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Improved diagnosis of visceral leishmaniasis in humans and cutaneous leishmaniasis in dogs

Organization name

TransMIT Gesellschaft für Technologietransfer mbH


Product description

To date, the diagnosis of the severe infectious disease leishmaniosis is still highly unreliable in endemic areas of Eastern Africa, since the pathogen occurring in these regions differs from pathogens present in other endemic areas of South Africa and Asia. Moreover, leishmaniasis is also spreading in southern Europe because infected dogs represent a major source of risk for the transmission to humans.

A cost-effective and time-efficient diagnostic was developed which provides a more reliable diagnosis of leishmaniasis in humans and animals as compared to currently available diagnostics. This diagnostics is particularly suitable for a use as rapid test, allowing an uncomplicated application outside of clinics and laboratories and consequently a more efficient and improved diagnosis of leishmaniasis in hospitals and in the field.

Despite of approximately 500.000 newly diagnosed cases each year, visceral leishmaniasis counts among the most neglected infectious diseases which can cause death if left untreated. Affected by this disease are in particular inhabitants of developing countries, but the infection slowly also spreads across Southern Europe. In Sudan, the most seriously affected region, to date no reliable rapid test for visceral leishmaniasis and thus no reliable diagnosis exists. Leishmaniasis is however not only widespread in Northeast Africa, but also world-wide in tropical and sub-tropical climates with the exception of Australia. Affected are in addition to humans also dogs which, amongst others due to imports, spread infections as far as the northern regions of Europe and the USA.
Leishmaniasis is endemic in 98 countries and causes an estimated 1.5 millions of cutaneous and 0.5 millions of visceral new infections annually. Leishmanias are transmitted by the sting of the sand fly or moth fly, but also via blood transfusions or small injuries of the skin which pose a large risk of disease transmission in case of contact with infected dogs. Leishmaniasis is a zoonosis, an infectious disease which is transmissible from animals to humans.

State of the Art

The diagnosis of visceral leishmaniasis involves in most cases invasive procedures which can only be carried out in hospitals or is performed with tests requiring time consuming laboratory diagnostics. In addition to the high time and cost expenditure is this diagnostic procedure unsuitable for field applications or a large numbers of patients.

Currently available rapid tests based on an antibody reaction against Leishmania chagasi are unfortunately not able to reliably detect the visceral leishmaniasis in Sudan which is caused by the pathogen L. donovani. A further disadvantage of
currently available tests is the less sensitive diagnosis of asymptomatically infected patients. A rapid diagnosis with conventional tests in Sudan is therefore only possible to a very limited extent.

Dogs are furthermore often infected without any detectable symptoms, i.e. infected dogs may be lifelong carriers of the pathogen and are thus also potential transmitters of the disease to humans.

Unique selling points and state of product development

Developed was a diagnostic procedure which allows an improved rapid diagnosis (sensitivity and specificity) of visceral leishmaniasis in Eastern Africa. Investigations furthermore demonstrated that the newly developed test provides the same or even higher sensitivity and specificity as compared to conventional tests in endemic regions of South America and Asia. Of major epidemiologic importance is also the property that this test is able to reliably diagnose also asymptomatically infected dogs.

Patent status

A European patent application was filed on January 18, 2013.

Possibility / desire for cooperation

TransMIT is looking both for cooperation partners for the further development of the invention up to routine application and for distribution and production partners.

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