POC Test Will Directly Target HIV

A low-cost, point-of-care (POC) HIV antigen/antibody combination diagnostic device is being developed.

The MBio Diagnostics (Boulder, CO, USA) HIV antigen and antibody assays provided a combined performance that significantly exceeded performance of US Food and Drug Administration (FDA; Silver Spring, MD, USA) approved rapid tests, and provides near equivalence of much more complicated laboratory-based tests. MBio Diagnostics, Inc. has a longstanding collaboration with a team of world-class infectious disease experts at the University of California, San Diego (UCSD; USA). The company will be building on the UCSD group’s extensive clinical expertise in acute HIV infection diagnosis as part of this development program.

The National Institute of Allergy and Infectious Diseases (Bethesda, MD, USA), a division of the National Institutes of Health (NIH), gave MBio Diagnostics a two-year USD 1.4 million award to develop the HIV antigen/antibody combination diagnostic device. The two-year award from the Small Business Innovative Research (SBIR) program will continue work from a Phase I NIH project in which research and development of a POC antigen/antibody combination diagnostic device met or exceeded technical milestones.

Michael J. Lochhead, MBio Diagnostics CTO and grant principal investigator, offered, “HIV infection remains a major public health crisis both in the United States and worldwide. 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 POC tests that directly target HIV viral antigens. A major goal of this project is to simplify assay workflow to the point it can be run by minimally trained operators in a variety of healthcare settings. The milestone aim of this project is a portable, integrated system delivered to clinical collaborators that meets FDA clinical laboratory improvement amendments (CLIA) waiver guidance requirements.”

Christopher J. Myatt, founder and CEO of MBio Diagnostics added, “The ability to validate a system using well characterized early HIV infection specimens, and to place such systems in an intended use setting capturing operational and usability feedback with capillary and venous blood samples, will accelerate our pipeline of diagnostic products for tuberculosis, hepatitis C, as well as other indications.”

The MBio system is initially being commercialized to manage treatment of HIV patients from a single drop of blood. The detection system is being developed for a broad menu of applications including multiplex assays and cellular analysis.

Related Links:
The MBio Diagnostics
US Food and Drug Administration
National Institute of Allergy and Infectious Diseases