Biomarker Testing

Biomarker assays can serve as surrogates for assessing the activity of candidate therapeutics, and are indispensable tools for validating targets, supporting the mechanism of action, predicting therapeutic efficacy, and alerting for potential toxicity. However, the process of identifying and validating new disease-related and pharmacodynamic biomarkers is quite challenging.

Biomarker identification is a multistep and iterative process beginning early in the drug discovery stage that helps build a strong biomarker testing strategy across all phases of development.

Scientist in a lab coat looking through a microscope.

Cell and Gene Therapy Services and Products

Our comprehensive portfolio of preclinical CRO services provides the cell and gene therapy services and products, scientific, and regulatory experts to fully support your integrated program from start to finish.
How Can We Help

Our comprehensive global portfolio of biomarker services covers safety assessment as well as a wide range of therapeutic areas. This can help translate across a wide range of therapeutic areas. We can help translate them to the clinic and beyond while greatly accelerating candidate development and decreasing timelines. Optimal biomarker assays create a knowledge framework for confident decision making to help minimize risk. With techniques like genomics, transcriptomics, proteomics, flow cytometry, and metabolomics, companies may use many different approaches to discover and develop biomarkers.


Biomarker Testing timeline

Our knowledge and expertise allows us to assist with the discovery of biologically and scientifically relevant biomarkers, while measuring and interpreting their changes within the test system, relating them to the drug development program. Scientific excellence is ensured by a synergy between experts in multiple areas, adding value to the studies. From assay qualification to full validation, our experts propose fit-for-purpose validation fully adapted to the context of use (COU) of your biomarkers.

Now CLIA Certified

The addition of the Clinical Laboratory Improvement Amendments (CLIA) certification provides even more versatility to support your diagnostic needs in drug development and helps make informed decisions faster from lead optimization to commercialization. “We are excited to supply these services that are so much in demand and to be able to provide end-to-end diagnostic assay services to our clients for all phases of drug development, including post market.” said Rob Stachlewitz, CVP of Global Lab Sciences.
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Biomarker Platforms and Therapeutic Areas

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Frequently Asked Questions (FAQs) for Biomarker Services