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Biomarkers

At ICON's bioanalytical laboratories we understand the context of use principles for biomarker assays.

All biomarker assays are different and require careful consideration to ensure the assays are fit for their intended purpose. We offer different levels of biomarker assay characterisation based on your needs.

ICON’s bioanalytical laboratories are actively following the discussions in the drug development community on CoU for biomarker assays to add value to our sponsor’s drug development programs. Acceptance criteria and the design of the validation studies are always discussed. We do not want to waste resources by generating unusable data and we truly believe that structured scientific evaluations upfront will pay off. We have a system in place to support bioanalytical project managers and scientists to determine the CoU for a biomarker and to define the assay characterisation experiments and acceptance criteria that are needed to show that an assay supports that CoU. 

During sample analysis we actively monitor assay performance with relevant matrix samples to observe assay issues early. This approach helps our sponsors to obtain biomarker data they can rely on.

We have experience in running biomarker assays for various purposes on all our analytical platforms. This ranges from implementing a commercial ELISA kit, to a sensitive Ella assay, or a more complex kit implementation on the ultra-sensitive SMCxPro platform.

Biomarker assays on LC-MS/MS are also routinely developed. Our flow cytometry experts run mostly cell surface biomarkers.
 

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