Fit-for-purpose biomarker assay validation

Verification can be expressed as “are you testing it right?” whereas validation can be expressed as “are you testing the right thing?

Deploying pivotal biomarker data as surrogate endpoints in clinical studies require advanced method validation augmenting CAP/CLIA verification. To meet the needs of our clients and regulatory bodies, the most tested attributes in advanced validation may include, but are not limited to:

Selectivity
Specificity
Accuracy
Precision
Reproducibility
Limit of detection
Limit of quantification
Calibration curve
System suitability

The applied rigor of data documentation, record keeping and reporting, may need to be similar to that of methods for pharmacokinetic support and require GCLP or GLP like method development and method validation.

As more and more biomarker tests become available on clinical analysers, the limitations, as well as the strengths of these analytical instruments and tests, should be considered. Clinical analysers are in most cases highly automated and closed systems (“black boxes”) with limited possibilities to modify or optimize the assays.

Eurofins Central Laboratory is uniquely positioned to validate clinical biomarker assay kits with its biomarker services by uniting GCLP and CLIA in one synergetic approach. Our hybrid system allows us to combine best of two worlds when utilising laboratory biomarkers to prove safety and efficacy, support go/no-go decisions, stratify patients and to support the submission of data sets to regulatory agencies worldwide.

For global clinical studies, it is important that there is global harmonisation between different laboratory locations, enabling patient inclusion regardless of where the laboratory test result is generated.

Clinical analysers and their associated testing kits find great utility in conducting such tests, for which method verification of manufacturer specifications is often sufficient for the use in clinical [CAP/CLIA] laboratories.

Verification of biomarker assays is intended to reproduce commercially available assays. The purpose of verification is to meet a set of assay specifications in compliance with CAP/CLIA.

Our network of CAP-accredited clinical laboratories includes advanced analytical validation strategies for laboratory testing. This integration not only facilitates the generation of safety data but also ensures the production of regulatory-compliant efficacy data on biomarkers. As a result, we provide an environment conducive to rational decision-making in drug development for our clients.

Supported by a strong and experienced Scientific Affairs group, biomarker assays are developed and or validated fit-for-purpose to meet the specific requirements of clinical trial programmes. As our biomarker services are fully integrated in our central laboratory, we offer a seamless transition to a production testing environment as any biomarker assay is also evaluated for its feasibility. The combination of highest standards of quality and logistics, cutting edge technology and a tailored approach makes our biomarker services unique and extremely powerful.

For CE-marked assays under IVDR, Eurofins Central Laboratory monitors the appropriate transition for IVD tests under IVD Directive for compliance with recent IVD Requirements. For most laboratory tests intended for clinical evaluation purposes, diagnostic vendors are transitioning their tests during an approved grace period.