• Open Access

Implementation of proteomic biomarkers: making it work

Authors

  • Harald Mischak,

    1. BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK
    2. Mosaiques diagnostics, Hannover, Germany
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    • The first two authors contributed equally.

    • Member of the European Kidney and Urine Proteomics COST Action (EuroKUP).

    • Member of the European Uremic Toxins (EUTox) Work Group.

  • John P.A. Ioannidis,

    1. Clinical and Molecular Epidemiology Unit, Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece
    2. Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA
    3. Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA, USA
    4. Department of Statistics, Stanford University School of Humanities and Sciences, Stanford, CA, USA
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    • The first two authors contributed equally.

  • Angel Argiles,

    1. RD Néphrologie, Montpellier Cedex, France
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    • Member of the European Uremic Toxins (EUTox) Work Group.

  • Teresa K. Attwood,

    1. Faculty of Life Sciences and School of Computer Science, University of Manchester, Manchester, UK
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    • Member of the European Kidney and Urine Proteomics COST Action (EuroKUP).

  • Erik Bongcam-Rudloff,

    1. Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden
    2. Department of Animal Breeding and Genetics, Swedish University of Agricultural Sciences, Uppsala, Sweden
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    • Member of the European Kidney and Urine Proteomics COST Action (EuroKUP).

  • Mark Broenstrup,

    1. Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Germany
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  • Aristidis Charonis,

    1. Divisions of Histology and Biotechnology, Biomedical Research Foundation, Academy of Athens, Athens, Greece
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    • Member of the European Kidney and Urine Proteomics COST Action (EuroKUP).

  • George P Chrousos,

    1. First Department of Pediatrics, Athens University Medical School, Aghia Sophia Children’s Hospital, Athens, Greece
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  • Christian Delles,

    1. BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK
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  • Anna Dominiczak,

    1. BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK
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    • Member of the European Kidney and Urine Proteomics COST Action (EuroKUP).

  • Tomasz Dylag,

    1. European Commission, Directorate-General for Research and Innovation, Unit F5: Personalised Medicine, 21 rue du Champ de Mars, Brussels, Belgium
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  • Jochen Ehrich,

    1. Hannover Medical School, Department of Pediatrics, Hannover, Germany
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  • Jesus Egido,

    1. IIS-Fundación Jiménez Díaz, Autonoma University, Madrid, Spain
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    • Member of the European Kidney and Urine Proteomics COST Action (EuroKUP).

  • Peter Findeisen,

    1. C Institute of Clinical Chemistry, Universitätsklinikum Mannheim, Mannheim, Germany
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  • Joachim Jankowski,

    1. Charité (CBF), Medizinische Klinik IV, Berlin, Germany
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    • Member of the European Kidney and Urine Proteomics COST Action (EuroKUP).

    • Member of the European Uremic Toxins (EUTox) Work Group.

  • Robert W. Johnson,

    1. Abbott Laboratories, Abbott Park, IL, USA
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  • Bruce A. Julien,

    1. Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA
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  • Tim Lankisch,

    1. Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany
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  • Hing Y. Leung,

    1. The Beatson Institute for Cancer Research, Garscube Estate, Glasgow, UK
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  • David Maahs,

    1. Barbara Davis Center for Childhood Diabetes, University of Colorado Denver, Aurora, CO, USA
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  • Fulvio Magni,

    1. Department of Experimental Medicine, University of Milano-Bicocca, Monza, Italy
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    • Member of the European Kidney and Urine Proteomics COST Action (EuroKUP).

  • Michael P. Manns,

    1. Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany
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  • Efthymios Manolis,

    1. European Medicines Agency, London, UK
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  • Gert Mayer,

    1. Department of Internal Medicine IV, Medical University of Innsbruck, Innsbruck, Austria
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  • Gerjan Navis,

    1. Division of Nephrology, Department of Internal Medicine, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
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  • Jan Novak,

    1. Department of Microbiology, University of Alabama at Birmingham, Birmingham, AL, USA
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  • Alberto Ortiz,

    1. IIS-Fundación Jiménez Díaz, Autonoma University, Madrid, Spain
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    • Member of the European Kidney and Urine Proteomics COST Action (EuroKUP).

