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Kennon Daniels, PhD

Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms.

• Read: Case Study: Rapid Execution of Assay Validation Rescued Global Study

  Translational Research - Assays

  Case Study: Rapid Execution of Assay Validation Rescued Global Study

  Aug 20, ‘26 | 7 min read

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  • Christie B.

    Kennon D.

  Discover
• Read: Case Study: Advancing IHC Assays from RUO to Clinical Trials and CDx

  Assays - Oncology

  Case Study: Advancing IHC Assays from RUO to Clinical Trials and CDx

  May 07, ‘26 | 8 min read

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  • Kennon D.

    Angelique H.

  Discover
• Read: Optimizing Immunohistochemistry Validation and Regulatory Strategies

  Translational Research - Regulatory - Biomarkers - Assays

  Optimizing Immunohistochemistry Validation and Regulatory Strategies

  Nov 15, ‘24 | 8 min read

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  • Kennon D.

    Christie B.

  Discover
• Read: Companion Diagnostics: Key Considerations for Registrational Studies and Effective Co-Development with Therapeutics

  Translational Research - Regulatory

  Companion Diagnostics: Key Considerations for Registrational Studies and Effective Co-Development with Therapeutics

  Apr 17, ‘24 | 4 min read

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  • Kennon D.

    Margaret C.

  Discover
• Read: Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies

  Translational Research - Regulatory - Gene Therapies

  Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies

  Feb 12, ‘24 | 5 min read

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  • Kennon D.

    Margaret C.

  Discover
• Read: 8 Best Practices for Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy

  Translational Research - Regulatory - Gene Therapies

  8 Best Practices for Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy

  Feb 05, ‘24 | 6 min read

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  • Deborah P.

    Kennon D.

    Travis H.

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• Read: Going Beyond Viral Detection: COVID-19 Diagnostics

  Biospecimens

  Going Beyond Viral Detection: COVID-19 Diagnostics

  Feb 17, ‘21 | 3 min read

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    Kennon Daniels, PhD

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• Read: Choosing the Right Partner: Special Sample Needs For In Vitro Diagnostics

  Translational Research

  Choosing the Right Partner: Special Sample Needs For In Vitro Diagnostics

  Feb 04, ‘21 | 2 min read

  • 

    Kennon Daniels, PhD

  Discover

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