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  • 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 Yourgene Genomic Services 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

  • LDT Development Workflow +

    Laboratory Developed Test (LDT) Process

    • Assay requirements. Our team of assay development scientists will work with you to discuss your requirements for the test to determine the best approach to use, e.g. platform, sample type etc
    • Assay development can then be carried out using our wide range of technology platforms, your Project Manager will keep you informed every step of the way
    • Validation – assays can be validated according to e.g. CLSI guidelines or a custom validation protocol can be agreed
    • Clinical processing. Once validation is complete your clinical samples can be processed according to a number of different regulatory requirements

  • LDT Menu +

    • Our in house Laboratory Developed Test (LDT) menu contains pre-validated assays ready to use in your study
    • Assays can be run on any third party platform
    • Please contact us to discuss your requirements

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