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Companion Diagnostics

Companion Diagnostics: Cutting Edge Collaboration

Partner with the Leica Biosystems Companion Diagnostics (CDx) team for your next diagnostic development project. Our CDx team collaborates with leading biotechnology and pharmaceutical companies. Together, we develop and ultimately commercialize cutting-edge diagnostic test solutions that help identify patients who are likely to benefit from our partners’ emerging therapies, a critical element of personalized medicine.

We are uniquely positioned to drive personalized healthcare by ensuring patients receive a timely and accurate diagnosis, a critical part of VISION24, our vision statement.

  • Our in vitro diagnostic (IVD)CDx products are developed by a CDx team with extensive diagnostics and pharmaceutical industry experience.
  • Likewise, assay development is carried out under Design Control standards. A standardized process also allows for consistent output and robust diagnostic products.
  • Each CDx project is assigned to a cross-functional team that works closely with our Pharma Partners throughout the IVD development process.

Clinical Affairs

Leica Biosystems has established a dedicated CDx Clinical Affairs team. Our team:

  • Has IVD industry expertise to ensure successful coordination and execution of global clinical programs
  • Collaborates with our partners
  • Supports clinical trials in key markets such as Asia, Europe and the Americas

Additionally, our Assay Development team has the flexibility to work with contract research organizations (CROs) and trial sites selected by our Pharma Partners. We transfer CDx assays with the required country-specific labeling to CRO labs while adhering to a rigorous evaluation process.

Regulatory Approval

Leica Biosystems has a dedicated regulatory team. Our team:

  • Includes professionals with deep experience in CDx development.
  • Uses an established regulatory infrastructure that lets us support Pharma Partners worldwide.
  • Takes a global lifecycle approach to regulatory planning and execution.
  • Has extensive experience with drug and device submissions in countries across the world.

Moreover, our strategies are flexible and responsive to the Pharma Partner’s development schedule and objectives.

Image Analysis

The field of tissue diagnostics is moving toward using computational analysis to make accurate diagnosis. The CDx team:

  • Incorporates the technology of Pathology Imaging (Aperio), a leader in image analysis and algorithmic interpretation.
  • Devises well-integrated computational solutions as part of the diagnostic workflow.


CDx products are launched via a robust and tested process designed with Danaher Business System (DBS) tools, the same tools which provide lean and commercial support to numerous companies across a variety of industries.

In addition, our shared services team of Market Access professionals has expertise in:

  • Health Policy
  • Payer relations (Government and Private)
  • Clinical outcomes and health economic evidence that are needed to meet HTA requirements.

This team supports Danaher’s Diagnostic and Life Science platforms. We provide country-specific market access strategies in collaboration with CDx Pharma Partners and relevant health care providers.

For more information about our Pharma Partnerships, please contact us.

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