The biopharma CRO CellCarta and cancer diagnostic company Leica Biosystems have announced the expansion of an agreement from China to bring a proven companion diagnostic (CDx) joint development model to biopharma sponsors globally.
Having achieved operational success in China, the expanded partnership will aim to introduce a flexible, end-to-end CDx development framework designed to accommodate diverse regulatory pathways, evolving clinical data and regional market requirements.
The pair said that the model will be intended to help biopharma sponsors to streamline development activities, support clinical timelines and establish a more efficient path to global CDx commercialisation.
The coordinated development model comprises assay development, clinical trial execution, regulatory strategy and commercial kit planning, all within a unified structure.
The duo said that this all-in-one model would help sponsors with adapting development strategies in real time without the need to reset programmes and maintain clinical timelines while incorporating emerging data.
This, the pair explained, would help establish a clear, lower-risk and more streamlined path to registration and commercialisation for their customers.
The model is further supported by 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, enabling biopharma partners to achieve faster market readiness and helping to de-risk complex biopharma programmes.
CellCarta highlighted that a key differentiator of its partnership is the CDx model's ability to integrate advanced digital pathology into its workflow (when appropriate).
This capability is supported by Leica Biosystems' leadership in digital pathology, which includes its widely adopted Aperio Scanners (such as the GT450), the IMS platform (including HALO and HALO Dx) and an expanding AI-enabled ecosystem.
Additionally, CellCarta brings its expertise in implementing a globally standardised digital pathology platform for clinical trials.
"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 commercialisation path that is faster, more flexible and more capital-efficient without compromising quality and regulatory rigour," added 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."