New framework supports companion diagnostics development

Leica Biosystems and CellCarta have announced a global collaboration to support more efficient development of companion diagnostics (CDx) for precision medicine applications.

Building on a joint development model established in China, the partnership will provide biopharmaceutical companies with a coordinated approach that links assay development, clinical trial testing, regulatory planning and future diagnostic commercialisation.

The framework is designed to help streamline CDx programmes by enabling closer alignment between early-stage assay development and commercial diagnostic requirements, reducing duplication and supporting faster progression towards regulatory approval.

Karan Arora, SVP Advanced Assays, AI and Biopharma Partnerships at Leica Biosystems, said: “By expanding our successful China joint development model globally with CellCarta, we aim to help biopharma sponsors connect clinical trial execution, regulatory planning and commercial diagnostic development in a more coordinated way.”

A key element of the collaboration is the integration of digital pathology capabilities, combining Leica Biosystems’ expertise in anatomic and digital pathology with CellCarta’s experience in clinical trial laboratory services. This approach aims to support standardised pathology workflows, scalable image analysis and more consistent deployment of computational pathology across global studies.

The partners will initially focus on expanding this collaborative model internationally, supporting pharmaceutical companies developing targeted therapies that require companion diagnostic testing.

More information online