SBIR-STTR Award

This proposal describes feasibility testing of a quantitative molecular assay using monoclonal antibody, fluorescence, and flow cytometry technology for a white blood cell molecule, called 0064. The expression of CD64 increases rapidly on the blood leukocyte neutrophil subpopulation due to molecular activation by inflammatory mediators or cytokines. Quantitative measurement of neutrophil cD64 expression can identify patients with the systemic acute inflammatory response occurring in sepsis, infection or tissue injury. The CD64 assay is anticipated to have medical utility in the triage of patients with infection to appropriate medical therapy, assist in therapeutic monitoring of patients on antibiotic therapy, reduce the unnecessary use of antibiotics, thus minimizing the incidence of antibiotic resistant organisms. The objectives are to optimize use of patented monoclonal antibodies in a 0064 assay, define formulation for assay commercialization, validate manufacturing procedures, improve precision and sensitivity of the assay, confirm utility of a novel quantitative approach to neutrophil cd64 expression using flow cytometry, develop proprietary computer software to improve assay precision, demonstrate feasibility for an stabilized assay control product, and prepare the assay design for subsequent Phase II clinical trials to demonstrate superiority compared to current clinical laboratory tests for sepsis, infection and acute inflammatory diseases.

Thesaurus Terms:
CD antigen, bacterial disease, bioassay, blood toxicology, flow cytometry, monoclonal antibody, neutrophil, technology /technique development colony stimulating factor, computer program /software, interferon gamma clinical research, fluorescence, human tissue

This proposal describes assessment of the clinical utility of a quantitative molecular assay using patented monoclonal antibodies, fluorescence, analytical software, and flow cytometry technology for a white blood cell molecule, called CD64. The expression of CD64 increases rapidly on the blood leukocyte neutrophil subpopulation due to molecular activation of these cells by inflammatory mediators or cytokines. Quantitative measurement of neutrophil CD64 expression with this assay, named Leuko64, can identify the systemic acute inflammatory response occurring in patients with sepsis, infection or tissue injury. The Leuko64 assay is anticipated to have medical utility in the triage of patients with suspected infection to appropriate medical therapy, assist in therapeutic monitoring of patients on antibiotic therapy and thereby reduce the unnecessary use of antibiotics, thus minimizing the pressure for the development of antibiotic resistant organisms. The Leuko64 assay represents one of the first diagnostic assay systems to utilize cellular molecular changes to detect and monitor the immune response to infection and sepsis. The objectives of this proposal are to 1) validate the clinical performance of Leuko64, 2) demonstrate its superiority as a diagnostic assay for detection of infection and sepsis compared to the clinical laboratory tests currently used in contemporary medical practice, 3) confirm the reliability of the automated proprietary computer software developed during the phase I work, 4) develop a stabilized assay control product for the assay, and 5) to develop a prototype second generation assay integrated into a hematology blood cell counter.

Thesaurus Terms:
CD antigen, bacterial disease, bioassay, blood toxicology, flow cytometry, monoclonal antibody, neutrophil, septicemia, technology /technique development colony stimulating factor, computer program /software, interferon gamma clinical research, fluorescence, human tissue