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 (W6QK ACC-APG), on behalf of the Capability Program Executive for Chemical, Biological, Radiological, and Nuclear Defense (CPE CBRND), is conducting market research through this Sources Sought / Request for Information (RFI). The initiative seeks to identify mature, portable, and integrated Agnostic Metagenomic Next-Generation Sequencing (mNGS) systems for rapid clinical diagnostics of infectious disease agents in austere settings. This RFI also seeks Test & Evaluation (T&E) organizations capable of validating such systems.
Responses are due May 22, 2026.
Purpose & Scope
This RFI aims to address a critical gap in military medical diagnostics by enabling hypothesis-free identification of pathogens (viral, bacterial, fungal, parasitic) from human clinical samples. The goal is to develop a field-forward, threat-agnostic mNGS capability for rapid identification of traditional, novel, emerging, and engineered infectious disease agents. This supports Medical Readiness and Response capabilities and Formation Based Layered Protection.
Key areas of interest for system developers include:
- Integrated "Sample-to-Answer" System: Fully automated, ruggedized platforms.
- Host Nucleic Acid Depletion: Efficient methods for removing human DNA/RNA.
- Field-Forward Bioinformatics: Computationally efficient, offline analysis with curated, regulatory-grade databases.
- Clinical Decision Support: Advanced interpretive tools for non-specialist operators.
- Host-Response Profiling ("Stretch Goal"): Capability to analyze host transcriptomic response.
- Regulatory Path: Viable strategy for FDA authorization (EUA, 510(k), de novo) and scalable manufacturing.
Systems should ideally be backpack-sized, battery-operable, with minimal footprint, and at TRL 4 or higher. Optimal time-to-answer is less than 6 hours.
For T&E organizations, CPE CBRND seeks capabilities in validating mNGS clinical diagnostic systems, including experience with molecular diagnostics, NGS platforms, bioinformatics pipeline validation, laboratory capabilities (e.g., Biosafety Levels), and experience with FDA submission validation studies.
Contract & Timeline
- Type: Sources Sought / Request for Information (RFI)
- Set-Aside: None specified
- Response Due: May 22, 2026, 07:00 PM EDT
- Published: April 23, 2026, 05:52 PM EDT
Submission Requirements
- System Developers: White paper (not to exceed 5 pages) addressing technical approach, product maturity, bioinformatics, regulatory status, manufacturing, and company profile. A separate one-page Quad Chart is also required.
- T&E Partners: White paper (not to exceed 2 pages) detailing corporate experience, laboratory capabilities, regulatory/validation experience, and past performance.
- Submission Email: mcdc@ati.org (Subject line: Responding organization and RFI Title).
Evaluation
Responses will be used for information and planning purposes only. The government will place the greatest emphasis on "Technical Approach & Product Maturity" and "Bioinformatics & Clinical Interpretation" for system developers. This RFI does not constitute a solicitation or a promise to issue an RFP.
Points of Contact
- Government Technical: Jason Opdyke, jason.a.opdyke.civ@army.mil
- ATI Technical: Seth Tomblyn, seth.tomblyn@ati.org
- General/Administrative: Robert Harwell, mcdc@ati.org