Leica Biosystems and CellCarta expand global companion diagnostic development partnership
Flexible, end‑to‑end CDx development framework integrates digital pathology and clinical workflows to accelerate commercialization
16 Jun 2026
CellCarta and Leica Biosystems have announced a strategic partnership to expand a proven companion diagnostic (CDx) joint development model from China to biopharma sponsors worldwide. The collaboration is designed to accelerate global CDx commercialization by aligning assay development, clinical trial execution, regulatory strategy, and commercial kit planning within a unified, flexible framework that supports diverse biopharma development needs.
Flexible companion diagnostic development model for global biopharma
At the core of the collaboration is a coordinated development model that enables parallel progression across investigational assay development, clinical testing, and future CDx commercialization. This unified structure is designed to help sponsors:
- Adapt development strategies in real time without resetting programs
- Maintain clinical timelines while incorporating emerging data
- Reduce duplicated work across development stages
- Establish a clearer, lower-risk and more streamlined path to registration and commercialization
CellCarta CDx Bridge Model supports precision medicine programs
The CDx development framework is further enabled by CellCarta’s CDx Bridge Model, an innovative companion diagnostics strategy designed to help accelerate precision medicine programs. The CDx Bridge Model combines the speed of a single-site approach with the scalability of a global laboratory network, enabling biopharma partners to achieve faster market readiness while helping to de-risk complex biopharma programs.
By integrating this model into the joint Leica Biosystems–CellCarta framework, biopharma sponsors gain access to a coordinated global infrastructure that supports the transition from early-stage assays to commercial diagnostics, while maintaining alignment with regional regulatory and market requirements.
Digital pathology leadership as a differentiator in CDx development
A key differentiator of the partnership is the ability to integrate advanced digital pathology into the CDx workflow, when appropriate. This capability is anchored in Leica Biosystems’ presence in digital pathology, including its Aperio scanners (for example, GT450) and IMS (HALO, HALO Dx) platform, as well as an expanding AI-enabled ecosystem.
Together with CellCarta’s experience implementing a globally standardized digital pathology platform for clinical trials, these technologies are intended to enable:
- Standardized, data-driven pathology workflows
- Scalable integration of image analysis across geographies
- Consistent deployment of computational pathology in both clinical trials and diagnostic settings
By embedding digital pathology directly into the CDx development model, the Leica Biosystems and CellCarta partnership is designed to strengthen assay performance and support the advancement of data-driven precision medicine on a global scale.
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Frequently asked questions
How does the Leica Biosystems and CellCarta strategic partnership support global companion diagnostic (CDx) commercialization for biopharma sponsors?
The strategic partnership between Leica Biosystems and CellCarta is designed to accelerate global CDx commercialization for biopharma sponsors. Built on operational success in China, the collaboration introduces a flexible, end-to-end CDx development framework that aligns investigational assay development, clinical trial execution, regulatory strategy, and commercial kit planning within a unified structure.
This coordinated model supports multiple regulatory pathways, evolving clinical data, and regional market requirements, helping biopharma sponsors streamline development activities, maintain clinical timelines, reduce duplicated work, and establish a clearer, lower-risk path to global CDx registration and commercialization.
What is CellCarta’s CDx Bridge Model and how does it enable precision medicine and biopharma programs?
CellCarta’s CDx Bridge Model is an innovative companion diagnostics strategy that underpins the joint Leica Biosystems–CellCarta CDx development framework. It combines the speed of a single-site approach with the scalability of a global laboratory network, enabling biopharma partners to achieve faster market readiness while helping to de-risk complex biopharma programs.
By integrating the CDx Bridge Model into the partnership, biopharma sponsors gain access to a coordinated global infrastructure that supports the transition from early-stage assays to commercial diagnostics, while maintaining alignment with regional regulatory and market requirements and advancing precision medicine programs.
How does digital pathology, including Leica Biosystems’ Aperio scanners and AI-enabled ecosystem, differentiate the Leica Biosystems–CellCarta CDx development model?
Digital pathology leadership is a key differentiator of the Leica Biosystems–CellCarta partnership in companion diagnostic development. Leica Biosystems contributes advanced digital pathology capabilities, including its Aperio scanners (for example, GT450) and IMS (HALO, HALO Dx) platform, as well as an expanding AI-enabled ecosystem.
Combined with CellCarta’s experience implementing a globally standardized digital pathology platform for clinical trials, these technologies enable standardized, data-driven pathology workflows, scalable integration of image analysis across geographies, and consistent deployment of computational pathology in both clinical trials and diagnostic settings.
By embedding digital pathology directly into the CDx development model, the partnership is designed to strengthen assay performance and support the advancement of data-driven precision medicine on a global scale.