Global Framework Integrates Digital Pathology for Companion Diagnostic Development

Built on operational success in China, the flexible, end‑to‑end framework is designed to accommodate diverse regulatory pathways, evolving clinical data, and regional market requirements. The approach is further enabled by CellCarta’s CDx Bridge Model, which combines the speed of a single‑site approach with the scalability of a global laboratory network to help partners achieve faster market readiness while de‑risking complex programs.

At the core is a unified structure that aligns assay development, clinical trial execution, regulatory strategy, and commercial kit planning. By allowing parallel progression across investigational assay development, clinical testing, and future CDx commercialization, the model is intended to help sponsors adapt strategies in real time without resetting programs. It is also designed to maintain clinical timelines while incorporating emerging data, reduce duplicated work across stages, and establish a clearer, lower‑risk path to registration and commercialization.

Digital pathology integration is a key differentiator within the 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 an expanding AI‑enabled ecosystem. Combined with CellCarta’s experience implementing a globally standardized digital pathology platform for clinical trials, the collaboration aims to enable standardized, data‑driven pathology workflows, scalable image analysis across geographies, and consistent deployment of computational pathology in both clinical trials and diagnostic settings.

The partners state that embedding digital pathology directly into the development model strengthens assay performance and supports the advancement of data‑driven precision medicine. Overall, the expanded framework is intended to streamline development activities, support clinical timelines, and create a more efficient path from early‑stage assays to commercial diagnostics and global CDx availability.

“Leica Biosystems is committed to advancing cancer diagnostics and helping bring innovative companion precision therapies to patients more efficiently. 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,” said Karan Arora, SVP Advanced Assays, AI and Biopharma Partnerships, Leica Biosystems.

“Pharma sponsors are looking for a CDx commercialization path that is faster, more flexible, and more capital-efficient without compromising quality and regulatory rigor. 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,” said Christopher Ung, Chief Scientific Business Officer at CellCarta.

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