Assay Development and Validation

Assay development

The development of an assay for use in a clinical trial is a three stage process underpinned by an initial assay development stage to ensure that the assay is fit for transition into a clinical setting. The Ex5 Genomics Team has significant experience in the development and evaluation of assays for use in GCP studies. This development and evaluation process will allow your assay to proceed through analytical validation with the confidence that your assay is future proofed for clinical use.

  • Custom assay development is available on a wide range of platforms:
    • Invader
    • TMA
    • Microarrays
    • qPCR
    • Invader
    • Sequencing/fragment analysis
    • Luminex
  • Applications include:
    • Gene expression
    • Genotyping
    • InDels
    • miRNA
    • Methylation

Assay validation

Analytical validation represents the next step within the drug development process and is required to demonstrate the fitness/robustness of an assay, such that the same result will be reproduced using different operators, reagents, labs and equipment. The requirements for these studies are largely driven by the technology being employed as well as the associated guidelines and the intended use of the assay.

  • Identification of control samples
  • Generation of assay specific SOPs
  • Production of validation plan
  • Execute validation study, e.g.
    • Repeatability
    • Reproducibility
    • Accuracy
    • LOD, LOQ, LOB
    • Linearity
    • Reportable range
  • Production and approval of validation report
  • Assay ready for clinical use

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