The Biomedical Advanced Research and Development Authority (BARDA) has released a new Request for Project Proposals (RPP-26-09-AgDx) through the Rapid Response Partnership Vehicle (RRPV), seeking to revolutionize the nation’s diagnostic readiness for infectious disease threats. Managed by Advanced Technology International (ATI), the RRPV enables collaboration between industry, academia, and government to strengthen the United States’ biodefense capabilities. BARDA’s latest effort, focused on “Agnostic Diagnostics” (AgDx) aims to create adaptable, FDA-cleared technologies capable of detecting both known and emerging pathogens from a single clinical sample.
Solicitation Overview
Traditional diagnostics rely on targeted assays that identify specific pathogens. In contrast, agnostic diagnostics are pathogen-independent, capable of detecting any organism that can infect humans without prior identification. BARDA’s AgDx initiative seeks to transform Metagenomic Next-Generation Sequencing (mNGS) technologies into FDA-cleared diagnostic platforms ready for clinical use.
The RPP outlines BARDA’s vision for a flexible, comprehensive diagnostic ecosystem capable of quickly adapting to new or emerging threats through simple database or software updates. Such a capability would eliminate reliance on single-pathogen tests and enable clinicians to detect novel pathogens during the earliest stages of a public health emergency.
Research and Development Goals
The RRPV AgDx solicitation will fund the advanced development, clinical validation, and regulatory clearance of mNGS-based diagnostic assays that can identify all known viral and bacterial pathogens in a given specimen, such as a respiratory sample. Proposed solutions should provide end-to-end, sample-to-answer workflows, including sample collection, processing, sequencing, and data analysis using a validated database of known pathogens.
BARDA emphasizes integration with existing sequencing platforms to accelerate deployment within existing clinical infrastructure. Systems should demonstrate automated sample processing, minimal operator intervention, and the ability to deliver actionable clinical results in under 12 hours. Projects must also include a regulatory strategy for FDA 510(k) clearance or de novo approval, supported by analytical and clinical validation data.
The program will proceed in two competitive stages:
- Stage 1: Abstract (up to five pages) and one-page quad chart submission.
- Stage 2: (By invitation) Full technical and cost proposal.
Only RRPV consortium members are eligible to apply, and participation in Stage 1 does not guarantee an invitation to Stage 2.
Key Proposal Dates
- November 6, 2025: Proposers Conference (via Zoom)
- November 10, 2025, 12 PM ET: Deadline for submission of questions
- November 13, 2025 (approx.): Answers released publicly on the RRPV website
- November 20, 2025, 1 PM ET: Abstracts due via the BARDA Digital Resource (BDR) Portal
Funding and Award Information
BARDA anticipates making up to three awards under this RPP, with a total federal funding pool between $20 million and $40 million. The expected period of performance is up to three years, beginning in Q2 2026. Offerors are encouraged to propose cost sharing to strengthen government–industry collaboration, though it is not required.
Strengthening Public Health Preparedness
The AgDx program represents a major step forward in public health and biodefense preparedness, establishing a foundational diagnostic capability that can detect emerging pathogens within days of genomic sequence availability. By enabling flexible, FDA-cleared metagenomic diagnostics, BARDA aims to provide the nation with a resilient diagnostic infrastructure for rapid response during pandemics and biological emergencies.
If your company has considered applying for federal funding, your federal funding journey starts here. EverGlade Consulting is a national firm that helps organizations win and manage federal awards. We offer services ranging from Pursuit, Proposal and Post-Award support to comply with federal regulations at agencies including BARDA, ARPA-H, NIH, DTRA, JPEO, DOD, DIU, DOE, and DARPA.
