Leica Biosystems and CellCarta Expand Collaborative Companion Diagnostic Development Model to Accelerate Commercialization Globally

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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, May 29, 2026 /PRNewswire/ -- 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: 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 plat...

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