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FDA Approves Leishmaniasis PCR Test Developed by US Army, Cepheid

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This article has been updated from a previous version to clarify information about the cause of leishmaniasis.

The US Food and Drug Administration has approved the Smart Leish PCR assay, a qualitative real-time PCR test for diagnosing individuals with cutaneous leishmaniasis, a disease caused by parasites transmitted by certain species of sand flies, the US Army News Service said this week.

The assay was developed by the Army Medical Research and Materiel Command in collaboration with the Walter Reed Army Institute of Research and Cepheid under a collaboration begun in 2005.

The assay will help diagnose cutaneous leishmaniasis in the field, where thousands of US troops serving in Iraq and Afghanistan have contracted the disease in recent years. Though not considered life threatening, the disease can cause disfiguring skin ulcers that take months to heal and cause scarring, the US Army said.

Until now, there were no FDA cleared devices for diagnosing the disease. Traditional testing methods require a small tissue sample of the skin ulcer lesion, which are then examined under a microscope and cultured 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 Army said, the Smart Leish PCR test can consistently provide results within hours of sample collection.

Smart Leish PCR runs on Cepheid's SmartCycler instrument and uses the company's proprietary bead technology, the US Army said.

In a statement, Lisa Hochberg of WRAIR's division of entomology said that the assay represents the first FDA-cleared real-time PCR diagnostic device for infectious diseases developed by the Army.

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