CDx Development

Support and guidance at every stage of the process

Your next pathology-based CDx starts here.

With the complexity of therapies increasing, the need for a robust companion diagnostic (CDx) has never been higher. Advances in tissue analysis technologies now require a more quantitative, accurate, and precise pathology-based CDx.

Bringing your CDx to market requires a solid strategy to meet strict regulatory standards and critical timelines.

Your CDx pipeline needs a trusted partner with expertise in novel biomarker and tissue analysis and CDx development.

Support for CDx development

  • Assay technologies:
    • IHC, CISH, FISH, Multiplex
  • Interpretation methods
    • Manual Pathology
    • Image Analysis
  • Regulatory strategy and support
  • Consultation with scientific experts

White Paper

Tissue-Based Pathology Companion Diagnostic Development for Regulated Applications

Your guide to navigating through key points in the CDx development process.

Support for CDx development

Each phase of CDx development has its unique challenges. We are here to guide you through each one.

Consultation & preclinical testing

Consultation on trial planning including timelines and regulatory requirements.
Preclinical target prevalence screening studies in normal and diseased tissues.

Data collection, assay development & validation

Determine tissue endpoints using advanced wet assay and image analysis technologies.
Analytical validation of the CDx prototype for use in clinical trial patient selection.

Patient selection & proof-of-concept submission

Conduct CAP-compliant LDT testing for patient selection.
Collect pathology image analysis data for real-time treatment response monitoring.
Adjust the LDT or endpoints by reanalyzing stored data and without repeating the trial.

Trial expansion & regulatory submission

Select a manufacturing partner for CDx production that can meet regulatory and performance criteria.
Prepare regulatory submission supported by validated CDx performance data.

CDx Deployment

Run your CDx in our Clinical Diagnostics CAP/CLIA lab during the manufacturer optimization period or beyond regulatory approval to support expanded distribution.
If the test proves too challenging for distribution, we will support your CDx as a single-site FDA test in our Clinical Diagnostics Lab.