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Research article2010Peer reviewedOpen access

Recommendations for biomarker identification and qualification in clinical proteomics

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

Published in

Science Translational Medicine
2010, Volume: 2, number: 46, article number: 46ps42

    UKÄ Subject classification

    Cell and Molecular Biology
    Clinical Laboratory Medicine

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