Threat Agnostic Diagnostics

The following awards were made in support of the Threat Agnostic Diagnostics initiative (RPP-26-09-AgDx), which will support the advanced development, clinical evaluation, and FDA clearance of metagenomic Next-Generation Sequencing (mNGS)-based diagnostic assays focused on viral and bacterial pathogens. The product sought is a highly flexible, rapidly adaptable system that identifies known viral and bacterial pathogens (e.g., detection/identification of all known viral and bacterial pathogens in a respiratory specimen) and can quickly be adapted with changes to only databases or software to detect new viral and bacterial pathogens during an event or public health emergency. Both laboratory and point-of-care tests are sought for use on existing mNGS-based sequencing platforms or on platforms already in development.

SEQ-OUT

Project Objective: The objective of this project is to advance the SEQ-OUT™ pathogen-agnostic mNGS diagnostic platform from its current prototype stage through system development, integration, manufacturing transition, and analytical validation to support future regulatory submission for the detection and characterization of viral and bacterial pathogens.

Project Details

Member Organization: Signature Science LLC
Award Date: 09/29/2026
Award Amount: $10,196,058
Project Duration: 24 Months

Solicitation Number: RPP-26-09-AgDx