USA flag logo/image

An Official Website of the United States Government

Neutrophil CD64 Assay for Human Sepsis and Infection

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
60447
Program Year/Program:
2004 / SBIR
Agency Tracking Number:
AI051005
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
TRILLIUM DIAGNOSTICS, LLC
TRILLIUM DIAGNOSTICS, LLC 11 RICKER PK, A1 PORTLAND, ME 04101
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2004
Title: Neutrophil CD64 Assay for Human Sepsis and Infection
Agency: HHS
Contract: 2R44AI051005-02
Award Amount: $851,831.00
 

Abstract:

DESCRIPTION (provided by applicant): 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.

Principal Investigator:

Bruce H. Davis
2078858113
DAVISB@MMC.ORG

Business Contact:

Bruce Davis
2077738964
DAVISB@MMC.ORG
Small Business Information at Submission:

TRILLIUM DIAGNOSTICS, LLC
TRILLIUM DIAGNOSTICS, LLC 11 RICKER PK, A1 PORTLAND, ME 04101

EIN/Tax ID: 383309563
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No