FIND and Standard Diagnostics to collaborate on a point-of-care test for leishmaniasis

Geneva, Switzerland – 16  April 2014 – FIND and Standard Diagnostics (SD) Inc. of the Republic of Korea, have signed an agreement to work on a point of care rapid diagnostic test (RDT) for visceral leishmaniasis (VL or kala-azar), a disease caused by the protozoan parasite Leishmania (L.) donovani in the Old World and L. infantum in both the Old and New Worlds.

Visceral leishmaniasis is the most severe form of leishmaniasis and is 100% fatal if left untreated. Rapid and accurate diagnosis is the first essential step towards effective treatment and control of VL. Today, serological tests that detect host antibodies to the parasite offer a simple solution for diagnosis of the disease at the community level. However, because host antibodies tend to remain in the blood for long periods after patients have been cured, such tests cannot distinguish between current and past infections. An antigen detection test would, therefore, provide more accurate means for diagnosis since a positive result would indicate the presence of the infecting parasites. Such a test could also be used to monitor the effectiveness of treatment.

The FIND and SD agreement follows the successful completion of three years of research that has resulted in the development of an ELISA assay for Leishmania antigens in urine. The project has been in collaboration with Drugs for Neglected Diseases initiative (DNDi), Institute Pasteur (France), Kalon Biologicals Ltd. (United Kingdom), Kenya Medical Research Institute (KEMRI) and International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b). Unlike previous tests, the ELISA assay detects Leishmania antigens in urine without the need to boil samples. Very promising results were obtained when the assay was used to test samples collected in Bangladesh and East Africa and is now under evaluation by independent partners. Development of an RDT, which would be more suitable for use in settings where the disease occurs, promises to bring much-needed improvement to the diagnosis of leishmaniasis.

Under the new arrangement, FIND will facilitate access to reagents needed for the test, studies in development, evaluation and demonstration of the new test, as well as access to urine samples. Standard Diagnostics Inc. will develop, market and distribute the test under terms that guarantee its widespread use.

About FIND
The Foundation for Innovative New Diagnostics is dedicated to developing affordable, easy-to-use, cutting edge diagnostic tests that save lives in the poorest areas of the world. From proof of principle to putting new tests into practice, the organization works with diverse groups, including academia, industry, donors, partners in the field, Ministries of Health and the World Health Organization. With new diagnostics for malaria, tuberculosis and sleeping sickness already in the field, FIND is also working on other neglected diseases such as leishmaniasis, Chagas disease, and Buruli ulcer. Created in 2003, the not-for-profit Foundation is ISO certified and financed by both the private and public sectors, including the Bill & Melinda Gates Foundation, the governments of the United Kingdom (DFID), Switzerland (SDC), the Netherlands, Germany (BMBF/KfW), the United States (CDC, NIH and USAID) and Australia (AusAID), the European Union, UNITAID, The Global Fund to Fight AIDS, Tuberculosis and Malaria, UBS Optimus Foundation and others.