    • Member of the European Uremic Toxins (EUTox) Work Group.

  • Frederik Persson,

    1. Steno Diabetes Center, Gentofte, Denmark
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  • Karlheinz Peter,

    1. Baker Heart Research Institute, Melbourne, Victoria, Australia
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    • Member of the European Kidney and Urine Proteomics COST Action (EuroKUP).

  • Hans H. Riese,

    1. European Projects Office, Institute of Health Carlos III, Madrid, Spain
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  • Peter Rossing,

    1. Steno Diabetes Center, Gentofte, Denmark
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    • Member of the European Kidney and Urine Proteomics COST Action (EuroKUP).

  • Naveed Sattar,

    1. BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK
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  • Goce Spasovski,

    1. Department of Nephrology, Medical Faculty, University of Skopje, Skopje, Former Yugoslav Republic of Macedonia
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    • Member of the European Kidney and Urine Proteomics COST Action (EuroKUP).

    • Member of the European Uremic Toxins (EUTox) Work Group.

  • Visith Thongboonkerd,

    1. Faculty of Medicine at Siriraj Hospital, Mahidol University, Bangkok, Thailand
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    • Member of the European Kidney and Urine Proteomics COST Action (EuroKUP).

  • Raymond Vanholder,

    1. Department of Nephrology, Ghent University Hospital, Ghent, Belgium
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    • Member of the European Kidney and Urine Proteomics COST Action (EuroKUP).

    • Member of the European Uremic Toxins (EUTox) Work Group.

  • Joost P. Schanstra,

    1. Institut National de la Santé et de la Recherche Médicale (INSERM), U1048, Institut of Cardiovascular and Metabolic Disease and Université Toulouse III Paul-Sabatier,Toulouse, France
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    • Member of the European Kidney and Urine Proteomics COST Action (EuroKUP).

  • Antonia Vlahou

    1. Division of Biotechnology, Biomedical Research Foundation, Academy of Athens, 11527 Athens, Greece
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    • Member of the European Kidney and Urine Proteomics COST Action (EuroKUP).


Harald Mischak, BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK. Tel.: +44 141 330 6210; fax: +44 141 330 1689; e-mail: Harald.Mischak@glasgow.ac.uk

Abstract

Eur J Clin Invest 2012; 42 (9): 1027–1036

Abstract

While large numbers of proteomic biomarkers have been described, they are generally not implemented in medical practice. We have investigated the reasons for this shortcoming, focusing on hurdles downstream of biomarker verification, and describe major obstacles and possible solutions to ease valid biomarker implementation. Some of the problems lie in suboptimal biomarker discovery and validation, especially lack of validated platforms with well-described performance characteristics to support biomarker qualification. These issues have been acknowledged and are being addressed, raising the hope that valid biomarkers may start accumulating in the foreseeable future. However, successful biomarker discovery and qualification alone does not suffice for successful implementation. Additional challenges include, among others, limited access to appropriate specimens and insufficient funding, the need to validate new biomarker utility in interventional trials, and large communication gaps between the parties involved in implementation. To address this problem, we propose an implementation roadmap. The implementation effort needs to involve a wide variety of stakeholders (clinicians, statisticians, health economists, and representatives of patient groups, health insurance, pharmaceutical companies, biobanks, and regulatory agencies). Knowledgeable panels with adequate representation of all these stakeholders may facilitate biomarker evaluation and guide implementation for the specific context of use. This approach may avoid unwarranted delays or failure to implement potentially useful biomarkers, and may expedite meaningful contributions of the biomarker community to healthcare.

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