MBio funded to work on HIV diagnostic test

BOULDER – MBio Diagnostics Inc. in Boulder has received $1.4 million to develop a device that would quickly diagnose HIV antigen and antibodies.

The award from the Small Business Innovative Research program will continue work for two years based on the results of a Phase I project in which research and development of a point-of-care antigen/antibody combination diagnostic device met or exceeded technical milestones.

MBio’s HIV antigen and antibody assays combined outperform FDA approved rapid tests, and provide near equivalence of much more complicated laboratory-based tests.

MBio has had a longstanding collaboration with a team of infectious-disease experts at the University of California, San Diego and will be building on the UCSD group’s clinical expertise in acute HIV infection diagnosis as part of this development program.

Michael J. Lochhead, MBio’s chief technology officer, said there “is an increasing awareness that acutely infected individuals disproportionately contribute to the spread of the disease. These individuals remain the most difficult to identify, as infectivity is highest prior to the appearance of the HIV antibodies that serve as the basis of serological diagnostics.

There are currently no FDA-approved point-of-care tests that directly target HIV viral antigens. A major goal of the project is to simplify assay workflow to the point it can be run by minimally trained operators in a variety of healthcare settings.

Christopher J. Myatt, MBio’s founder and chief executive, said the ability to validate a system using well characterized early HIV infection specimens, and to place such systems in a setting capturing feedback with capillary and venous blood samples, will accelerate our pipeline of diagnostic products for tuberculosis, hepatitis C, as well as other indications.”

The National Institute of Allergy and Infectious is a division of Diseases National Institutes of Health.

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