GEN Exclusives

More »

GEN News Highlights

More »
Jul 22, 2013

NIAID Grants MBio $1.4M to Develop POC HIV Diagnostic

  • 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.

Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content


GEN Jobs powered by connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
More »

Be sure to take the GEN Poll

Patient Access to Genetic Information

Do you think patients have the absolute right to gain access to their own genetic information from medical or clinical laboratories?

More »