Recommendations for biomarker identification and qualification in clinical proteomics

Harald Mischak, Günter Allmaier, Rolf Apweiler, Teresa Attwood, Marc Baumann, Ariela Benigni, Samuel E. Bennett, Rainer Bischoff, Erik Bongcam-Rudloff, Giovambattista Capasso, Joshua J. Coon, Patrick D'Haese, Anna F. Dominiczak, Mohammed Dakna, Hassan Dihazi, Jochen H. Ehrich, Patricia Fernandez-Llama, Danilo Fliser, Jorgen Frokiaer, Jerome GarinMark Girolami, William S. Hancock, Marion Haubitz, Denis Hochstrasser, Rury R. Holman, John P A Ioannidis, Joachim Jankowski, Bruce A. Julian, Jon B. Klein, Walter Kolch, Theo Luider, Ziad Massy, William B. Mattes, Franck Molina, Bernard Monsarrat, Jan Novak, Karlheinz Peter, Peter Rossing, Marta Sánchez-Carbayo, Joost P. Schanstra, O. John Semmes, Goce Spasovski, Dan Theodorescu, Visith Thongboonkerd, Raymond Vanholder, Timothy D. Veenstra, Eva Weissinger, Tadashi Yamamoto, Antonia Vlahou

Research output: Contribution to journalArticle

Abstract

Clinical proteomics has yielded some early positive results - the identification of potential disease biomarkers - indicating the promise for this analytical approach to improve the current state of the art in clinical practice. However, the inability to verify some candidate molecules in subsequent studies has led to skepticism among many clinicians and regulatory bodies, and it has become evident that commonly encountered shortcomings in fundamental aspects of experimental design mainly during biomarker discovery must be addressed in order to provide robust data. In this Perspective, we assert that successful studies generally use suitable statistical approaches for biomarker definition and confirm results in independent test sets; in addition, we describe a brief set of practical and feasible recommendations that we have developed for investigators to properly identify and qualify proteomic biomarkers, which could also be used as reporting requirements. Such recommendations should help put proteomic biomarker discovery on the solid ground needed for turning the old promise into a new reality.

Original languageEnglish
Article number46ps42
JournalScience Translational Medicine
Volume2
Issue number46
DOIs
Publication statusPublished - Aug 25 2010

ASJC Scopus subject areas

  • Medicine(all)

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    Mischak, H., Allmaier, G., Apweiler, R., Attwood, T., Baumann, M., Benigni, A., Bennett, S. E., Bischoff, R., Bongcam-Rudloff, E., Capasso, G., Coon, J. J., D'Haese, P., Dominiczak, A. F., Dakna, M., Dihazi, H., Ehrich, J. H., Fernandez-Llama, P., Fliser, D., Frokiaer, J., ... Vlahou, A. (2010). Recommendations for biomarker identification and qualification in clinical proteomics. Science Translational Medicine, 2(46), [46ps42]. https://doi.org/10.1126/scitranslmed.3001249