Biomarkers

Biomarker Testing: A Key Tool for Disease Diagnosis and Treatment

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Biomarker analysis enables you to assess a therapeutic’s efficacy, safety, and mechanism of action to make go/no go decisions during the drug development process. Biomarker assays can also validate targets and identify potential toxicity.

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Advance large molecule, small molecule, and ATMP studies using expert biomarker analysis.

Our services include assay development, validation, and sample analysis, and more than 120 off-the-shelf assays. We use the following techniques: 

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Rely on a scientific team with broad experience in biomarker analysis. 

BioAgilytix provides biomarker analysis to support large molecule, small molecule, and Advanced Therapy Medicinal Products (ATMPs). Our experience includes: 

  • Biomarkers in singleplex and multiplex formats for a wide range of disease states.  
  • A diverse range of simple to highly complex assays for both routine and esoteric use, across a wide range of technologies and many matrices, including serum, plasma, and tissue homogenates. 
  • All size study cohorts from low- or medium- to high-volume sample testing requirements. 
  • Regulatory expectations for biomarker analytical validations based on the context of use. 
  • Unmatched experience in developing custom biomarker assays that are robust, precise, and analytically appropriate. We validate biomarkers for everything from exploratory to regulated studies. 

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Optimal platforms for biomarker studies

The platforms used in biomarker analysis vary. For exploratory biomarkers, we generate data to help our customers select appropriate analytes to monitor the key pharmacodynamics or to support mechanism of action of the compound. Confirmatory biomarkers support pivotal determinations of efficacy. BioAgilytix works with our clients to design assays for each of these biomarker types using a “fit for purpose” approach, typically leveraging the following platforms:

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