FDA Approves the SMART Leish PCR assay for Diagnosing Leishmania in Individuals with Signs and Symptoms of Leishmaniasis

The U.S. Food and Drug Administration cleared the SMART Leish PCR assay, a test to aid in the diagnosis of individuals with cutaneous leishmaniasis, for marketing.

The U.S. Army Medical Research and Materiel Command worked for several years to develop the SMART Leish diagnostic test to address the global health issue of cutaneous leishmaniasis. This disease has occurred in thousands of U.S. troops serving overseas in Iraq and Afghanistan during Operations Iraqi Freedom and Enduring Freedom. The SMART Leish PCR assay was a partnership between the Walter Reed Army Institute of Research, the U.S. Army Medical Materiel Development Activity and the commercial partner, Cepheid USA, Inc.

Leishmaniasis is a parasitic disease endemic throughout Africa, Asia, Europe, and North and South America. Leishmaniasis is caused by single-cell organisms transmitted by the bite of small insects called sandflies. Cutaneous leishmaniasis is the most common form of the disease. Although 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 cutaneous leishmaniasis. Traditional testing methods require a small tissue sample of the skin ulcer lesion. These samples are examined by microscopy 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 (staining-microscopy) to four weeks (cultures) 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, Division of Entomology at WRAIR.

"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, Director of the Division of Experimental Therapeutics at WRAIR.

"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." According to Hochberg, this assay represents the first FDA cleared Real Time PCR diagnostic device for infectious diseases developed and cleared by the Department of the Army.

WRAIR developed the intellectual property for this assay and licensed it to Cepheid, USA. The Smart Cycler and the primers and probes for the SMART Leish real-time PCR are manufactured for the assay by Cepheid USA, Inc.

According to Louis Jasper, product manager at USAMMDA, USAMMDA played two roles in helping to forward the development of the assay, serving as the sponsor's representative for the Office of The Surgeon General of the Army and the advanced development program management office.

"The USAMMDA Division of Regulated Activities and Compliance provided regulatory oversight and guidance throughout the product development effort. Most significantly, DRAC effectively managed FDA interactions; leading to the clearance of this assay," said Jasper.

In coordination with the MRMC Integrated Product Team and commercial partner, the Pharmaceutical Systems Project Management Office provided funding and leadership to mature the SMART Leish PCR assay from the technology base through advanced development.

Additional information about leishmaniasis is available at the Centers for Disease Control and Prevention website at http://www.cdc.gov/parasites/leishmaniasis/.

By Carey Phillips, USAMMDA Public Affairs