Agnostic Metagenomic Next-Generation Sequencing (mNGS) for Clinical Diagnostics
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Department of the Army is conducting market research through a Sources Sought / Request for Information (RFI) for Agnostic Metagenomic Next-Generation Sequencing (mNGS) for Clinical Diagnostics. This initiative seeks to develop a field-forward, threat-agnostic mNGS capability for rapid identification of infectious disease agents. Responses are due May 22, 2026.
Purpose & Scope
The Capability Program Executive for Chemical, Biological, Radiological, and Nuclear Defense (CPE CBRND) aims to address a critical gap in military medical diagnostics by enabling hypothesis-free pathogen identification, particularly in resource-limited or austere settings. This RFI invites industry partners to collaborate on advancing mature, portable, and integrated mNGS systems. The goal is to overcome technical and regulatory hurdles preventing mNGS deployment as a routine clinical diagnostic tool. Unlike targeted assays, mNGS offers comprehensive, unbiased detection of viral, bacterial, fungal, and parasitic pathogens from human clinical samples.
Key Requirements & Desired Characteristics
The program seeks cutting-edge, end-to-end solutions addressing critical challenges, with a preference for systems at Technology Readiness Level (TRL) 4 or higher. Key areas of interest include:
- Integrated "Sample-to-Answer" System: Fully-automated, ruggedized, backpack-sized, battery-operable platforms with minimal manual steps, suitable for Role 1-4 environments.
- Host Nucleic Acid Depletion: Efficient methods for removing human host DNA/RNA, or acceptable pathogen enrichment strategies.
- Field-Forward Bioinformatics: Computationally efficient, offline analysis with curated, regulatory-grade databases that can be securely updated.
- Clinical Decision Support: Advanced interpretive tools providing actionable reports for non-specialist operators, meeting FDA requirements for clinical relevance.
- Regulatory Path: A viable and proactive strategy for achieving FDA authorization (likely De Novo approval for a regulated clinical diagnostic, EUA, or 510(k)) and a scalable cGMP-compliant manufacturing plan (21 CFR 820, ISO 13485).
- Stretch Goal: Host-Response Profiling (mRNA sequencing) to identify gene expression signatures indicative of infection.
Submission Details
Respondents are requested to submit a white paper (not exceeding five pages) and a one-page Quad Chart. The Quad Chart should include project objective, product benefit, development schedule, Rough Order of Magnitude (ROM) cost, and Intellectual Property rights. The government will place the greatest emphasis on "Technical Approach & Product Maturity" and "Bioinformatics & Clinical Interpretation." Independent Test & Evaluation (T&E) organizations are also invited to submit a separate two-page white paper detailing their capabilities.
Additional Notes
This is an information request only and does not constitute a Request for Proposal (RFP) or a promise to issue one. Unsolicited proposals will not be considered. Responses are for planning purposes only and will not form a binding contract. Responses are due by May 22, 2026, 7:00 PM ET. Contact: Keith Pereira, keith.d.pereira.civ@army.mil.