Abstract
Cancer spatial and temporal heterogeneity fuels resistance to therapies. To realize the routine assessment of cancer prognosis and treatment, we demonstrate the development of an Intelligent Disease Detection Tool (IDDT), a microfluidic-based tumor model integrated with deep learning-assisted algorithmic analysis. IDDT was clinically validated with liquid blood biopsy samples (n = 71) from patients with various types of cancers (e.g., breast, gastric, and lung cancer) and healthy donors, requiring low sample volume (∼200 μl) and a high-throughput 3D tumor culturing system (∼300 tumor clusters). To support automated algorithmic analysis, intelligent decision-making, and precise segmentation, we designed and developed an integrative deep neural network, which includes Mask Region-Based Convolutional Neural Network (Mask R-CNN), vision transformer, and Segment Anything Model (SAM). Our approach significantly reduces the manual labeling time by up to 90% with a high mean Intersection Over Union (mIoU) of 0.902 and immediate results (<2 s per image) for clinical cohort classification. The IDDT can accurately stratify healthy donors (n = 12) and cancer patients (n = 55) within their respective treatment cycle and cancer stage, resulting in high precision (∼99.3%) and high sensitivity (∼98%). We envision that our patient-centric IDDT provides an intelligent, label-free, and cost-effective approach to help clinicians make precise medical decisions and tailor treatment strategies for each patient.