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FDA OKs Army's Diagnostic Tool for Skin Disease

Army scientists at Fort Detrick are hailing the Food and Drug Administration's approval of a tool they helped develop for rapidly diagnosing a disfiguring skin disease caused by sand fly bites in the Middle East.

The U.S. Army Medical Research and Materiel Command said Friday that the hand-held dipstick can produce results within 30 minutes. The previous method depended on laboratory tests of skin-lesion samples that often had to be shipped to the United States.

Lt. Col. Jeanne Norwood says rapid diagnosis means quicker treatment for the disease, called cutaneous leishmaniasis.

Leishmaniasis is a parasitic disease that is found in parts of the tropics, subtropics, and southern Europe. It is classified as a Neglected Tropical Disease (NTD). Leishmaniasis is caused by infection with Leishmania parasites, which are spread by the bite of phlebotomine sand flies. There are several different forms of leishmaniasis in people. The most common forms are cutaneous leishmaniasis, which causes skin sores, and visceral leishmaniasis, which affects several internal organs (usually spleen, liver, and bone marrow).

The Army says the disease affects millions worldwide, including U.S. service members. The World Health Organization reported a major outbreak in Afghanistan in 2010.

The device is made by Seattle-based InBios International Inc.

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