Companion and Complementary Diagnostics

Companion and Complementary Diagnostics

From Biomarker Discovery to Clinical Implementation

1st Edition - May 8, 2019

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  • Editor: Jan Trøst Jørgensen
  • eBook ISBN: 9780128135402
  • Paperback ISBN: 9780128135396

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Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies.

Key Features

  • Covers all aspects, from biomarker discovery, to development and regulatory approval
  • Explains the "how to" aspects of companion diagnostics
  • Incorporates information on the entire process, allowing for easier and deeper understanding of the topic


Scientists and health care professionals working in academic research institutions, hospitals as well as pharma, biotech and diagnostic companies. Academics such as molecular biologists, human biologists, clinical chemists, bio-engineers, biostatisticians/bioinformatics, pharmacists, pathologists, and clinicians

Table of Contents

  • 1. Foreword
    2. An Introduction to Companion and Complementary Diagnostics
    3. The Drug-Diagnostic Co-Development Model
    4. Systems Biology and Biomarker Development in Cancer Signaling Therapy
    5. Immunohistochemistry
    6. In Situ Hybridization
    7. Polymerase Chain Reaction
    8. Next Gen Sequencing Based Companion Diagnostics: From Biomarker Discovery to Clinical Implementation
    9. Current Next Generation Sequencing Based Companion Diagnostics and their Analytical Validation
    10. Companion and Complementary Diagnostics by Mass Spectrometry
    11. Molecular Imaging Companion Diagnostics
    12. Circulating Tumor DNA Analysis and Opportunities for Personalized Cancer Medicine
    13. Companion Diagnostics Assay Development – Prototype, Verification and Analytical Validation
    14. Tissue is the Issue: Challenges in Oncology Clinical Trial Tissue Sample Collection for Biomarker Analyses and Companion Diagnostics
    15. Adaptive Trial Designs for Biomarker Driven Clinical Trials with Quantitative and Multiple Candidate Biomarkers
    16. Companion Diagnostics Based on Time to Event Data
    17. Regulatory Requirements for Companion Diagnostics and Drug-Diagnostic Co-Development in the United States of America
    18. Companion Diagnostics and Biomarker Tests in the European Medicines Agency’s Assessment of Medicinal Products
    19. Understanding the Current Regulatory Landscape for Companion Diagnostic Products in China
    20. Regulatory requirements for companion diagnostics – Japan
    21. Economic Evaluation of Companion and Complementary Diagnostics
    22. A Risk Based Paradigm of Biomarkers in Clinical Trials
    23. Implementing Companion Diagnostic Testing in the Clinic
    24. Osimertinib (TAGRISSO) and the cobas EGFR Mutation Test v2
    25. QMS Omecamtiv Mecarbil Immunoassay and Omecamtiv Mecarbil Co-Development
    26. Current Status and Future Direction of Companion Diagnostics

Product details

  • No. of pages: 508
  • Language: English
  • Copyright: © Academic Press 2019
  • Published: May 8, 2019
  • Imprint: Academic Press
  • eBook ISBN: 9780128135402
  • Paperback ISBN: 9780128135396

About the Editor

Jan Trøst Jørgensen

Jan Trøst Jørgensen holds a master’s degree in pharmaceutical science and a Ph.D. in clinical pharmacy from the University of Copenhagen, Denmark. He has more than 30 years of experience in research and development in pharmaceutical, biotech and diagnostic companies, such as Novartis, Novo Nordisk and Dako/Agilent. Within the past 15-20 years, his focus has been on drug-diagnostic co-development projects in oncology. Dr. Jørgensen is a strong supporter of a more individualized pharmacotherapy, and he has published a number of scientific papers on companion diagnostics, drug-diagnostic co-development as well as on stratified and personalized medicine. Furthermore, he has been quoted as inventor or co-inventor on several patents and patent applications. He also serves as referee for scientific journals and research foundations and he has given lectures at various universities as well as at national and international conferences. In the recent years, Dr. Jørgensen has also worked as editor and co-author on books and special focus editions for scientific journals and are member of several editorial boards. Dr. Jørgensen was featured in 2015 interview for Elsevier R&D Solutions, Pharm & Life Sciences about his work on precision medicine and his development of a drug-diagnostic co-development model.

Affiliations and Expertise

Director, Dx-Rx Institute, Denmark

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