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2015 ; 4
(3
): 256-269
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Cancer biomarker discovery and validation
#MMPMID26213686
Goossens N
; Nakagawa S
; Sun X
; Hoshida Y
Transl Cancer Res
2015[Jun]; 4
(3
): 256-269
PMID26213686
show ga
With the emergence of genomic profiling technologies and selective molecular
targeted therapies, biomarkers play an increasingly important role in the
clinical management of cancer patients. Single gene/protein or multi-gene
"signature"-based assays have been introduced to measure specific molecular
pathway deregulations that guide therapeutic decision-making as predictive
biomarkers. