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MBio Diagnostics Awarded Contract for Diagnostic Development With the U.S. Army

MBio Diagnostics, Inc. announced today it was awarded a three-year development contract with the U.S. Army's Walter Reed Army Institute of Research (WRAIR) for the "Development of a Ruggedized Portable Cartridge Reader for Malaria Diagnosis."

Under this contract, MBio Diagnostics will develop a low cost, multi-analyte "point-of-care" (POC) diagnostic device for malaria with enhanced sensitivity, quantitation capabilities, and automated data capture and transmission, using the company's planar waveguide LightDeck® technology. The work will be carried out collaboratively with Dr. John Waitumbi of the United States Army Medical Research Unit-Kenya (USAMRU-K), which is a "Special Foreign Activity" of the WRAIR headquartered in Nairobi, Kenya. The USAMRU-K unit develops and tests improved means for predicting, detecting, preventing, and treating infectious disease threats important to the U.S. Military as well as conducts surveillance, training, research and response activities related to emerging infectious diseases threats.

Commenting on the contract, Chris Myatt, CEO of MBio Diagnostics, said, "We are thrilled to be working with Dr. Waitumbi and his team at Walter Reed's USAMRU-K unit to develop a key diagnostic for use in regions where malaria is endemic. This fits naturally with our infectious disease program, where we focus on diagnostics for HIV, influenza, and hemorrhagic fevers."

"We are looking for a high-quality diagnostic device that would strengthen monitoring and early care of deployed US Service Members and civilians in areas where malaria is endemic," said Colonel Rodney Coldren, Director of the Department of Emerging Infectious Diseases at USAMRU-K. "This contract begins the process of analysis and development."

It is estimated by the World Health Organization that malaria causes more than 600,000 deaths annually, with 90 percent of those occurring in Africa. Development of medical products for infectious diseases requires access to study populations in field sites where the disease agents are endemic as well as access to clinical trials centers capable of conducting high quality and regulated vaccine and therapeutic trials. Specifically, malaria, HIV/AIDS, enteric pathogens, influenza, hemorrhagic fever viruses, and arthropod-borne diseases are among the most important of the militarily-relevant infectious agents.

To date, malaria rapid diagnostic tests (RDTs) have significant limitations. MBio's planar waveguide technology has a needed and unique ability to combine sensitivity, quantitative analysis, batch processing, automated data capture and transmission, as well as ability to configure for a panel of febrile illnesses.

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