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  • 1.  Clinical Performance for IVD

    This message was posted by a user wishing to remain anonymous
    Posted 14 days ago
    This message was posted by a user wishing to remain anonymous

    Hello all,

    I would appreciate your help and advice on the following.

    we are working on the clinical evaluation of a new IVD device that has no predicate available on the market. the device as per intended use will be for diagnosis of a rare disease. clinical/ patient samples required to run clinical studies are very hard to provide due the low prevalence of the disease and also the stability of the sample. is there any alternative to patient sample that we can use? is there any guidance explaining such situation that i can look at.

    Kind Regards,
    Asma


  • 2.  RE: Clinical Performance for IVD

    Posted 13 days ago
    Hi Asma,

    Since your disease is rare, your sample size should be low and manageable. For sample stability, you should employ suitable lab technique to enhance this.

    PS: Since your device seems novel and you mentioned that no equivalent devices are available, their data cant be used. Of course you can use similar device clinical data but it depends upon NB to accept it or not depending upon closeness of technology, risk benefit ratio and clinical utility.

    Hope this helps
    Rahul

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    Rahul Pandey
    PhD
    New Delhi
    India
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  • 3.  RE: Clinical Performance for IVD

    This message was posted by a user wishing to remain anonymous
    Posted 13 days ago
    This message was posted by a user wishing to remain anonymous

    Hi Rahul,

    thank you so much for your reply.

    as it is a rare disease it is not easy to get samples for clinical study. can we use simulated samples/ QC panel instead? is there any reference/standard that we can rely on to explain use of such alternative?

    thanks, Asma



  • 4.  RE: Clinical Performance for IVD

    Posted 13 days ago
    Hello Asma,

    The Clinical Laboratory Standards Institute (clsi.org) document EP39: A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests will likely be very helpful for you. It walks through the thought process and options for selecting surrogate samples when validating an IVD. I'm not sure which regulatory agency you interact with, but it is recognized by FDA as a consensus standard as well.

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=42930

    ------------------------------
    Shannon Bennett
    Director of Regulatory Affairs
    Rochester MN
    United States
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  • 5.  RE: Clinical Performance for IVD

    This message was posted by a user wishing to remain anonymous
    Posted 8 days ago
    This message was posted by a user wishing to remain anonymous

    Hi Shannon,

    Thank you very much for your reply.

    This is a very useful standard and has lots of info that I was looking for. I appreciate sharing this!

    Kind Regards, Asam




  • 6.  RE: Clinical Performance for IVD

    This message was posted by a user wishing to remain anonymous
    Posted 8 days ago
    This message was posted by a user wishing to remain anonymous

    Hi Shannon,

    Thank you very much for your help. This is what I was looking for. Very useful CLSI. Really appreciated!


  • 7.  RE: Clinical Performance for IVD

    Posted 6 days ago
    Edited by Ashwin Nair 6 days ago
    Hi Asma,

    As Sharon suggested, do review the CLSI document. I would also suggest that you reach out to your regulatory agency early on. For example, you can request a pre-submission meeting with the US FDA. It will be helpful, in case you are looking at a De Novo classification process. You can also seek clarification on the acceptable surrogate sample, especially because your physiological sample is not very stable.

    Good luck

    Ashwin

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    Ashwin Nair, PhD
    TX, USA
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