CL diagnostic tool gets FDA clearance

The U.S. Food and Drug Administration has approved a device that will provide rapid diagnosis of cutaneous leishmaniasis (CL), the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) announced on Nov. 14.

USAMRIID partnered with InBios International Inc., the Institut de Tunis in Tunisia, Walter Reed Army Institute of Research and the Army's Small Business Innovation Research Program (USAMRMC SBIR) to create and manufacture the CL Detect system. The new device can have accurate results within 30 minutes, allowing for quicker treatment in the case of infection.

CL is a parasite infection that can cause disfiguring lesions if not treated quickly. It largely affects the tropical and sub-tropic areas in the Middle East, sub-Saharan Africa, Mexico, southwest Asia, and Central and South America.

There are an average of 1.5 million new infections annually, USAMRIID said. The parasite is transferred from infected sand flies and puts military personnel at risk.

The project is an example of smaller businesses and military partnerships coming to fruition.

"Dedicated product managers drive transformational results by partnering with small businesses," JR Myers, project manager for USAMRMC SBIR, said. "This project is a great example of the cutting-edge impact small business innovators can bring to military health through the U.S. Army SBIR Program."

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U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)

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