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Companion Diagnostic Development

Companion Diagnostics are a critical part of targeted cancer therapy. For the patient it helps provide better treatment outcomes and lower unnecessary morbidity. For the drug developer it improves the efficiency of clinical trials and helps shorten approval times.

Companion Diagnostic (CDx) development is a core part of the Leica Biosystems' strategy and we have established a dedicated, multi-disciplinary team to enable us to be a comprehensive, full-service partner for Pharma & Biotech developing targeted therapies. We work with our partners to bring CDx assays to market as IVD solutions and have significant experience transferring assays and protocols from a research or LDT setting and converting them into a robust IVD product that can be used globally in a routine hospital setting.

We are dedicated to delivering high quality IVD solutions (instrument, reagent & software) to our customers when they need them. To achieve this, we develop products under strict design control, manufacture under GMP and deliver to our customers via our global sales & support network.


How we make a difference

  • Dedicated Pharma Partnerships Team
    Based in Danvers, MA we have established a dedicated team to ensure full commitment to our Partners programs.  Experienced alliance and project managers provide continuity as the projects move from research through clinical & commercial phases.
  • Comprehensive Automated Histology Solutions
    Our products and expertise span the entire tissue Dx workflow giving us an advantage in developing reproducible & accurate CDx tests. We are uniquely able to provide CDx solutions that combine sample collection, assay automation and image analysis to create a robust, reliable test.
  • Wide Range of Assay Technologies
    We have core in-house expertise in developing IHC, FISH & CISH CDx assays. We can help our partners develop assay reagents or utilise our Partners assay reagents to develop IVD solutions
  • Committed to Partnership
    In order to ensure our partnerships get the focus they deserve, we limit the number of CDx programs we undertake. We strategically evaluate opportunities to ensure that they fit with the core focus of Leica Biosystems in order to ensure a win win scenario for both parties. In everything that we undertake we have an unwavering commitment to Healthcare Compliance.

For more information about our Pharma Partnerships, please contact us. Pharmapartnerships@leicabiosystems.com