Designed to adapt to diverse biopharma development needs, and enabled by close collaboration and parallel execution, the partnership introduces a flexible global framework for CDx development intended to support more efficient progression from early-stage assays to commercial diagnostics.
MONTREAL, CANADA, June 01 2026 – Life Science Newswire – CellCarta, a leading global precision medicine laboratory services provider and Leica Biosystems, a Danaher company and a global leader in end-to-end anatomic and digital pathology solutions, today announced a strategic partnership to bring a proven companion diagnostic (CDx) joint development model from China to biopharma sponsors globally.
Built on operational success in China, the partnership brings forward a flexible, end-to-end CDx development framework designed to accommodate diverse regulatory pathways, evolving clinical data, and regional market requirements. The model is intended to help biopharma sponsors to streamline development activities, support clinical timelines, and establish a more efficient path to global CDx commercialization.
Flexible CDx Development for Global Development
At the core of the collaboration is a coordinated development model that aligns assay development, clinical trial execution, regulatory strategy, and commercial kit planning within a unified structure.
By enabling parallel progression across investigational assay development, clinical testing, and future CDx commercialization, the model 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 clear, lower-risk and more streamlined path to registration and commercialization
The model is further enabled by CellCarta’s CDx Bridge Model, which is an innovative companion diagnostics strategy designed to help accelerate precision medicine programs by combining 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.
Digital Pathology Leadership as a Differentiator
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’ leadership in digital pathology, including its widely adopted Aperio Scanners (i.e., GT450) and IMS (HALO, HALO Dx) platform and 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 partnership strengthens assay performance while supporting the advancement of data-driven precision medicine on a global scale.
Executive Commentary
"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, 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."