CellCarta, a global leader in precision medicine laboratory services, and Leica Biosystems have announced a strategic partnership aimed at exporting a companion diagnostic (CDx) development model—already proven in China—to biopharma sponsors worldwide.
The collaboration introduces a flexible, end-to-end CDx framework designed to adapt to shifting regulatory environments, evolving clinical datasets, and regional market requirements. The companies say the approach is intended to streamline development, keep clinical programs on track, and accelerate the path to global CDx commercialization.
At the center of the model is a tightly coordinated development structure that integrates assay development, clinical trial execution, regulatory planning, and commercial kit strategy into a single unified workflow. By running these processes in parallel rather than sequentially, the system is designed to reduce duplication, preserve timelines as new data emerges, and lower overall development risk.
CellCarta’s CDx Bridge Model plays a key enabling role, combining what the company describes as the speed of a single-site setup with the scalability of a global laboratory network. The goal is to support faster market readiness while reducing operational complexity across multinational biopharma programs.
A major pillar of the partnership is the integration of digital pathology technologies into CDx workflows where appropriate. Leica Biosystems brings its established imaging and analytics ecosystem, including Aperio GT450 scanner and its HALO and HALO Dx platforms, alongside emerging AI-enabled tools.
CellCarta contributes experience in deploying standardized digital pathology systems across global clinical trials.
Together, the companies say this integration will support more consistent pathology workflows, scalable image analysis across regions, and broader adoption of computational pathology in both clinical research and diagnostics.
“Leica Biosystems is committed to advancing cancer diagnostics and helping bring innovative companion precision therapies to patients more efficiently,” said Karan Arora, SVP Advanced Assays, AI and Biopharma Partnerships at Leica Biosystems.
“By expanding our successful China joint development model globally with CellCarta, we can help biopharma sponsors connect clinical trial execution, regulatory planning, and commercial kit development in a more timely, coordinated, and cost-effective way.”
“Pharma sponsors are looking for a CDx commercialization path that is faster, more flexible, and more capital-efficient without compromising quality and regulatory rigor,” said Christopher Ung, Chief Scientific Business Officer at CellCarta.
“Our work with Leica in China demonstrates how early alignment between the clinical trial assay and the future kit-development path can reduce rework, protect clinical timelines, and create a clear bridge from assay development to commercial CDx availability. Taking this collaborative model global is a natural extension of Leica Biosystems and CellCarta's partnership.”
