FIND and Standard Diagnostics Inc. parnter to co-develop and supply a point-of-care test for sleeping sickness

Geneva, Switzerland – 23 February 2010 – A landmark agreement between FIND and Standard Diagnostics (SD) Inc. in the Republic of Korea will result in commercial development of a point-of-care (POC) rapid diagnostic test for sleeping sickness, also known as human African trypanosomiasis (HAT). This follows the successful completion of three years of research by FIND and partners that has resulted in the identification of a set of probes which, when used alone or in combination, can accurately detect cases of the disease. Under the new arrangement, FIND will provide SD with data generated during the screening process, and facilitate the evaluation, registration and demonstration of the new test. FIND will also facilitate access to antigens for phase 1 of the development, and to serum samples from the WHO Specimen Bank. Standard Diagnostics Inc., on their part, will develop, market and distribute the test under terms that guarantee its sustainable access at costs that are lower than existing tests.

“We are very excited about this collaboration,” said Dr. Giorgio Roscigno, FIND CEO, “since it comes as a coronation of FIND’s investment and commitment to the development, over three years, of an antibody test.”

Sleeping sickness is a deadly, neglected tropical disease that affects impoverished rural communities in sub-Saharan Africa. There are no clinical signs that are characteristic of the disease, which makes it difficult to diagnose, and if infected people are not treated, they eventually die. Yet when an early and accurate diagnosis is made, treatment is safe and relatively inexpensive. The disease unfortunately progresses from an early or stage 1 disease to a devastating 2nd or late stage form associated with damage to the central nervous system. During this 2nd stage, patients display a range of psychotic signs that lead to stigmatization by their families and communities. The few drugs that are used to treat patients in this stage are administered over prolonged periods of hospitalization, and are associated with potentially fatal adverse reactions.

FIND has been working with partners to develop diagnostic tests for HAT that are cheap, easy to use, sensitive and specific enough to accurately detect cases when they are in stage 1 disease. Others include tests to determine the stage of disease, tests to confirm cure after treatment, and to detect relapses after a failed treatment. The test to be developed by SD will be in a lateral flow format, which will be easy to use in health posts and in screening programmes (Figure 2).

Over the years, fundamental research on trypanosomes, the parasites that cause HAT, has described many parasite-specific proteins with diagnostic potential, but only minor attempts have been made to convert them into diagnostic formats. The strategy FIND adopted was to select candidate antigens amongst those that are currently available. Scientists and laboratories with such antigens have been collaborating with FIND in screening native, recombinant and synthetic peptides for their potential in diagnosis of T.b. gambiense and T.b. rhodesiense, the two forms of sleeping sickness. The laboratories that provided antigens included, among others, the University of Texas Southwestern Medical Center at Dallas (US), the Research Unit for Tropical Diseases, de Duve Institute, and Laboratory of Biochemistry, Université catholique de Louvain (Brussels, Belgium), Laboratoire de Génomique Fonctionnelle des Trypanosomatides (Bordeaux, France), the Institute of Tropical Medicine (ITM – Belgium), the University of Cambridge (UK), the Biochemical Proteomics Research Group (BPRG, University of Geneva, Switzerland), the International Livestock Research Institute (ILRI, Kenya), University of Dundee (Scotland) and the Wellcome Trust Centre for Molecular Parasitology, University of Glasgow (Scotland).

In order to identify the most promising candidates, an initial panel of 32 different antigens was screened in a dot blot assay by Microcoat in Germany, using a collection of well-defined sera from patients infected with T.b. gambiense and T.b. rhodesiense. The first screen led to selection of 13 antigens, which underwent two more rounds of screening using dot blot and ELISA, and new collections of positive and negative serum samples, with greater emphasis on specificity. The final round of screening has been completed and selection of the antigens for the POC test will be done during the first phase of development by SD, to be completed before the end of 2010. The positive and negative human serum used for the screens was donated by, among others, the National Livestock Resources Research Institute (NaLIRRI – Uganda), ITM (Belgium) and the WHO Specimen Bank.

The primary target of the new partnership is a POC test that will be broad enough to detect patients infected with either T.b. gambiense or T.b. rhodesiense. The test will not require any instruments, allowing its introduction into the lowest level of the health service, hence making integration of HAT diagnosis in the public health sector of endemic countries a realistic goal. A spin-off could be another test that can be used in the diagnosis of livestock trypanosomiasis, which causes annual losses of up to 4.75 billion US dollars to African agriculture.

“Our target is to complete the development of a rapid diagnostic test for HAT in six months,” said Dr. Young-Shik Cho, SD CEO. “It should be simple and accurate enough to be used for screening purposes in remote settings.”

The POC test to be developed by SD will not replace loop-mediated isothermal amplification (LAMP) of DNA, a molecular test for HAT that has completed Phase 1 development by FIND and Eiken Chemical Co. in Japan. The LAMP test is intended for case detection and as a test of cure, and since it requires a heating block to perform, will be positioned at the microscopy level of the health service, further supplementing diagnosis of this devastating disease.

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FIND is a non-profit organization established in 2003, and is based in Switzerland with offices in Uganda and India. Its mission is to develop, evaluate, demonstrate, and accelerate the implementation of new diagnostic tests and platforms for diseases of poverty, including TB, malaria, and HAT. Increasingly, FIND’s approach to diagnostics development is targeted at technological platforms that can address diagnostic needs across disease areas, and that can also be implemented at levels of the health care system, closer to where patients first seek care. FIND has active collaborations with over 100 partners, including research institutes/academia, Ministries of Health, commercial partners, bilateral and multilateral organizations, especially WHO, and clinical trial sites.

Standard Diagnostics Inc., based in the Republic of Korea, has over ten years’ experience in the development of early diagnostic systems for the early detection of infectious diseases. SD has become a global leader in the development of in-vitro diagnostics, with a special focus on point-of-care tests and supplies the company’s flagship products, which include ICA rapid test kits for point-of-care testing of infectious diseases, blood-borne pathogens, tumor and cardiac markers, as well as hormones. Their products are made available through 160 distributors in more than 100 countries. 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 at competitive prices to its customers worldwide.

Microcoat GmbH, located in Bernried, Germany, is active in the field of immune- and nucleic acid diagnostics, with more than 20 years’ experience in solid-phase chemistry. The product portfolio includes coated microplates, functionalized biosensor surfaces, bulk reagents and diagnostic kits. R&D activities are focused on new parameters and test principles, as well as the development of assay components. Additionally, the company offers a portfolio of services, such as the development of specific assays, the validation of diagnostic instruments and sample measurement within therapeutic and diagnostic studies. MicroCoat maintains a certified Quality Management System to ensure that its products and laboratory services meet the quality standards of customers and regulatory authorities. The company is certified according to DIN EN ISO 13485/9001. MicroCoat offers services for preclinical and clinical studies which are conducted in compliance with the OECD Principles of Good Laboratory Practices (GLP).