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Clarigene: a Pandemic Diagnostic Story

C.E. Credits: P.A.C.E. CE Florida CE
Speaker
  • Chief Development Officer, Yourgene Health
    Biography

      Mike has over 10 years' experience in the molecular diagnostics industry with a track record of delivering high quality products. He oversees Product Development activities at Yourgene Health, ensuring compliance to quality and regulatory standards.



      Prior to joining Yourgene Health, formerly Premaitha Health, he successfully led the product design and development of QIAGEN's companion diagnostic systems from project inception through to FDA approval. This included the design and development of assay reagents, software and utilisation of automated instruments and additional regulatory registrations including CE marking, Canadian and Japanese approvals.



      Mike played a key role in mapping the product development process for a diagnostic assay then utilising this to make improvements to processes and projects. Mike has a PhD from University of Manchester, where he also spent two years as a Post-Doctoral Research Associate, and a BSc (Hons) in Human Genetics from the University of Nottingham.


    Abstract

    Developing an in vitro diagnostic device is often a complex and demanding process. Doing so in the midst of a pandemic and the IVD global supply chain stretched like never before, with project teams formed entirely via remote working and under intense time pressure takes this to another level. Clarigene: A pandemic diagnostic development story takes us through how Yourgene Health entered into the infectious disease space, including the major challenges and how they were overcome. Carefully working through market and customer needs enabled key design decisions to made, ultimately leading to a robust product being released onto the market. The implementation of the Clarigene SARS-CoV-2 test in the company’s service lab, including in house automation and development of wrap around sample tracking software, demonstrated the product to be a robust and scalable test that could be applied quickly and effectively into any laboratory setting. In the face of multiple mutations in the viral genome, enhanced post-market surveillance and risk mitigation planning is key to ensuring any SARS-CoV-2 test can be relied upon to perform as expected as new strains arise.

    Learning Objectives:

    1. Meeting customer needs through effective product design

    2. Handling product development under difficult conditions

    3. Monitoring viral genomes to ensure test performance is not impacted by random mutations


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