Assay Development for Superior Understanding of Response and Efficacy (ASSURE)

The ASSURE program under solicitation number RRPV-26-07-ASSURE issued by BARDA aims to advance the development of innovative, multiplexed, and scalable immune assays capable of high-throughput analysis and minimal sample use. These assays are intended to provide a comprehensive assessment of individual immune responses to infection or vaccination, especially targeting critical threats such as chemical, biological, radiological, and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases. The program’s objective is to de-risk new assay platform technologies and establish qualified assays primarily supporting BARDA and vaccine developers for evaluating immune status, potentially enabling novel correlates of protection. This solicitation is a Request for Project Proposals (RPP) managed under the Rapid Response Partnership Vehicle (RRPV) Base Agreement framework, with proposals due by December 18, 2025. The place of performance is centered in South Carolina, with the contracting office based in Washington, DC. Offerors must submit a five-page abstract and a one-page quad chart via the BARDA Digital Resource portal, adhering strictly to formatting and submission guidelines. Evaluation factors prioritize the technical approach, relevant organizational and team experience, and cost reasonableness, with award decisions based on a best value trade-off rather than lowest price alone. Key contract requirements include detailed descriptions of key personnel, teaming arrangements, and regulatory and commercialization strategies. All deliverables will generally be subject to unlimited government data rights under the RRPV Base Agreement, with explicit declarations required for any assertions of restricted data rights. The program emphasizes assay sensitivity, specificity, throughput (>10,000 samples), reproducibility, processing of minimally invasive sample types (e.g., dried blood spots, saliva), and regulatory alignment with clinical validation and commercialization pathways. Inspection and acceptance activities are conducted primarily by BARDA, with deliverables reviewed and accepted at the government’s headquarters following submission through the digital portal. The contract does not specify packaging, preservation, marking, or bar-coding standards and contains no references to military standards or FOB terms, reflecting its research and development focus rather than logistics. Proposed efforts are expected to run for up to 24 months, beginning in Q3 2026, with no fixed contract value disclosed in the solicitation stage. The contract includes provisions for future awards under a Basket Provision enabling technically acceptable but unfunded proposals to receive funding within two years without recompetition. Communication and questions are directed through a designated point of contact at Advanced Technology International, which manages the RRPV consortium on behalf of BARDA. Overall, this solicitation seeks to