From biomarker strategy to clinical trial testing

Every biomarker program starts with a different scientific question. Understanding the intended use of the biomarker data helps determine the appropriate approach to assay development, verification and validation.

For commercially available assays on clinical analysers, verification of manufacturer specifications is often sufficient for use in clinical CAP/CLIA laboratories. When biomarker data are used for decision-making or regulatory purposes, however, advanced method validation beyond CAP/CLIA verification may be required.

That distinction is fundamental to our approach.

Verify - “Are you testing it right?”

Verification demonstrates that an assay performs according to established specifications in the laboratory environment.

Validate - “Are you testing the right thing?”

Validation provides a more extensive assessment of assay performance in relation to its intended purpose.

Depending on the intended use, advanced validation may assess technical characteristics such as:

• Selectivity

• Specificity 

• Accuracy

• Precision 

• Reproducibility

• Limit of detection

• Limit of quantification

• Calibration curve

• System suitability

Fit-for-purpose biomarker assay validation: validation designed around the needs of your clinical trial

Biomarker assays are developed and fit-for-purpose validated to meet the specific requirements of the clinical trial program.

For biomarker data used in clinical decision-making and regulatory applications, advanced validation can provide additional characterization beyond routine CAP/CLIA verification.

And importantly, the work does not end with validation.

Because our Biomarker Services are integrated within Eurofins Central Laboratory, assays can transition into a high-volume production testing environment within the Central Laboratory.

The benefit for sponsors: scientific rigor combined with the operational environment required for clinical trial testing

Supporting global clinical trials: consistency across laboratory locations matters

Global trials require biomarker results that can be used confidently across regions. Harmonization and standardization across laboratory locations are therefore critical to the validity of biomarker utilization. 

Our integrated approach connects biomarker assay development and validation with central laboratory testing, creating continuity as an assay moves from scientific development towards broader clinical trial use. 

 
Explore our established biomarker capabilities

• Inflammation & immunology: BAFF, IL-5, IL-13, IL-18, MCP-1, TARC/CCL17

• Renal-related biomarkers: KIM-1, NGAL, Nephrin, Cystatin-C

• Bone-related biomarkers: CTX1, P1NP

• Other validated assays include: Calprotectin, Cortisol, Periostin, NT-proBNP, Testosterone and Tryptophan

Scientific expertise behind every assay: a fit-for-purpose approach to biomarker development

The right analytical approach depends on the biomarker, its intended use and the requirements of the clinical development program.

Supported by an experienced scientific team, Eurofins Central Laboratory develops and fit-for-purpose validates biomarker assays according to the specific requirements of the clinical trial program.

Combining advanced validation with integrated central laboratory testing provides continuity from assay development into the clinical trial testing environment.

Whether you need an established validated assay or support for a specific biomarker requirement, our teams can help define an approach aligned with the intended use of your biomarker data and your clinical trial program.