VERIFICATION OF BIOMARKERS
For global clinical studies, it is important that there is global harmonization between different laboratory locations, enabling patient inclusion regardless of where the laboratory test result is generated. Clinical analyzers 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. This is merely an internal procedure to meet a set of assay specifications in compliance with CAP/CLIA.
VALIDATE VS VERIFY
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. Meeting the needs of our Clients and Regulatory Bodies, the most tested attributes in advanced validation may include, but are not limited to:
- 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 GLP or GLP like Method Development and Method Validation.
As more and more biomarker tests become available on clinical analyzers, the limitations, as well as the strengths of these analytical instruments and tests, should be considered. Clinical analyzers 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 GLP and CLIA in one synergetic approach. Our hybrid system allows us to combine best of two worlds when utilizing 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.
Supported by a strong and experienced Scientific Affairs Committee, biomarker assays are developed and or validated fit-for-purpose to meet the specific requirements of the Clinical Trial Program. As our Clinical Biomarker Services are fully integrated in our Central Laboratory, we offer a seamless transition to a production testing environment as any biomarker assay is evaluated for its feasibility as well.