Description
The ASSURE program aims to develop innovative, multiplexed, high-throughput, scalable, and sample-sparing assays that provide comprehensive evaluation of an individual's immune status as a response to either infection or vaccination. The program seeks to de-risk the development of novel assay platform technologies with the ultimate goal of establishing new, qualified assays primarily for BARDA and vaccine developers to comprehensively assess the immune response and status elicited by vaccines and/or infection due to CBRN threats, pandemic influenza, or other emerging infectious diseases. Key aspects of the program include:
* Assay innovation: developing assays that capture comprehensive information on the quality, breadth, and durability of protection conferred by vaccination and/or infection
* Sample collection and processing innovation: developing sample collection and processing technologies compatible with novel assays
* Technical requirements: abstracts should include a description of immune markers, discussion of the number of biomarkers, description of compatibility with high-throughput analysis, and proposal of reasonable performance metrics
* Evaluation factors: technical approach, relevant experience, cost reasonableness, and best value