Cell-based assay for blood-based diagnostics enhances prediction of lung cancer in patients with lung nodules

The iCAP is a tool for blood-based diagnostics that addresses the low signal-to-noise ratio of blood biomarkers by using cells as biosensors. The assay exposes small volumes of patient serum to standardized cells in culture and classifies disease by AI analysis of gene-expression readouts from the cells. It simplifies the complexity of blood into a concise readout in a scalable cell-based assay. We developed the LC-iCAP as a rule-out test for nodule management in CT-based lung cancer screening. The assay achieved an AUC of 0.63 (95% CI 0.50-0.75) in retrospective-blind-temporal validation. When integrated with CT data after validation, it demonstrated potential to reduce unnecessary follow-up procedures by significantly outperforming the Mayo Clinic model with 90% sensitivity, 67% specificity and 95% NPV using an estimated 25% prevalence. Analytical validation established LC-iCAP reproducibility and identified unwanted variation from long-term serum storage suggesting a prospective study design could enhance performance.