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Model CDX - Pathology-Based Companion Diagnostic (CDx) Development Software
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.
- Assay technologies:
- IHC, CISH, FISH, Multiplex
- Interpretation methods
- Manual Pathology
- Image Analysis
- Regulatory strategy and support
- Consultation with scientific experts
1. Pre-IND
Consultation & preclinical testing
Consultation on trial planning including timelines and regulatory requirements.
Preclinical target prevalence screening studies in normal and diseased tissues.
2. Phase 1
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.
3. Phase II
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.
4. Phase III
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.
5. Phase IV/Commercialization
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.