CellCarta and Imagene AI expanded their partnership to coordinate AI-powered biomarker and companion diagnostic (CDx) programs through development and regulatory readiness for non-small cell lung cancer. The collaboration focuses on analytical validation, global clinical deployment support, and regulatory support to help move AI models into assay formats that can withstand submission requirements. The teams described two active biomarker programs with unnamed global pharmaceutical partners: one using immunohistochemistry (IHC)-based CDx development and another leveraging Imagene AI’s Lung Prediction Panel built for NSCLC. Executives highlighted that “bringing AI-powered approaches into global drug development requires more than a strong algorithm,” pointing to the practical bottleneck of validation, scaling, and clinical infrastructure.