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Development of Sample Sparing Assays


Fast-Track proposals will be accepted. Number of anticipated awards: 1-3 Budget (direct costs):
Phase I: $300,000/year for up to 2 years
Phase II: $1,000,000/year for up to 3 years
The NIAID’s Division of Allergy, Immunology and Transplantation (DAIT) supports a wide range of research programs
spanning basic immunology, translational and clinical research on protective immunity and immune-mediated diseases, including autoimmune and primary immunodeficiency diseases, allergic diseases, graft-versus host disease (GVHD) and allograft rejection in organ, tissue and cell transplantation. Major constraints encountered in designing mechanism of action studies are related to limited quantity of biological specimens available for study and the paucity of robust, validated, miniaturized assays that can reliably and reproducibly assess immune function, disease state or effects of therapy. The restricted amounts of tissue, cells and fluids that can be collected from adult, pediatric or immunocompromised patients are often inadequate for the application of conventional assays that interrogate immune function. Novel, multi-parameter, sample sparing assays are needed to obtain maximal biologic information from limited amounts of biological materials.
Project Goal
The goal of this proposal is to accelerate commercial development of novel, standardized sample sparing assays that improve monitoring of the immune system using limited amounts of biological sample. Sample sparing immune assays of interest may include, but are not limited to monitoring or assessments of the following:
 Antigen-specific immune responses
 Distinct immune cell populations
 T-cell and B-cell regulatory networks
 Innate immune responses
 Markers of T-cell turnover and homing to lymphoid tissue
 Cytokine and signaling networks
 Gene and protein expression and regulation
 Mucosal inflammatory and innate immune response

Technologies that address novel sample preparation or cell isolation processes are also included in the areas of interest for this announcement.
The sample sparing assays developed through this funding opportunity must address challenges, gaps or unmet needs in the study of human immune responses and provide clear advantages over existing assays.
Phase I Activities
Depending on the developmental stage of the sample sparing assay the offeror may choose to perform one or more of the following:
 Preliminary studies performed in a suitable animal model or in human samples to evaluate the assay feasibility (scientific and technical)
 Establish assay’s quality of performance, assay reproducibility and validation
 Define process controls
 Establish potential for commercialization
Phase II Activities
 Further technology developments and assay improvements  Development and validation of prototype platforms  Development of quality control program to enable longitudinal measurements in compliance with Good Clinical
Laboratory Practice
This SBIR will not support:
 Any phase clinical trial  Identification of new biomarkers  Validation of biomarker candidates  Proposals focused exclusively on animal studies and animal disease models. Animals may be used in assay
development phase but all assays must be validated using primary human samples
 Development of assays using established cell lines without validation in primary human samples
 Virus-induced cancers
 Studies that do not fall within NIAID mission

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