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New Diagnostic Test for Leprosy Being Developed

By September 24, 2018No Comments

Before an infectious disease can be treated, it must be detected. Key attributes of successful diagnostic tests include speed and cost, but it is also critical that they are easy to administer – particularly in remote areas that do not have ready access to labs or health care facilities. HDT Biotech Corporation ( is teaming with IDRI (, both of Seattle, WA, to develop a cost-effective test with enhanced sensitivity for detecting infection with M. leprae, the bacterium that causes leprosy. Funding for test development is being provided by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, under Contract No. HHSN272201800019C.

Characterized by the World Health Organization as a “neglected tropical disease,” leprosy (also known as Hansen’s disease) is caused by Mycobacterium leprae infection. The mycobacterium is capable of causing disfiguration as well as progressive and irreversible nerve damage. The goal of the funded development stage is to optimize production of a defined recombinant antigen and evaluate it, in conjunction with IDRI formulations, for its ability to detect an M. leprae-specific response when inoculated into the skin.

“This project combines expertise in formulations technology with our experience with leprosy,” said Malcolm Duthie, PhD, Vice President of Research at HDT. “We aim to develop a test for leprosy that is similar to the PPD skin test that is currently used for tuberculosis. A test of this nature will be easy to use for mass screening and can be used for early diagnosis of leprosy.”

If successful in this phase I study, next steps will include evaluation of the prioritized formulation with specialized intradermal inoculation devices before distribution to a network of collaborators for field evaluation in various M. leprae-endemic regions. “For the first time, it will be possible to have a safe and effective test for early detection of infection with the leprosy bacillus in the places where it is needed most,” said Steve Reed, PhD, IDRI President, CEO and Founder of HDT. “IDRI has a long and successful history of developing diagnostic tools for neglected diseases. Several of these tests are in use to save lives on a daily basis. We hope this project will provide a breakthrough that allows for specific detection of M. leprae infection at very early stages, ultimately allowing intervention to stop progression to disease.”