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  • 1.  NGS Performance Characteristics/Evidence of Clinical Performance Under IVDR

    Posted 15-Nov-2023 16:10

    Hi all, 

    I am curious if anyone has insight into NB expectations for both Performance Characteristics and evidence within PERs, etc, for assays which gather information on a large swath of markers for, say, tumor characterization. 

    With the understanding that all of this needs to go back to supporting intended use, and scientific validity will provide the basis for which specific variants are directly correlated with specific diseases, what level of detail is expected here?

    Is it sufficient to give an overarching statement of, for example, PPV> 96% for all of mutation type X. It seems way too onerous for all involved to provide data on potentially thousands of variants, though I would also assume more information would be expected anywhere, say, a professional guideline states a large degree of evidence for clinical significance?

    Thanks in advance for any insight.



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    Jason Retzlaff
    Regulatory/QS Specialist
    Saint Paul MN
    United States
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  • 2.  RE: NGS Performance Characteristics/Evidence of Clinical Performance Under IVDR

    Posted 16-Nov-2023 01:51

    Hi Jason,

    This is a question I ask almost every week in different avenues.  I get many a blank stare, shrug of shoulders, or long-winded answers with no answer.  Thus, I deduce currently that no one really knows how to handle this from a performance evaluation perspective.  Indeed it would be significantly onerous to provide all of the data, but the EU MDR and EU IVDR are getting know synonymously with onerous and burdensome.  Plus this is all new to everyone, including the regulators, without any clear direction or guidance at this time for NSG tests and many of the previously "in-house" managed tests.  It will be interesting how all of this unfolds in the next few years.  Like you I am curious and would love to hear a clear direction from anyone on this topic.  (Of course, I have my thoughts and ideas, but again they largely fall on the blank stares and shrugs.)



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: NGS Performance Characteristics/Evidence of Clinical Performance Under IVDR

    Posted 23-Nov-2023 03:29

    Hi Jason, 

    First of all best of luck with the conformity assessment of your device and you have identified the key (or at least one of the key area's where it will need some thought and planning)

    I will say a few things.

    Everything will come back to your intended purpose. How you define and layout your intended purpose locks in everything (at least initially and make it gets some tweaks along the way)

    If you have a NB, request a structured dialogue. 

    If you do not have a NB, (and I really can't stress this enough) consider how soon you need your CE mark, current timeline are decent for IVDR NB's and all have capacity for new applications (maybe not for all types of devices). 2024 will see these spaces filled very quickly.

    And to end on some good news I believe there was a similar NGS device CE marked earlier this year, so it is possible.



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    Tom Patten,
    NSAI,
    Ireland.
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    Original Message


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