CellCarta and Imagene AI expanded their partnership to support AI-powered biomarker and companion diagnostic (CDx) programs across the full development pathway, from analytical validation to regulatory readiness. The collaboration includes programs in non-small cell lung cancer (NSCLC), including an H&E-based lung prediction panel used for biomarker development. The companies framed the bottleneck as not just algorithm performance, but the ability to validate assays, deploy them in global trials, and navigate regulatory requirements. They said the partnership coordinates these steps to move AI-derived biomarkers into clinical evidence generation. For CDx developers and pharma sponsors, the expanded structure is a practical blueprint for how to translate explainable image-analysis models into regulatory-grade tests. Imagene AI and CellCarta said two programs with unnamed global pharma partners are already active, one focused on IHC-based CDx development and another using Imagene’s H&E prediction panel.