Intertek has validated a select number of assays for biomarkers used in GLP-compliant preclinical and clinical development programs.
Assays for biomarkers can be very useful in the selection of a lead compound, determining the mechanism of action of a drug, as a surrogate marker for monitoring clinical efficacy, or for identifying intermediate endpoints of success to decrease follow-up time for a specific treatment. The potential for a specific biomarker assay in a blood sample to give an early indication of drug efficacy can assist both with reducing attrition rates and optimizing clinical development programs.
Intertek has a dedicated team with expertise in the qualification and validation of biomarkers using ELISA and Electrochemiluminescence (ECL) platforms in multiple matrices and anticoagulants. Industry-leading scientific expertise also includes developing and validating prototypes from MesoScale Discovery (MSD)™ custom multiplex technology.