Lunit and CellCarta Collaborate to Expand AI Pathology in CDx Development

The collaboration brings together Lunit’s platform-agnostic AI pathology capabilities with CellCarta’s extensive global pathology network, CDx execution expertise, and regulated laboratory operations. The aim of the partnership is to expand the use of AI-enabled digital pathology in companion diagnostic (CDx) programs across translational research and clinical trial environments. 

Together, the partners will work to enable streamlined single-site CDx development and launch pathways, while leveraging a laboratory developed test (LDT) strategy to support global clinical trials. This approach is designed to remain complementary to in vitro diagnostic (IVD) manufacturers and platform partners, helping to extend access and flexibility across diverse development and commercialization settings.

As part of the collaboration, Lunit SCOPE AI digital pathology products will be integrated into CellCarta workflows to support biomarker strategy, quantitative image analysis, and clinical trial testing. This includes applications such as quantitative immunohistochemistry (IHC) and immune phenotyping, with the goal of advancing companion diagnostic (CDx) readiness across development programs.

The platform-agnostic approach is designed to address high-complexity or structurally constrained scenarios where flexibility is required due to compatibility, instrument footprint, or global capacity considerations. In certain programs, this model may enable earlier access to clinical testing and faster launch timelines, while generating additional clinical evidence after an initial single-site launch to support eventual transfer to a kitted solution and broader commercialization.

The partners describe objectives that include de-risking by enabling faster, data-driven development decisions; pairing trial execution with AI-powered image analysis to strengthen biomarker evidence packages; and supporting deployment aligned to sponsor workflows and operational constraints. They expect to begin with jointly selected pilot opportunities that demonstrate combined capability across real-world operations and AI image analysis, with expansion as additional use cases are validated.

“Biopharma is moving quickly toward AI-enabled pathology, but scalable adoption requires interoperability and operational readiness. Working with CellCarta, we plan to deliver an integrated approach that supports real-world trial workflows today while building a bridge to future commercialization models as evidence and program needs evolve,” said Brandon Suh, CEO of Lunit.

"Our customers want speed without sacrificing rigor, and they want optionality. By combining CellCarta's global CDx execution capabilities with Lunit's AI pathology solutions, we aim to help sponsors generate high-quality evidence efficiently and move faster on the programs that deserve to advance," said Dusty Tenney, CEO of CellCarta.

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