AUG 07, 2018 08:00 AM PDT

Using Reference Standards to Validate your NGS Oncology Workflow

SPONSORED BY: Horizon Discovery
C.E. CREDITS: P.A.C.E. CE | Florida CE
  • Diagnostics Product Manager, Horizon Discovery
      Hannah joined Horizon as a Product Development Manager in 2016 working with the scientific R&D team to develop new reference standards, before transitioning to the Commercial team as the Diagnostics Product Manager in 2017. Prior to joining Horizon, Hannah was Project Manager for the Stratified Medicine Scotland Innovation Centre (SMS-IC) in Glasgow, where she supported the establishment of a new 8-sequecencer Ion Proton NGS lab and data centre in collaboration with Thermo Fisher Scientific. After completing her PhD in Molecular Cell Biology at Glasgow University, Hannah worked as an Analyst and then Study Manager at BioOutsource - a Scottish CRO specialising in immunotherapy screening assays for Biosimilar antibody efficiency testing. Hannah holds a PRINCE2 Practitioner Certificate in Project Management, and obtained her BSc (Hons) degree in Molecular Biology from Edinburgh University.


    DATE: August 7, 2018
    TIME: 08:00AM PDT, 11:00AM EDT

    We are currently at an exciting precipice in clinical oncology management, where an increased rate of biomarker identification is driving the development of new targeted therapies, coupled with advances in sequencing technology capability.

    In the latest version release of COSMIC (v85) there are now 719 cancer-associated genes listed in the Cancer Gene Census, and in 2017 35% of the new molecular entities (NMEs) approved by the FDA were precision medicines. As a result, we are seeing larger and more complex gene panels being designed by assay developers to support the clinical community in testing for actionable mutations in these genes. This now includes more challenging variant types such as CNVs, INDELs and gene fusions. 

    Any new NGS assays coming to market need to be properly validated before they can be used for patient testing, as errors can occur in sample handling, library prep, sequencing and bioinformatics analysis – which can lead to inaccurate test results. Horizon offers a wide range of reference standards to support the validation of NGS sequencing assays, from development to routine quality monitoring.

    In this webinar, we will discuss the requirements for assay validation, how to select the correct reference standard, frequent challenges, and best practices.

    Learning Objectives:

    • Learn the main criteria to check when introducing a new assay to your lab's testing menu
    • Recognize how to select the most appropriate reference standard for your assay
    • Learn the best practices for initial assay validation and routine quality monitoring

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