Companion diagnostics connect targeted therapies with the patients most likely to benefit from them. A companion diagnostic provides information that is essential for the safe and effective use of a corresponding therapeutic product, such as identifying eligible patients, detecting clinically relevant biomarkers, or helping reduce treatment-related risk.
Creative Enzymes Diagnostic provides integrated technical support for companion diagnostic development, from biomarker assay feasibility and critical reagent optimization to prototype development, assay transfer, manufacturing assessment, and technical documentation. Our platform combines diagnostic enzyme expertise with assay development capabilities to help pharmaceutical, biotechnology, and diagnostic companies translate biomarker strategies into practical, reproducible testing solutions.
Programs can be tailored to molecular diagnostics, immunoassays, biochemical assays, and other biomarker detection formats using technologies such as PCR, digital PCR, NGS, immunohistochemistry, and FISH.
Successful CDx development requires more than selecting a biomarker and building a detection assay. The therapeutic indication, intended-use population, biological sample, analytical method, clinical development strategy, manufacturing process, and regulatory pathway must be considered together.
Early technical decisions can affect later assay performance and transferability. Biomarker instability, insufficient analytical sensitivity, variable sample quality, reagent inconsistency, or poor manufacturing robustness may delay development if these risks are identified too late.
Our integrated approach helps align:
Our six specialized services support key stages of the CDx development lifecycle.
Custom engineering and optimization of diagnostic enzymes to improve activity, specificity, stability, matrix tolerance, background control, and manufacturing consistency in enzyme-dependent CDx workflows.
Integrated Drug-CDx Co-Development
Coordinated development support aligning therapeutic milestones, biomarker strategy, assay development, sample planning, analytical studies, and technical documentation.
End-to-End CDx Technology Platform
An integrated platform connecting assay design, critical reagent development, analytical optimization, prototype verification, technology transfer, and documentation support.
Biomarker Assay Feasibility and Prototype Development
Early-stage evaluation of biomarker detectability, sample compatibility, assay format, critical reagents, preliminary analytical performance, and prototype feasibility.
CDx Assay Transfer and Manufacturability Assessment
Evaluation of method transferability, reagent scalability, process robustness, lot consistency, workflow suitability, and manufacturing risks.
CDx Technical Documentation and Regulatory Support
Preparation and organization of assay methods, analytical reports, reagent specifications, development records, risk-related materials, and technical content supporting regulatory activities.
Our typical development workflow includes six stages:
Compile agreed development records, analytical reports, specifications, transfer materials, and regulatory-supporting technical content.
Companion diagnostic and biomarker assay programs can support patient stratification, treatment selection, or therapeutic risk assessment across several fields.
Enzyme and Assay Expertise
Our diagnostic enzyme capabilities provide a strong technical foundation for developing sensitive and reproducible enzyme-dependent CDx assays.
Integrated Development Support
Biomarker feasibility, assay development, reagent optimization, transfer, and documentation can be coordinated within one technical program.
Fit-for-Purpose Strategies
Projects are designed around the intended use, specimen type, assay platform, development phase, and sponsor-defined requirements.
Early Risk Identification
Feasibility and manufacturability assessments help identify technical, reagent, stability, and transfer risks before later-stage investment.
Flexible Collaboration Models
We can support a complete development workstream or address a specific technical challenge within an existing sponsor-led CDx program.
| Service | Development Focus |
|---|---|
| Enzyme Engineering for CDx | Optimization of enzyme activity, specificity, stability, matrix tolerance, background control, and reagent consistency. |
| Integrated Drug-CDx Co-Development | Alignment of therapeutic, biomarker, sample, assay, and technical development milestones. |
| End-to-End CDx Technology Platform | Integrated assay design, reagent development, analytical optimization, transfer, and documentation support. |
| Biomarker Assay Feasibility and Prototype Development | Evaluation of biomarker detectability, sample compatibility, platform suitability, and prototype performance. |
| CDx Assay Transfer and Manufacturability Assessment | Assessment of transferability, process robustness, scalability, reagent consistency, and manufacturing readiness. |
| CDx Technical Documentation and Regulatory Support | Preparation and organization of development reports, analytical records, specifications, transfer materials, and regulatory-supporting content. |
Q1. What information is needed to begin a CDx project?
Q2. Can a project begin before the final assay platform is selected?
Q3. Can you support only one stage of an existing CDx program?
Q4. Do you provide regulatory approval services?
Q5. Can you help transfer an assay developed by another laboratory?
