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