Leica Biosystems is a global leader in anatomic pathology, offering the most comprehensive portfolio of solutions and one of the largest global installed bases of IHC instruments. We partner with leading pharmaceutical companies to develop and quickly integrate innovative diagnostics into anatomic pathology laboratories worldwide.
Scale Access to Therapies Faster with Our Broad CDx Capabilities
Flexible CDx Development
- Develop fit-for-purpose assays leveraging our experience from 1,300 IVDs globally, including IVDR compliance for all IHC primary antibodies
- Optimize timelines with flexible and modular development & robust QMS
- Advance diagnostic programs from research to clinical to commercial via our CAP CLIA lab
Broad Research-to-Clinical Portfolio
- Access to 11K antibodies through Leica and Danaher’s Abcam
- Expand to multi-modal CDx via access to other Danaher companies: Beckman Coulter and Cepheid
- Reduce variability by leveraging our leadership in digital pathology and AI partnerships
Fast Commercial Scale-Up
- Enable patient access to novel therapies via our 8,000+ IHC instruments & presence in all top US cancer centers
- Accelerate adoption by partnering with our 1,300+ commercial associates
- Ensure CDx continuity via our robust supply chain serving 100+ countries
Supported by proven project management experience |
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Comprehensive and Seamless CDx Co-Development Process
What's New
Collaboration Expansion to develop an IHC Assay and Image Analysis Algorithm for TROP2 NMR
Leica Biosystems, AstraZeneca, and Daiichi Sankyo are expanding their strategic collaboration to develop an IHC assay and image analysis algorithm for the TROP2 NMR biomarker in non-small cell lung cancer for use as a research tool.
For Research Use Only. Not for use in diagnostic procedures.
Expanding Our Partnership to Bring Our Flexible CDx Development Model Worldwide
Leica Biosystems and CellCarta are bringing an established companion diagnostics (CDx) joint development model to biopharma sponsors worldwide—aligning assay development, clinical trial execution, regulatory strategy, and commercial planning in one framework. The result: a lower-risk, flexible path from early-stage assay to global CDx.
Leica Biosystems and Indica Labs Announce Significant Strategic Investment and Creation of Digital Pathology Platform
Combining leading hardware and software is expected to provide a compelling solution for digital pathology users across the full translational medicine paradigm, from early biomarker discovery to clinical trials, and through to routine diagnostics.
