodeficiency virus (SHIV). Its location in a disease endemic country allows the use of pathogens as they occur in humans.

The Biomedical Proteomics Research Group (BPRG) at the Faculty of Medicine, University of Geneva (UNIGE), has had a world-leading role in proteomics since 1984. BPRG researchers work in the complementary areas of protein separation, detection and identification methods and their related computer sciences field. As a co-inventor of the proteome concept in 1994, BPRG has demonstrated the great impact proteomics could have in biomarker discovery, permitting the development of new diagnostic, therapeutic and predictive tools. The University of Geneva is one of the top 12 research universities in Europe and since 2002 is a member of the League of European Research-intensive Universities. Many international rating bodies have ranked it as a leader in scientific research, in particular in the fields of molecular biology, astrophysics, social sciences and economics.

The Institute of Tropical Neurology (ITN) in Limoges, France was established in 1981 and is associated with the University of Limoges. The institution’s aim is to promote research, training and medical actions in neuro-epidemiology and tropical neurology. The institute is part of a network of partners from southern countries (Africa, Asia) collaborating primarily with Universities, and especially with neurologists. Main research actions are focused on epidemiological studies in epilepsy and dementia, and on parasitic diseases with neurological involvement, mainly sleeping sickness and toxoplasmosis.

The UBS Optimus Foundation supports innovative, needs-based approaches and projects aimed at advancing the protection, education and health of children in need. As an independent grant-making foundation established by UBS in 1999, the Foundation engages in a professional and transparent strategy that ensures optimal use of donations to generate lasting impact. Within its health-related funding portfolio, UBSOF focuses on research projects that aim to harness innovation, whether it be new tools (such as diagnostics, vaccines or medicines) or new approaches (such as trans-disciplinary efforts to encourage researchers across different disciplines to work with each other outside of their usual practice) — all with the goal of improving health outcomes for children. Thanks to UBS covering all administrative and wage costs, 100% of every contribution goes to the supported projects. Contributions from over 10,500 donors have enabled UBS Optimus Foundation to provide 100 million Swiss francs in support to 211 projects in 65 countries over the last 10 years.