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  • 1.  FDA Clinically Qualified Kidney Panel Composite Measure. Is still used and if so who has it?

    Posted 04-18-2024 12:53

    A few years back a panel of 6 biomarkers was qualified by the FDA under CDER; Urinary nephrotoxicity biomarker panel as assessed by immunoassays. PacBio supported this as part of a consortium. The majority of the assays are RUO ELISA kits which were validated under CAPCLIA to support the data package and offered as fee for service by PacBio and later by Nexelis after they acquired PacBio. The COU of use is for cohort level decisions. However today this panel is no longer available after Q2 acquired Nexelis .

    A bioanalytical validation with the addition of normal range would also meet this COU 

    Is this panel still useful? Is there another CRO that offers this panel? 

    DDTBMQ000014 FNIH PSTC Executive summary final (fda.gov)



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    Lindsay King Ph.D.
    Senior Director
    Pfizer Inc

    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 2.  RE: FDA Clinically Qualified Kidney Panel Composite Measure. Is still used and if so who has it?

    Posted 04-23-2024 09:39

    Hi Lindsay,

    Pleasure to reconnect. We do use this panel, most recently with Parexel (although I believe they subcontracted). If you are interested in more information please reach out and I can inquire for more details.

    Cheers,

    Gerard



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    Gerard Honig
    Associate Director, Biomarker Research
    Otsuka Pharmaceuticals
    Glassboro NJ
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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    Original Message


  • 3.  RE: FDA Clinically Qualified Kidney Panel Composite Measure. Is still used and if so who has it?

    Posted 04-23-2024 22:58

    Hi Lindsay,

    The panel is still useful and the subsequent data generated from specific drug trials using the composite measure from the panel is in review by the FDA.  In the US, GenX, a lab based in LA, can be used. LabCorp (former Covance) can be used world-wide. 

    Remember that only the biomarkers, not the assays, are qualified for a specific COU, but the analytical performance characteristics of the two above labs were quite similar and within the specifications we (Kidney Safety Project of C-Path) had set in the qualification package. Pacific Biomarkers of Seattle was the testing lab; PacBio is a long read NGS sequencing concern.

    Regards,

    Steve

    Steven P Piccoli

    Head, Clinical Biomarkers andDiagnostics

    Sun Pharma Advanced Research

    The analytical performance characteristics of the two labs were quite similar and within the specifications we had set in the qualification package.



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    Steven Piccoli
    Head, Clinical Biomarkers
    Sun Pharma Advanced Research
    Princeton NJ
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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    Original Message