Lunit and CellCarta are starting a strategic partnership to accelerate adoption of AI-enabled digital pathology workflows. Such approaches are intended to be used across translational research, clinical trials, and companion diagnostic (CDx) programs.

Lunit, headquartered in Seoul, South Korea, provides AI services for cancer diagnostics and precision oncology. Montreal-based CellCarta is a global contract research organization (CRO) laboratory to the biopharmaceutical industry.

What Lunit and CellCarta are Seeing

The two companies say they have observed biopharma teams increasingly seeking end-to-end approaches pairing CDx development with digital pathology. Other elements in this relationship include not only launch readiness, but also, validated AI algorithms.

Compared with traditional in-vitro diagnostic kit pathways, sponsors now need faster, more cost-effective solutions, even on an interim basis. In an environment where some programs may not advance, the ability to make earlier decisions across broad pipelines is essential.

In this partnership, Lunit and CellCarta are aiming to support single-site CDx development and launch pathways. They will couple this with a lab developed test-based support strategy for global trials.

How AI Will Help Acceleration

Lunit’s platform-agnostic AI pathology capabilities will support biomarker strategy, quantitative image analysis, clinical trial testing, and CDx readiness.

“Biopharma is moving quickly toward AI-enabled pathology, but scalable adoption requires interoperability and operational readiness,” said Lunit CEO Brandon Suh. “We plan to deliver an integrated approach that supports real-world trial workflows while building a bridge to future commercialization models.”

“Our customers want speed without sacrificing rigor, and they want optionality,” said CellCarta CEO Dusty Tenney. “By combining CellCarta’s global CDx execution capabilities with Lunit’s AI pathology solutions, we aim to help sponsors generate high-quality evidence.”

Lunit and CellCarta plan to begin with jointly selected pilot opportunities that demonstrate capability in real-world workflows. After that, they will expand their collaboration as additional use cases are validated.