This collaboration model aims to adapt to the diverse R&D needs of biopharmaceutical companies, establishing a flexible global companion diagnostic (CDx) development framework through close collaboration and parallel progression, facilitating a more efficient transition from early-stage assay development to commercial diagnostics.
Vista, California, USA and Montreal, CanadaJune 4, 2026 /PRNewswire/ — Recently, Leica Biosystems, a provider of digital pathology and full workflow solutions under Danaher, and CellCarta, one of the world’s leading precision medicine laboratory service providers, have officially upgraded their partnership to a global strategic alliance. They will extend the companion diagnostic (CDx) joint development model, which has been successfully validated in the Chinese market, to biopharmaceutical companies worldwide.
Based on mature operational experience in China, this collaboration introduces a flexible end-to-end CDx development framework that can accommodate diverse regulatory pathways, evolving clinical data, and varying regional market demands. This model will help Chinese biopharmaceutical companies with global expansion strategies optimize R&D processes, support clinical project timelines, and establish more efficient global companion diagnostic commercialization pathways.
Flexible Companion Diagnostic Development Model for the Global Market
The core of this collaboration lies in establishing a collaborative development model that integrates assay development, clinical trial execution, regulatory strategy formulation, and commercial kit planning within a unified framework.
By enabling parallel progression of research-use assay development, clinical testing, and future CDx commercialization, this model helps partners:
- Adjust development strategies in real-time without restarting projects
- Maintain clinical timelines while incorporating new data
- Reduce redundant development efforts across different stages
- Establish clearer, lower-risk, and more efficient regulatory and commercialization pathways
Additionally, the model leverages CellCarta’s innovative “CDx Bridge Model,” combining the development speed of a single-center approach with the scalability of a global laboratory network. This helps biopharmaceutical companies achieve faster market readiness while reducing overall risks in complex R&D projects.
Digital Pathology Capabilities as a Key Differentiator
One of the key differentiators of this collaboration is the ability to integrate advanced digital pathology technologies into the CDx development process where appropriate.
This capability is built on Leica Biosystems’ leadership in digital pathology, including its widely used digital pathology slide scanner (Aperio GT 450 DX), image management systems, and an expanding AI-powered ecosystem.
Combined with CellCarta’s extensive experience in implementing clinical trials on globally standardized digital pathology platforms, these technologies will help achieve:
- Standardized, data-driven pathology workflows
- Scalable image analysis across regions
- Consistent deployment of computational pathology in clinical trials and diagnostic settings
By deeply embedding digital pathology capabilities into the CDx development model, this collaboration will further enhance assay performance and advance data-driven precision medicine on a global scale.
Karan Arora, Senior Vice President, Advanced Assays, AI, and Biopharma Partnerships at Leica Biosystems, stated: “Leica Biosystems is committed to driving innovation in cancer diagnostics, helping innovative precision therapies reach patients more efficiently. By extending the joint development model we have successfully validated with CellCarta in China to the global stage, we can help biopharmaceutical companies more effectively bridge clinical trial execution, regulatory planning, and commercial assay development in a more timely, collaborative, and cost-efficient manner.”
Christopher Ung, Chief Scientific and Commercial Officer at CellCarta, stated: “Pharmaceutical companies are seeking a faster, more flexible, and capital-efficient path to CDx commercialization without compromising quality and compliance. Our collaboration with Leica Biosystems in China has demonstrated that early alignment between clinical trial testing solutions and future kit development pathways can reduce redundant development, safeguard clinical timelines, and build a clear bridge from assay development to commercially available CDx. Extending this collaboration model globally is a natural progression for both parties.”