Deep-UV Microscopy for Real-Time Adequacy Analysis of Bone Marrow Aspirates - PROJECT SUMMARY/ABSTRACT Cellia will improve the quality and reliability of bone marrow aspiration procedures by developing a point-of-care instrument for rapid, non-destructive sample adequacy assessment. Our approach is based on a recently developed label-free, deep-ultraviolet (UV) technique for cell imaging and analysis. Spicules, which indicate sample adequacy, are easily identifiable in unstained, pseudocolorized UV images due to the spicules’ strong light attenuation at 255 nm. The resulting deep-UV images can be generated in a fraction of a second and whole slide imaging can be done in a few minutes, making the technique suitable for real-time use during aspiration procedures. The deep-UV images are also nearly identical to the clinical standard Giemsa-stained slides, which take over 45 min to process. Label-free, deep-UV imaging can be combined with machine learning (ML) techniques for feature extraction and classification for automated quality assessment of aspirate smears in real time without a pathology technician. Phase I work, using data from N=51 patients, met or exceeded all milestones. This study demonstrated spicule adequacy assessment via visual assessment by a bedside pathology technician (current state of the art at tertiary hospitals) achieved 87.2% sensitivity (SE) and 67% specificity (SP), while automated assessment using deep-UV microscopy had improved SE (100%) and SP (80%). The specific aims of this Phase II proposal are to: (1) Transition instrument control to a printed circuit board assembly (PCBA) and optimize optical, electrical, and mechanical hardware; (2) Develop production-ready software components including a user interface and ML training and inference; and (3) Integrate instrument hardware and software and evaluate effectiveness of automated adequacy assessment on clinical samples. Completion of these aims will result in a commercial-grade device with demonstrated safety and effectiveness. Upon completion of this project, a limited battery of additional tests, primarily focused on reproducibility and process validation, will fulfill the remaining testing requirements for to receive FDA clearance.
