Microarray Assay for Detection of Lab Animal Pathogens
Department of Health and Human Services
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Small Business Information
AMBERGEN, INC., 100 Beaver Street, Waltham, MA, 02453
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): Research animals play a crucial role in biomedical research, drug development and toxicology testing. It is estimated that an average population of over 30 million mice and rats is maintained in the U.S. alone for these purposes. The presence of undetected infections can compromise experiments and/or cause the loss of valuable strains or entire colonies. The goal of this project is to develop a cost-effective microarray-based sero-surveillance system for a comprehensive health assessment of laboratory animals with a special focus on mice. The Murine MonitorTM System will be capable of simultaneously testing for the presence of up to 9 relevant murine pathogens, requiring only 10-20 microliters of serum. During Phase I, several critical components of the Murine MonitorTM have been extensively evaluated including a novel proprietary array substrate and two prototype platforms, demonstrating the feasibility of this approach. During Phase II, our specific aims will focus on: a) expression and validation of recombinant antigens, b) development of a 4-pathogen Surveillance Assay, c) development of a 9-pathogen Surveillance Plus Assay. For both assay panels, the critical assay parameters of sensitivity, specificity and precision will be determined and optimized to meet performance criteria. After internal validation, prototype Murine MonitorTM systems will be placed at two collaborating sites for testing. An ultra-low-cost novel reader aimed at small laboratories consisting of a hand-held reader and associated microfluidic cartridge which is preloaded with reagents will be manufactured for this project by Claros Diagnostics, Inc. Dr. Susan Compton, Chief of the Molecular, Serological and Virological Diagnostics Unit at Yale University School of Medicine and Animal Facility will serve as a consultant and will participate in beta-testing. Dr James Fahey, Chief of Diagnostic Services at The Jackson Laboratory, which houses over 1 million mice, will also participate in beta-testing the Murine Monitor and provide feedback on its performance.
* information listed above is at the time of submission.