News Release

For Immediate Release -- Nov. 14, 2014

Leishmania Rapid Diagnostic Device Receives FDA Clearance

Fort Detrick, Md. - The U.S. Army Medical Materiel Development Activity announced today the CL Detect™ Rapid Test, manufactured by InBios International, Inc. received FDA clearance. The CL Detect™ is a hand-held "dipstick" device for the rapid diagnosis of cutaneous leishmaniasis.

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.

"Results from the CL Detect™ are available within 30 minutes -- a significant improvement over the current process," said Lt. Col. Jeanne Norwood, product manager for the CL Detect™ at USAMMDA. "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."

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.

"This diagnostic device builds on the work being done at USAMRMC to rapidly diagnose and treat people exposed to cutaneous leishmaniasis, a parasitic disease transmitted through the bite of an infected sand fly that causes disfiguring lesions," said Dr. Kenneth Bertram, Principal Assistant for Acquisition at the U.S. Army Medical Research and Materiel Command.

The CL Detect™ was developed by the Army in partnership with InBios International, the Institut Pasteur de Tunis in Tunisia, Walter Reed Army Institute of Research, and the U.S. Army Small Business Innovation Research Program. The U.S. Army SBIR Program allowed InBios, a small, U.S. medical device manufacturer, 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.

"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.

###