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FDA Approves Test for Diagnosing Leishmaniasis Caused by Sand Flies

The U.S. Food and Drug Administration cleared the way for the SMART Leish PCR assay, a test to aid in the diagnosis of individuals with cutaneous leishmaniasis caused by certain species of sand flies. The Army Medical Research and Materiel Command worked for several years to develop the diagnostic test to address the global health issue of cutaneous leishmaniasis, which has occurred in thousands of U.S. troops serving in Iraq and Afghanistan.

The SMART Leish PCR assay was developed in partnership among Walter Reed Army Institute of Research, or WRAIR, Army Medical Materiel Development Activity and the commercial partner, Cepheid USA, Inc.

Endemic throughout Africa, Asia, Europe as well as the Americas, leishmaniasis is a protozoan parasitic disease caused by single-cell organisms transmitted through the bite of a sand fly. Cutaneous leishmaniasis is the most common form of the disease. Though not considered life threatening, the disease can cause disfiguring skin ulcers that take months to heal and cause scarring. Up to this point there were no FDA cleared devices for the diagnosis of the disease. Traditional testing methods require a small tissue sample of the skin ulcer lesion. The samples are examined under microscope and culture to determine the presence of the intracellular form of the leishmania parasites called amastigotes. These traditional testing methods can require anywhere from 30 minutes to four weeks to produce results. In contrast, the SMART Leish PCR is a qualitative test that uses real-time Polymerase Chain Reaction to amplify DNA sequences unique to the organism that causes cutaneous leishmaniasis. Samples are acquired from skin lesions in the same way they are acquired for traditional methods.

“The Smart Leish Real-Time PCR assay can provide consistent results within hours of sample receipt, even when the numbers of parasites in the skin are so low that microscopy and culture results will be negative at day 30. This allows for timely treatment of the disease,” said Lisa Hochberg from WRAIR's division of entomology. “Servicemembers will immediately benefit from this new assay since the Smart Leish Real-Time PCR will be part of the battery of tests run at the Leishmania Diagnostic Laboratory, Division of Experimental Therapeutics at WRAIR,” said Col. Max Grogl, the director there. “In the near future, this assay may be utilized at additional strategically located DoD medical facilities, enhancing our capability to provide rapid diagnosis to servicemembers and improve patient management,” said Grogl.

According to Hochberg, this assay represents the first FDA-cleared real time PCR diagnostic device for infectious diseases developed and cleared by the Army.

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