Lunit, CellCarta Announce Global Alliance to Expand Access to Digital Pathology AI for Clinical Trials

SEOUL, South Korea and MONTREAL, Sept. 24, 2025 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI for cancer diagnostics and biomarkers for oncology therapeutics, today announced a strategic partnership with CellCarta, a globally recognized provider of CRO laboratory services for pharmaceutical research and development. Under the partnership, Lunit's AI pathology solutions will be offered as part of CellCarta's services for global clinical trials, making it easier for pharma sponsors to adopt AI-powered analysis within existing trial workflows.

CellCarta operates CAP-accredited/CLIA-certified laboratories across North America, Europe, and Asia, and is widely recognized for its expertise in pathology, biomarker development, and global clinical trial support across oncology and immunology. The company has participated in more than 1,000 clinical studies—including 75 Phase III PMA trials—developed over 250 unique IHC assays, and performs more than 100,000 IHC stainings annually.

The collaboration aims to broaden access to the Lunit SCOPE^® suite, Lunit's digital pathology AI solution, and deliver faster, more scalable insights into tumor biology through the analysis of H&E and IHC whole slide images. These insights help identify patients likely to benefit from specific therapies, support biomarker development, and ultimately advance precision oncology and drug development.

Both CellCarta and Lunit have focused on enabling immune phenotype analysis — CellCarta, via IHC stains including panCK and CD8, and Lunit, via AI analysis of H&E with its Lunit SCOPE IO^® product. Each service aims to enable the use of quantitative immune phenotyping within clinical trials. One benefit of the partnership is access to Lunit SCOPE IO, within CellCarta's global, best-in-class clinical infrastructure — Lunit's AI solution that quantifies tumor-infiltrating lymphocytes and classifies immune phenotypes from H&E whole slide images.

The Lunit SCOPE suite includes AI-powered tools such as SCOPE IO, SCOPE PD-L1, and SCOPE uIHC. Several of the world's largest pharmaceutical companies have already published their use of these solutions in research settings to support biomarker-driven research and inform patient selection strategies in oncology trials.

"As more biopharma companies turn to AI-powered pathology to streamline biomarker development and patient selection, the demand for scalable, clinically validated solutions is rapidly growing," said Yannick Waumans, Director of Digital Pathology Solutions at CellCarta. "Partnering with Lunit allows us to offer our clients a powerful and proven AI platform that integrates seamlessly into global clinical trial workflows."

"We're thrilled to partner with CellCarta, a trusted CRO with a strong global presence and impressive leadership in digital pathology real-world deployment," said Brandon Suh, CEO of Lunit. "This collaboration gives more clinical research teams a way to harness the power of AI in pathology, and we look forward to seeing its impact on trials and, ultimately, on patients."

This past June, at a workshop held at CellCarta's Antwerp site, Lunit presented how its AI-powered pathology platform can support drug development through deep learning analysis of H&E and IHC images—highlighting applications such as tumor microenvironment profiling, genomic mutation prediction, and biomarker quantification across cancer types.

About Lunit
Founded in 2013, Lunit (KRX:328130.KQ) is a global leader in AI for cancer diagnostics and therapeutics. With a mission to conquer cancer through AI, Lunit develops AI-powered solutions for medical imaging and biomarker analysis to enable precise diagnosis and personalized treatment. Lunit's FDA-cleared Lunit INSIGHT suite supports cancer screening at over 7,000 medical institutions in more than 65 countries, while Lunit SCOPE is used in research partnerships with global pharma giants focused on biomarker development and companion diagnostics. Lunit clinical studies have been featured in top-tier journals—including The Lancet Digital Health and Journal of Clinical Oncology—and presented at major conferences such as ASCO and RSNA. Headquartered in Seoul with global offices, Lunit is driving the worldwide fight against cancer. Learn more at lunit.io.

About CellCarta
CellCarta is a leading global contract research organization (CRO) serving the biopharmaceutical industry. With CAP accreditations and CLIA certifications for advanced assays and fully integrated quality management systems across Canada, the United States, Belgium, Australia and China, the company delivers comprehensive biomarker testing services and tailored solutions to the world's leading pharmaceutical companies. CellCarta's integrated platforms in immunology, histopathology, proteomics and genomics platforms, together with its sample management and logistics systems, enable the company to provide clients comprehensive, full-cycle support throughout the drug discovery process, from early-stage research to late-stage clinical trials.

SOURCE Lunit