Lunit (KRX: 328130) and CellCarta on Monday announced a strategic collaboration to accelerate the adoption of AI-enabled digital pathology workflows across translational research, clinical trials and companion diagnostic (CDx) programmes.

This partnership combines Lunit's platform-agnostic AI pathology algorithms with CellCarta's global contract research organisation laboratory network, CDx development capabilities and regulated infrastructure. The companies aim to provide biopharma sponsors with an end-to-end solution that supports biomarker strategy, clinical trial execution and CDx readiness, while offering a faster and more cost-effective interim alternative to traditional in vitro diagnostic (IVD) kit pathways.

The collaboration is designed to support single-site CDx development and launch pathways, complemented by a laboratory developed test (LDT)-based approach for global trials. This model is expected to enable earlier clinical testing access, accelerate launch timelines and generate additional clinical evidence to support subsequent transition to kitted solutions and broader commercialisation.

Under the agreement, Lunit's SCOPE AI digital pathology products will be integrated into CellCarta's workflows, supporting quantitative image analysis, including immunohistochemistry and immune phenotyping, alongside broader biomarker and clinical trial applications. The approach is particularly suited to complex scenarios requiring flexibility across diverse digital pathology platforms and global capacity constraints.

Initial focus areas include enabling faster, data-driven decision-making to de-risk clinical development, strengthening biomarker evidence through AI-powered analysis, supporting platform-agnostic deployment across varied sponsor environments and launching joint pilot programmes to validate operational scalability and performance.

The companies expect to begin with selected pilot projects spanning real-world trial operations and AI image analysis, with plans to expand the collaboration as additional use cases are validated.