Lunit, CellCarta Announce Strategic Collaboration to Accelerate AI-Enabled Digital Pathology for Companion Diagnostic Programs

Partnership combines Lunit's platform-agnostic AI pathology algorithms with CellCarta's global CDx development and laboratory execution to help biopharma teams de-risk assets and accelerate evidence generation and CDx launch pathways.

SEOUL, South Korea and MONTREAL, March 30, 2026 /PRNewswire/ -- Lunit (KRX: 328130), a leading provider of AI for cancer diagnostics and precision oncology, and CellCarta, a leading global contract research organization (CRO) laboratory to the biopharmaceutical industry, today announced a strategic partnership to accelerate 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 commercialization.

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.

Initial focus areas include:

• De-risking: supporting sponsors that want to make faster, data-driven development decisions and reduce uncertainty in clinical trials.
• Translational and clinical workflows: pairing trial execution with AI-powered image analysis to strengthen biomarker evidence packages.
• Platform-agnostic deployment: enabling AI to be used across diverse digital pathology ecosystems aligned to sponsor workflows and operational constraints.
• Real-world global pilot: launching joint pilot programs to validate performance, operational readiness, and scalability.

"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.

"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," said Ehab A. El-Gabry, MD, Chief Medical Officer and Head of Companion Diagnostics at CellCarta.

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

About Lunit

Founded in 2013, Lunit (KRX: 328130) is a global leader on a mission to conquer cancer through AI. Lunit's clinically validated solutions span medical imaging, breast health, and biomarker analysis—supporting earlier detection, smarter treatment decisions, and more precise outcomes across the cancer care continuum. Following the integration of Volpara, Lunit offers a comprehensive suite spanning risk prediction and early detection to precision oncology. Trusted by over 10,000 sites in more than 65 countries, Lunit combines deep medical expertise with continuously evolving datasets to deliver measurable impact for patients, clinicians, and researchers. Headquartered in Seoul with global offices, Lunit is driving the worldwide fight against cancer. Learn more at lunit.io/en.

About CellCarta

CellCarta is a leading global CRO laboratory to the biopharmaceutical industry. With CAP accreditations and CLIA certifications for specific testing methods and facilities in Canada, USA, Belgium, Australia, and China, CellCarta provides a wide range of biomarker testing services and customized solutions to world-renowned pharmaceutical companies. By integrating analytical platforms in immunology, histopathology, proteomics, and genomics, along with sample management and logistics services, CellCarta supports the entire drug development cycle from discovery to late-stage clinical trials. Visit cellcarta.com and connect with us on LinkedIn and X.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding expected collaboration activities, pilot programs, and anticipated benefits. Actual results may differ materially due to risks and uncertainties.

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