The collaboration pairs AI pathology algorithms with global laboratory infrastructure to help biopharma teams speed up evidence generation and diagnostic launch timelines.

Lunit and CellCarta announced a partnership aimed at accelerating the adoption of artificial intelligence (AI)-enabled digital pathology workflows across translational research, clinical trials, and companion diagnostic (CDx) programs.

The collaboration combines Lunit’s platform-agnostic AI pathology algorithms with CellCarta’s global pathology network, CDx execution capabilities, and regulated laboratory infrastructure. Together, the companies plan to integrate Lunit SCOPE AI digital pathology products within CellCarta workflows to support biomarker strategy, quantitative image analysis—including quantitative immunohistochemistry and immune phenotyping—clinical trial testing, and CDx readiness.

A key focus of the partnership is providing biopharma sponsors with an alternative to the traditional in vitro diagnostic kit pathway. The collaboration is designed to support single-site CDx development and launch pathways coupled with a lab developed test-based support strategy for global trials, potentially enabling earlier clinical testing access and accelerated launch timelines. Evidence generated through this approach can also support future transfer to a kitted solution and broader global commercialization.

“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,” says Brandon Suh, chief executive officer of Lunit, in a release.

Addressing Complexity in Global Trials

The partnership is specifically designed to address high-complexity or structurally constrained scenarios where platform compatibility, footprint limitations, or global capacity constraints require greater flexibility. Initial focus areas include biomarker strategy development, AI-assisted quantitative image analysis, and CDx launch readiness for programs operating across multiple geographies.

“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,” says Dusty Tenney, chief executive officer of CellCarta, in a release.

Ehab A. El-Gabry, MD, chief medical officer and head of companion diagnostics at CellCarta, framed the collaboration in the context of broader industry trends. “Digital pathology and validated AI algorithms are becoming increasingly central to CDx development—improving consistency, scalability, and reproducibility across global programs. This collaboration is designed to strengthen how biopharma teams generate actionable tissue biomarker evidence and prepare for regulatory and commercialization requirements,” he says in a release.

The companies expect to begin with jointly selected pilot opportunities designed to demonstrate combined capability across real-world workflows, including trial operations and AI image analysis. Lunit and CellCarta plan to expand the collaboration as additional use cases are validated.

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