The Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR), has released a new opportunity under the Rapid Response Partnership Vehicle (RRPV): the Assay Development for Superior Understanding of Response and Efficacy (ASSURE) program. Designed to strengthen national health security, ASSURE seeks to accelerate the development of innovative, multiplexed immune assays that can better characterize immune responses to vaccines, infections, and emerging biological threats.
ASSURE Solicitation Details
ASSURE addresses a long-recognized gap in medical countermeasure development: current immunogenicity assessments rely heavily on antibody measurements, which may not reflect the full scope of protective immunity. BARDA highlights the need for next-generation assays that encompass cell-mediated, mucosal, and innate immune responses, while remaining scalable, high throughput, and sample sparing.
To meet these goals, the solicitation is structured into multiple submission areas:
- Assay Innovation (Area 1): Development and clinical evaluation of novel assays capable of capturing the breadth, quality, and durability of immune protection across diverse pathogens.
- Sample Collection and Processing Innovation Paired with Novel Assays (Area 2): Technologies that simplify the collection, transport, and processing of samples that will be used in the newly developed assays.
Sample Collection and Processing Innovation for Existing Commercial Assays (Area 3): Improvements that enhance efficiency, scalability, and multiplexing potential in assays already on the market.
Submission Process
Stage 1: Submission of a 5-page abstract and quad chart.
Stage 2 (Invitation only): Submission of a full technical and cost proposal. Selected offerors will then be invited to present their proposed project to BARDA via a virtual presentation.
ASSURE Requirements and Expectations
The solicitation places strong emphasis on clinical utility, scalability, and commercialization potential. BARDA expects offerors to demonstrate how their assays or sample processing technologies will:
- Measure relevant immune markers, such as functional T cell responses or mucosal immunity.
- Scale to analyze large patient cohorts (> 1,000 samples/run, >10,000 trial participants).
- Operate with minimal sample volumes and support multiple sample types.
- Be validated using clinically relevant samples and meet turnaround times aligned with clinical workflows.
Projects must also include practical commercialization and regulatory plans, cost-effective assay designs, and considerations for pediatric or immunocompromised populations. Notably, biomarker discovery alone is out of scope; the focus is on product-oriented assay development with clearly defined intended uses.
Key Dates for Proposers
BARDA provides several important deadlines under RRPV 26-07-ASSURE:
- November 26, 2025 at 12 PM ET: Questions Due to RRPV CMF
- December 3, 2025 (approx.): Public Release of Q&A
- December 18, 2025 at 1 PM ET: Abstracts Due via RRPV BDR Portal
These steps define the Stage 1 submission process. Offerors selected to proceed will receive Stage 2 instructions, due dates, and presentation schedules directly from the RRPV Consortium Management Firm.
Funding, Award Structure, and Period of Performance
BARDA anticipates approximately 8 million dollars in total U.S. Government funding spread across 4-5 awards for the ASSURE program, although this may change based on proposal quality and program priorities. Individual scopes and budgets may vary.
Projects are expected to run up to 24 months, although performers may propose durations aligned with their technical approach and planned milestones. BARDA notes that the expected project start date will fall in the third quarter of calendar year 2026, subject to negotiations. Cost sharing is encouraged but not required.
Advancing Public Health Through Better Immune Measurement
The ASSURE program represents a key investment in the future of vaccine and infectious disease preparedness. By enabling assays that capture comprehensive immune responses, including those most relevant to protection, BARDA is helping public health agencies, vaccine developers, and clinical researchers better evaluate product performance and understand immunity over time. These innovations have the potential to accelerate vaccine development, inform correlates of protection, and improve preparedness for CBRN threats, pandemic influenza, and emerging infectious diseases.
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