The National Institute of Allergy and Infectious Diseases (NIAID) has awarded Boulder, CO-based firm MBio Diagnostics $1.4 million to develop a low-cost, point-of-care (POC) HIV antigen/antibody combination diagnostic device. The two-year SBIR award will help the firm continue work from a Phase I NIH project in which research and development of such a diagnostic platform reportedly met or exceeded technical milestones.
According to MBio, its HIV antigen and antibody assays provided a combined performance that exceeded performance of FDA-approved rapid tests, and provided near equivalence of other laboratory-based tests. The firm has already been collaborating with a team of infectious disease specialists at the University of California, San Diego (UCSD), and said it plans to tap the group’s clinical expertise in acute HIV infection diagnosis as part of this program.
“There are currently no FDA-approved POC tests that directly target HIV viral antigens,” Michael J. Lochhead, Ph.D., MBio Diagnostics’ CTO, said in a statement. “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 CLIA waiver guidance requirements.”
“The ability to validate a system using well-characterized early HIV infection specimens . . . will accelerate our pipeline of diagnostic products for tuberculosis, hepatitis C, as well as other indications,” added Christopher J. Myatt, Ph.D., MBio Diagnostics’ founder and CEO.