Companion Diagnostic Development - CD BioSciences

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Companion Diagnostic Development

Companion Diagnostic (CDx) Development

Companion Diagnostic 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 Submission
01

CDx Strategy & Feasibility Assessment

Strategic roadmap generation aligning diagnostic timelines with therapeutic drug development.

Target & Technology Selection: Evaluating platform suitability (IHC, NGS, PCR, FISH) for target biomarkers.
Regulatory Pathway Mapping: Strategy consulting for global co-development (FDA PMA/510(k), CE-IVDR).
02

Biomarker Identification & Discovery

Translational biomarker discovery to establish predictive patient enrichment signatures.

Predictive Biomarker Discovery: Multi-omics profiling to pinpoint predictive response signatures.
Clinical Threshold Definition: Establishing cutoff scoring frameworks (e.g., TPS, CPS, H-Score).
03

Assay Development, Optimization & Analytical Validation

Rigorous assay engineering meeting stringent IVD analytical performance requirements.

Assay Optimization: Reagent formulation, control selection, and automated protocol locking.
Analytical Validation: Assessing precision, sensitivity (LoD), specificity, cross-reactivity, and stability.
04

Clinical Validation & Regulatory Submission

Pivotal trial execution and full regulatory dossier preparation for global approval.

Clinical Validation Support: Trial site testing, CTA (Clinical Trial Assay) transfer, and concordance testing.
Regulatory Submissions: Complete support for FDA PMA, IDE, 510(k), and international CE-IVDR filings.

Integrated CDx Co-Development Pipeline

Seamless alignment with Phase I–III drug development milestones

1

Feasibility

Biomarker selection & platform strategy formulation.

2

CTA Development

Prototype optimization & Clinical Trial Assay locking.

3

Analytical Validation

Pre-clinical validation under strict Quality System Specs.

4

Clinical Validation

Pivotal Phase III enrollment screening & testing.

5

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.