Biomarker Validation and Qualification

Validation is the process of evaluating the reliability, reproducibility and accuracy of the biomarker across a range of experimental conditions. Qualification process provides an evidentiary link between the biomarker and biological processes/clinical end points.

Following validation and qualification, a biomarker can be used to diagnose the risk, presence and prognosis of a disease in an individual. In evaluating potential drug therapies, a biomarker may be used as a surrogate for a natural endpoint such as survival or irreversible morbidity. If a treatment alters the biomarker, which has a direct connection to improved health, the biomarker serves as a surrogate endpoint for evaluating clinical benefit. Some of the main areas in which molecular biomarkers are used in the drug development process are: early drug development studies, safety studies, proof of concept studies, and molecular profiling.

We offer assay development and validation for prognostic/predictive clinical biomarkers and pathway activation biomarkers:

  • Mutliplex immunoassay
  • Multiplex nucleic acid testing
  • Western Blot
  • Clinical Chemistry assays