Agnostic Metagenomic Next-Generation Sequencing (mNGS) for Clinical Diagnostics

The Capability Program Executive for Chemical, Biological, Radiological, and Nuclear Defense (CPE CBRND) is issuing a Sources‑Sought RFI (Solicitation W911SR‑26‑R‑MNGS) to identify mature (TR L 4 or higher) portable, battery‑operated metagenomic next‑generation sequencing (mNGS) systems that can rapidly, hypothesis‑free identify viral, bacterial, fungal, or parasitic pathogens—including traditional, novel, engineered, or emerging agents—from human clinical samples in far‑forward or forward‑laboratory settings. Respondents must submit a ≤5‑page white paper and a one‑page Quad Chart covering the project objective, product benefit, high‑level development schedule, ROM cost, and any IP or data‑rights assertions. The government will prioritize the “Technical Approach & Product Maturity” and “Bioinformatics & Clinical Interpretation” sections, requiring automated quality filtering, host‑subtraction, taxonomic classification with validated reporting thresholds and confidence metrics; a stretch goal is the ability to analyze host transcriptomic data to identify infection‑specific biomarkers. The system must be ready to pursue FDA regulatory pathways (EUA, 510(k), de novo) and meet CLIA waiver criteria, with a clear plan for manufacturing scalability, shelf‑life, and supply‑chain support. In parallel, CPE CBRND seeks independent Test & Evaluation (T&E) organizations to validate such mNGS diagnostics. Interested T&E firms should provide a separate ≤2‑page white paper describing corporate experience with regulated medical device and NGS platform validation, laboratory capabilities (including biosafety levels and handling of complex clinical matrices), regulatory‑validation experience for FDA submissions, and past performance for government or industry diagnostic programs. Additional information on manufacturing capacity, scalability, and company vision, as well as proposed teaming strategies with T&E partners, is also requested. Responses are to be sent to mcdc@ati.org with the appropriate subject line; this RFI is for information and planning only and does not constitute a solicitation or contract commitment.

Notice ID

eb72e75fd1084ee6a526b9f36277e943

Solicitation Number

W911SR-26-R-MNGS

NAICS Code

N/A

Classification Code

N/A