Next-Generation RAPID-iNose Pioneering Intelligent Diagnostics: Enabling Precision Infection Management via Broad-Spectrum VOC Sensing and AI

NanoBioFab proposes the continued development and validation of the RAPID-iNose™ diagnostic platform, a novel, non-invasive system that uses a proprietary nanosensor array and embedded AI algorithms to rapidly detect and differentiate wound infections based on Volatile Organic Compounds (VOCs) emitted by pathogens. Supported by prior SBIR Phase I (W81XWH22P0132) and Phase II (HT942523C0045) funding, the RAPID-iNose™ system has demonstrated feasibility through in vitro, ex vivo, and in vivo validation, achieving high diagnostic accuracy for key wound pathogens including ESKAPEE species and select fungi. The platform integrates a high-surface-area 3D nanostructured sensor array, capable of detecting ppb-level VOCs, with a miniaturized, AI-driven hardware device that provides real-time infection alerts, even in austere environments.This Sequential Phase II project aims to advance the system from TRL 4/5 to TRL 6/7 by expanding its diagnostic capabilities, improving AI-driven classification algorithms, and constructing an optimized, field-ready prototype. Key objectives include: (1) developing a comprehensive VOC signature library for >100 clinically relevant bacterial and fungal species under diverse conditions; (2) identifying VOC biomarkers associated with antimicrobial resistance (AMR) and biofilm formation; and (3) refining the hardware and AI integration to enable species-level identification and resistance/biofilm detection. The project includes rigorous in vitro, ex vivo, and blinded validation studies to establish diagnostic performance across these expanded capabilities.The RAPID-iNose™ platform has been strategically designed for clinical and military use, offering rapid, point-of-care infection diagnostics where traditional culture-based methods are too slow or impractical. Through partnerships with Smith & Nephew, Nitto, JLABS, and the U.S. Army Institute of Surgical Research, NanoBioFab is well-positioned to transition RAPID-iNose™ into human clinical trials and future commercialization. This project represents a critical step toward realizing an intelligent, AI-powered diagnostic platform for precision infection management, capable of transforming both civilian wound care and combat casualty medicine.