USAMMDA Celebrates FDA Clearance of Leishmania Rapid Diagnostic Device

Leishmania Rapid Diagnostic Device team

The Leishmania Rapid Diagnostic Device team was recognized for their role in the U.S. Food and Drug Administration clearance of the product. Left to Right: Col. (Ret.) Max Grogl, Dr. Janet Ransom, Gerry LoSardo, Louis Jasper, Stephanie Harvey, Dr. William McCarthy, Maj. Mara Kreishman-Deitrick, Lt. Col. Jeanne Norwood, Col. Pete Weina, Monica O'Guinn, Andi Zak, Dr. Chandar Thakur, Dr. Bob Rice, Micaela Bowers, Deana Eichelberger and Ron Antonio. (Courtesy photo)

In a small but significant ceremony Feb. 4, the U.S. Army Medical Materiel Development Activity recognized contributors to the successful U.S. Food and Drug Administration clearance of the Leishmania Rapid Diagnostic Device.

"Today was an exciting day for the USAMMDA," said Col. Stephen Dalal, commander of the USAMMDA. "We recognized the outstanding efforts of an integrated product team of dedicated professionals from various technical backgrounds such as budgeting, contracting, legal, regulatory, medical and product management to successfully develop and field the LRDD to the warfighter, and the nation."

The LRDD, manufactured by InBios International, Inc. and marketed as CL Detect™, received FDA clearance Nov. 12, 2014. The LRDD is a hand-held "dipstick" device for the rapid diagnosis of cutaneous leishmaniasis, a parasitic disease that causes disfiguring lesions.

According to Lt. Col. Jeanne Norwood, product manager for the CL Detect™ at the USAMMDA, results from the CL Detect™ are available within 30 minutes, which means treatment for a positive CL diagnosis can begin immediately, reducing lost duty time and improving healthcare and morale for U.S. military personnel in numerous areas of operations.

The team recognized in this ceremony is responsible for taking this product through the necessary stages in order to get a safe and effective product in the hands of our Service Members.

"Today was about recognizing the members of the team that spent countless hours ensuring the success of the program," said Norwood.

Col. Peter Weina, co-IPT chair from the Walter Reed National Military Medical Center, and Maj. Mara Kreishman-Detrick, assistant product manager for the CL Detect™ at the Walter Reed Army Institute of Research, were awarded the Army Achievement Medals.

The Achievement Medal for Civilian Service was awarded to Dr. Hank Gardiner, Directorate of Combat and Doctrine Development; Kelly Green, U.S. Army Medical Research Acquisition Agency; Melissa Askin, chief of Clinical Operations at the USAMMDA; Micaela Bowers, contracting officer at the U.S. Army Medical Research Acquisition Activity; Jeremiah Kelly, legal advisor for the Office of the Staff Judge Advocate; Dr. William McCarthy, chief of Biostatistics at the USAMMDA; Ron Antonio, contracting specialist at the USAMRAA; and Louis Jasper, former product manager at the USAMMDA.

Certificates of Appreciation were presented to Gerry LoSardo, Monica O'Guinn, Stephanie Harvey, Robert Rice, Deana Eichelberger, Dr. Chandar Thakur, Andi Zak, Denise McKinney, Col. (ret.) Max Grogl, Dr. Janet Ransom, Anne Novitt-Moreno and Bethany Matheson.

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Last Modified Date: 06-Feb-2015