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Companion Diagnostic (CDx) Development
At CD BioSciences, our Companion Diagnostic (CDx) Development services bridge targeted biopharmaceutical therapies with precision diagnostics. We partner with pharmaceutical sponsors to codevelop custom CDx assays that identify patients most likely to benefit from specific targeted treatments, monitor therapeutic response, guide dosage adjustments, and inform treatment continuation or discontinuation decisions.
By aligning diagnostic development with therapeutic clinical timelines, our end-to-end CDx platform significantly enhances clinical trial success rates, improves patient safety profiles, and accelerates global regulatory approval—delivering true precision medicine to the market.
Core Services
From Feasibility to PMA SubmissionCDx Strategy & Feasibility Assessment
Strategic roadmap generation aligning diagnostic timelines with therapeutic drug development.
Biomarker Identification & Discovery
Translational biomarker discovery to establish predictive patient enrichment signatures.
Assay Development, Optimization & Analytical Validation
Rigorous assay engineering meeting stringent IVD analytical performance requirements.
Clinical Validation & Regulatory Submission
Pivotal trial execution and full regulatory dossier preparation for global approval.
Integrated CDx Co-Development Pipeline
Seamless alignment with Phase I–III drug development milestones
Feasibility
Biomarker selection & platform strategy formulation.
CTA Development
Prototype optimization & Clinical Trial Assay locking.
Analytical Validation
Pre-clinical validation under strict Quality System Specs.
Clinical Validation
Pivotal Phase III enrollment screening & testing.
Regulatory Approval
PMA/IVD dossier submission & commercial launch.
Co-Develop Your Companion Diagnostic with CD BioSciences
Accelerate your drug development pipeline and maximize clinical trial success. Talk to our CDx regulatory and scientific experts today.