CellCarta and Leica Biosystems Expand Global CDx CRO Partnership to Accelerate Companion Diagnostic Commercialization

• CellCarta, a leading global CRO laboratory services provider, and Leica Biosystems, a Danaher company and global leader in anatomic and digital pathology solutions, have announced the global expansion of a companion diagnostic joint development model first proven in China, offering biopharma sponsors a more coordinated and capital-efficient path from early-stage assay development to commercial CDx registration.

• The partnership introduces CellCarta’s CDx Bridge Model within a unified framework that aligns assay development, clinical trial execution, regulatory strategy, and commercial kit planning — with digital pathology capabilities anchored by Leica Biosystems’ Aperio slide scanners, image management systems, and AI-enabled analysis tools embedded directly into the CDx workflow.

CellCarta, a leading global CRO providing precision medicine laboratory services to the biopharmaceutical industry, and Leica Biosystems, a Danaher company and global leader in end-to-end anatomic and digital pathology solutions, announced on May 30, 2026, the global expansion of a proven companion diagnostic joint development model originally established and operationally validated in China. The partnership is designed to offer biopharma sponsors a flexible, end-to-end CDx development framework that accommodates diverse regulatory pathways, evolving clinical data, and regional market requirements across international markets.

At the core of the collaboration is a coordinated development model structured around CellCarta’s CDx Bridge Model — an innovative companion diagnostics strategy that combines the speed of a single-site approach with the scalability of a global laboratory network. The framework enables parallel progression across investigational assay development, clinical testing, and commercial CDx planning, allowing sponsors to adapt development strategies in real time without resetting programs, maintain clinical timelines as new data emerge, and reduce duplicated work across development stages. The result is intended to be a lower-risk, more streamlined path to registration and commercialization for CRO clients managing complex precision medicine programs.

A key differentiator of the model is the integration of advanced digital pathology directly into the CDx workflow. Leica Biosystems contributes its Aperio GT 450 DX slide scanner, Aperio HALO AP and HALO AP DX image management software, and its expanding AI-enabled ecosystem to the framework. Combined with CellCarta’s experience deploying a globally standardized digital pathology platform for clinical trials, the integrated capability enables standardized, data-driven pathology workflows, scalable image analysis across geographies, and consistent deployment of computational pathology across both clinical trial and diagnostic settings. These capabilities are intended to strengthen assay performance and advance data-driven precision medicine at scale.

For biopharma sponsors, the expansion directly addresses a persistent structural challenge in CDx development: the disconnect between clinical trial assay execution and the commercial kit development path. By aligning these activities within a single coordinated CRO framework from the outset, the partnership reduces the rework and timeline risk that typically arise when regulatory requirements shift mid-program or when sponsors must transition from a clinical assay to a commercial diagnostic without prior alignment on kit architecture or manufacturing requirements.

“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 Biosystems 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.”

Christopher Ung, Chief Scientific Business Officer, CellCarta