The partnership combines Lunit’s platform-agnostic AI pathology algorithms with CellCarta’s global CDx development and laboratory execution, enabling biopharmaceutical teams to de-risk assets and accelerate evidence generation and CDx launch pathways.
Seoul, South Korea, Montreal, March 30, 2026 /PRNewswire/ — Lunit (KRX: 328130), a leading provider of AI for cancer diagnostics and precision oncology, and CellCarta, a global contract research organization (CRO) laboratory to the biopharmaceutical industry, today announced a strategic partnership to accelerate the adoption of AI-enabled digital pathology workflows across translational research, clinical trials, and companion diagnostics (CDx) programs.
Lunit x Cell Carta
Biopharmaceutical teams are increasingly seeking end-to-end approaches that combine CDx development and launch readiness with digital pathology and validated AI algorithms. At the same time, sponsors often require interim solutions that are faster and more cost-effective than the traditional in vitro diagnostic (IVD) kit route and enable earlier decision-making across broad pipelines where many programs may not advance.
This collaboration is designed to provide this bridge by combining Lunit’s versatile, platform-independent AI pathology capabilities with CellCarta’s global pathology network, CDx execution capabilities, and regulated laboratory infrastructure. Together, the companies aim to support a single-center CDx development and launch pathway, coupled with a laboratory-developed testing (LDT)-based support strategy for global clinical trials, while maintaining complementary relationships with established IVD manufacturers and platform partners. For certain programs, this approach can enable early clinical trial access and accelerated launch schedules, while generating additional clinical evidence after initial single-site launch to support transition to future kitted solutions and broader global commercialization.
Under this partnership, Lunit and CellCarta plan to integrate Lunit SCOPE AI digital pathology products within CellCarta workflows to support biomarker strategies, quantitative image analysis including quantitative immunohistochemistry (IHC) and immunophenotyping, clinical trial testing, and CDx readiness. Particularly for high complexity or architecturally constrained scenarios where platform compatibility, footprint limitations, or global capacity constraints require greater flexibility.
The initial focus areas are:
- risk avoidance: Supporting sponsors who want to make data-driven development decisions faster and reduce uncertainty in clinical trials.
- Translational and clinical workflow: Combining clinical trial execution and AI-powered image analysis to enhance the biomarker evidence package.
- Platform-independent deployment: Enabling the use of AI across a diverse digital pathology ecosystem to suit sponsors’ workflows and operational constraints.
- Real world global pilot: Initiate a joint pilot program to validate performance, operational readiness, and scalability.
“Biopharma is rapidly moving toward AI-enabled pathology, but scalable adoption requires interoperability and operational readiness. Together with CellCarta, we plan to deliver an integrated approach that supports today’s real-world clinical trial workflows while providing 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 also want optionality. By combining CellCarta’s global CDx execution capabilities with Lunit’s AI pathology solutions, we aim to help sponsors efficiently generate high-quality evidence and advance deserving programs faster,” said Dusty Tenney, CEO of CellCarta.
“Digital pathology and validated AI algorithms are becoming central to CDx development, improving consistency, scalability, and reproducibility across global programs. This collaboration aims to enhance the way biopharmaceutical teams generate actionable tissue biomarker evidence and prepare for regulatory and commercialization requirements,” said Ehab A. El-Gabry, MD, Chief Medical Officer and Companion Diagnostics Director at CellCarta.
The companies will begin by jointly selecting pilot opportunities to demonstrate integrated capabilities across real-world workflows, such as trial operations and AI image analysis, and plan to expand their collaboration as additional use cases are validated.
About Lunit
Founded in 2013, Lunit (KRX: 328130) is a global leader on a mission to defeat cancer through AI. Lunit’s clinically validated solutions span medical imaging, breast health, and biomarker analysis to support early detection, smarter treatment decisions, and more accurate outcomes across the cancer treatment continuum. After integrating Volpara, Lunit will offer a comprehensive suite ranging from risk prediction and early detection to precision oncology. Trusted by more than 10,000 facilities in more than 65 countries, Lunit combines deep medical expertise with continuously evolving datasets to deliver measurable impact for patients, clinicians, and researchers. Lunit is headquartered in Seoul and has offices around the world, advancing the global fight against cancer. Learn more here lunit.io/ja.
About Sercarta
CellCarta is a leading global CRO laboratory in the biopharmaceutical industry. With CAP certification and CLIA certification for specific testing methods and facilities in Canada, the United States, Belgium, Australia, and China, CellCarta provides a wide range of biomarker testing services and customized solutions to world-renowned pharmaceutical companies. CellCarta supports the entire drug development cycle from discovery to late-stage clinical trials by integrating immunology, histopathology, proteomics, and genomics analytical platforms with sample management and logistics services. visit cellcarta.com Connect with us on LinkedIn and X.
Forward-looking statements
This press release contains forward-looking statements, including statements regarding anticipated collaboration activities, pilot programs and anticipated benefits. Actual results may differ materially due to risks and uncertainties.
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