SBIR Phase II: Automated Gram Stain Interpretation Via Digital Holographic Microscopy

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve access to high-quality diagnostic testing by automating the labor intensive Gram stain test. By providing rapid, consistent, and accurate Gram stain interpretation, this project has the potential to reduce diagnostic errors and shorten time to appropriate therapy. This Small Business Innovation Research (SBIR) Phase II project will develop and validate a compact, cost-effective imaging platform that integrates computational imaging with advanced artificial intelligence to automate Gram stain microscopy. Building upon Phase I proof-of-concept results, this project will finalize a hybrid imaging system capable of high-throughput, full-slide scanning across a wide range of clinical specimens. Research objectives include expanding the system’s ability to analyze various sample types, enhancing interpretation algorithms to recognize additional pathogens and host cell features, and scaling throughput with a 36-slide batch processing module. Validation studies will benchmark the system against expert microbiologists using deidentified slides, with a goal of achieving high concordance across multiple laboratories. Successful completion of this project will prepare the system for commercial launch as a laboratory-developed test, providing a robust, scalable solution that enhances diagnostic accuracy and reduces variability. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.