Lunit, a leading provider of AI for cancer diagnostics and precision oncology, and CellCarta, a leading global contract research organisation (CRO) laboratory to the biopharmaceutical industry, announced a strategic partnership to accelerate the adoption of AI-enabled digital pathology workflows across translational research, clinical trials and companion diagnostic (CDx) programs.
Biopharma teams increasingly seek an end-to-end approach that pairs CDx development and launch readiness with digital pathology and validated AI algorithms. At the same time, sponsors often need an interim solution that is faster and more cost-effective than a traditional in vitro diagnostic (IVD) kit pathway, enabling earlier decision-making across broad pipelines where many programs may not advance.
The collaboration is designed to provide this bridge by combining Lunit's versatile, platform-agnostic AI pathology capabilities with CellCarta's global pathology network, CDx execution capabilities, and regulated laboratory infrastructure. Together, the companies aim to support single-site CDx development and launch pathways, coupled with a lab-developed test (LDT) based support strategy for global trials, while remaining complementary to established IVD manufacturers and platform partners. In certain programs, this approach can enable earlier clinical testing access and accelerated launch timelines, while also generating additional clinical evidence after an initial single-site launch to support future transfer to a kitted solution and broader global commercialisation.
Under the collaboration, Lunit and CellCarta plan to integrate Lunit SCOPE AI digital pathology products within CellCarta workflows to support biomarker strategy, quantitative image analysis, including quantitative immunohistochemistry (IHC) and immune phenotyping, clinical trial testing, and CDx readiness—especially in high-complexity or structurally constrained scenarios where platform compatibility, footprint limitations, or global capacity constraints require greater flexibility.
