Overview of Solicitation
The Medical CBRN Defense Consortium (MCDC), managed by Advanced Technology International (ATI) in support of the Capability Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (CPE CBRND), has released a Request for Information (RFI) titled Agnostic Metagenomic Next-Generation Sequencing (mNGS) for Clinical Diagnostics.
Unlike traditional targeted assays, which require predefined pathogen panels, mNGS systems enable unbiased detection of viral, bacterial, fungal, and parasitic organisms directly from clinical samples. This capability is particularly valuable for identifying infections of unknown origin, detecting emerging or engineered threats, and supporting operational decision-making in contested or resource-limited environments.
This RFI represents a strategic effort to assess the current landscape of metagenomic sequencing technologies capable of enabling rapid, field-forward infectious disease diagnostics. The initiative is focused on advancing portable, integrated mNGS systems that can identify a broad range of pathogens without prior assumptions, addressing a critical gap in current diagnostic capabilities. Importantly, this RFI is issued strictly for information and planning purposes and does not constitute a solicitation or guarantee of future funding.
Technical Focus Areas
CPE CBRND is seeking input from industry on mature (Technology Readiness Level 4 or higher), end-to-end mNGS diagnostic systems that can overcome both technical and regulatory barriers to routine clinical deployment. Key technical focus areas include:
- Integrated Sample-to-Answer Systems
Fully automated, ruggedized platforms that incorporate nucleic acid extraction, library preparation, sequencing, and bioinformatics into a single workflow with minimal user intervention. - Host Nucleic Acid Depletion
Efficient and unbiased removal of human DNA or RNA to improve microbial detection sensitivity, particularly in complex samples such as blood. - Field-Forward Bioinformatics
Offline-capable analysis pipelines with curated and secure databases, enabling reliable pathogen identification without reliance on cloud connectivity. - Clinical Decision Support
Tools that distinguish true pathogens from contaminants and provide actionable outputs for non-specialist operators. - Host-Response Profiling (“Stretch Goal”)
Advanced capabilities to analyze host gene expression patterns to infer infection type or severity when direct pathogen detection is limited.
Beyond technical performance, the RFI places strong emphasis on regulatory readiness and scalability. Respondents are expected to outline viable pathways to U.S. Food and Drug Administration authorization, such as Emergency Use Authorization, 510(k), or de novo classification, along with manufacturing strategies capable of supporting military demand.
Submission
MCDC membership is not required for the submission to this RFI. Submissions must include a white paper of no more than five pages and a one-page quad chart. The government will prioritize responses that demonstrate integrated, automated solutions supported by robust performance data and clear clinical relevance.
All other RFI responses are due May 20, 2026 (12PM ET).
Key Dates
MCDC will host in-person one-on-one engagement sessions during its Annual Membership Meeting on May 12 to 13, 2026 in National Harbor. Organizations must meet the following deadlines to be eligible:
- In-person Engagement Request Deadline: May 1, 2026 (12PM ET)
- RFI Submissions for In-Person Participation: May 7, 2026
- In-Person Engagement Sessions: May 12-13, 2026 (Annual Membership Meeting)
Additional virtual engagement sessions will be offered following the closing of the RFI for respondents who are unable to attend in person.
Additional Information
This effort is positioned as a foundational step toward enabling next-generation diagnostic capabilities that support military medical readiness and operational resilience. By enabling early and accurate pathogen identification, mNGS systems have the potential to improve treatment decisions, enhance outbreak response, and mitigate the impact of both natural and engineered biological threats.
The RFI also highlights interest in collaboration with Test and Evaluation partners capable of supporting validation and regulatory approval processes. While MCDC membership is not required to respond to this RFI, it may become necessary for participation in any future solicitation that emerges from this effort.
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