title: Recommendations for biomarker identification and qualification in clinical proteomics.
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.
authors.affiliation: mischak@mosaiquesdiagnostics.com
authors.forename: Harald
authors.initials: H
authors.lastname: Mischak
authors.forename: Günter
authors.initials: G
authors.lastname: Allmaier
authors.forename: Rolf
authors.initials: R
authors.lastname: Apweiler
authors.forename: Teresa
authors.initials: T
authors.lastname: Attwood
authors.forename: Marc
authors.initials: M
authors.lastname: Baumann
authors.forename: Ariela
authors.initials: A
authors.lastname: Benigni
authors.forename: Samuel E
authors.initials: SE
authors.lastname: Bennett
authors.forename: Rainer
authors.initials: R
authors.lastname: Bischoff
authors.forename: Erik
authors.initials: E
authors.lastname: Bongcam-Rudloff
authors.forename: Giovambattista
authors.initials: G
authors.lastname: Capasso
authors.forename: Joshua J
authors.initials: JJ
authors.lastname: Coon
authors.forename: Patrick
authors.initials: P
authors.lastname: D'Haese
authors.forename: Anna F
authors.initials: AF
authors.lastname: Dominiczak
authors.forename: Mohammed
authors.initials: M
authors.lastname: Dakna
authors.forename: Hassan
authors.initials: H
authors.lastname: Dihazi
authors.forename: Jochen H
authors.initials: JH
authors.lastname: Ehrich
authors.forename: Patricia
authors.initials: P
authors.lastname: Fernandez-Llama
authors.forename: Danilo
authors.initials: D
authors.lastname: Fliser
authors.forename: Jorgen
authors.initials: J
authors.lastname: Frokiaer
authors.forename: Jerome
authors.initials: J
authors.lastname: Garin
authors.forename: Mark
authors.initials: M
authors.lastname: Girolami
authors.forename: William S
authors.initials: WS
authors.lastname: Hancock
authors.forename: Marion
authors.initials: M
authors.lastname: Haubitz
authors.forename: Denis
authors.initials: D
authors.lastname: Hochstrasser
authors.forename: Rury R
authors.initials: RR
authors.lastname: Holman
authors.forename: John P A
authors.initials: JP
authors.lastname: Ioannidis
authors.forename: Joachim
authors.initials: J
authors.lastname: Jankowski
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Julian
authors.forename: Jon B
authors.initials: JB
authors.lastname: Klein
authors.forename: Walter
authors.initials: W
authors.lastname: Kolch
authors.forename: Theo
authors.initials: T
authors.lastname: Luider
authors.forename: Ziad
authors.initials: Z
authors.lastname: Massy
authors.forename: William B
authors.initials: WB
authors.lastname: Mattes
authors.forename: Franck
authors.initials: F
authors.lastname: Molina
authors.forename: Bernard
authors.initials: B
authors.lastname: Monsarrat
authors.forename: Jan
authors.initials: J
authors.lastname: Novak
authors.forename: Karlheinz
authors.initials: K
authors.lastname: Peter
authors.forename: Peter
authors.initials: P
authors.lastname: Rossing
authors.forename: Marta
authors.initials: M
authors.lastname: Sánchez-Carbayo
authors.forename: Joost P
authors.initials: JP
authors.lastname: Schanstra
authors.forename: O John
authors.initials: OJ
authors.lastname: Semmes
authors.forename: Goce
authors.initials: G
authors.lastname: Spasovski
authors.forename: Dan
authors.initials: D
authors.lastname: Theodorescu
authors.forename: Visith
authors.initials: V
authors.lastname: Thongboonkerd
authors.forename: Raymond
authors.initials: R
authors.lastname: Vanholder
authors.forename: Timothy D
authors.initials: TD
authors.lastname: Veenstra
authors.forename: Eva
authors.initials: E
authors.lastname: Weissinger
authors.forename: Tadashi
authors.initials: T
authors.lastname: Yamamoto
authors.forename: Antonia
authors.initials: A
authors.lastname: Vlahou
mesh_terms: D015415:Biomarkers; D006801:Humans; D013058:Mass Spectrometry; D040901:Proteomics
chemical_list: D015415:Biomarkers