Phlebotomus spp. sand flies are a vector for leishmaniasis. Credit: CDC/WHO
A hand-held “dipstick” device for the rapid diagnosis of cutaneous leishmaniasis, co-developed by the U.S. Army and InBios International, has received clearance from the Food and Drug Administration (FDA).
Development of the device was backed by the U.S. Army Small Business Innovation Research (SBIR) Program, which allowed InBios the opportunity to provide an innovative research and development solution in response to a critical Army need: rapid diagnosis of cutaneous leishmaniasis in an operational setting.
The CL Detect™ Rapid Test provides results within 30 minutes, a significant improvement over the current process.
“Diagnosing CL often requires samples to be shipped to and tested at stateside laboratories. This is important because rapid diagnosis means treatment can begin immediately,” said Lt. Col. Jeanne Norwood, product manager for the CL Detect at the U.S. Army Medical Materiel Development Activity (USAMMDA).
Cutaneous leishmaniasis is a parasitic disease that causes disfiguring lesions. It is mainly found in the tropical and subtropical areas in the Middle East, southwest Asia, the Mediterranean coast, sub-Saharan Africa, Mexico, and Central and South America, and it is spread through the bite of infected sand flies. It places 350 million people at risk worldwide, with 1.5 million new cases emerging annually, including U.S. service members serving abroad.
For the DoD, the CL Detect will serve as an important asset in the general diagnosis of skin lesions, distinguishing cutaneous leishmaniasis from other important infectious diseases with similar symptoms. It will allow implementation of appropriate treatments which can reduce the severity of scarring, reduce lost duty time and improve healthcare and morale for U.S. military personnel in numerous areas of operations.
“Dedicated product managers drive transformational results by partnering with small businesses. 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,” said JR Myers, project manager for USAMRMC SBIR.
InBios International, Inc. is a medical device manufacturer located in Seattle, Washington.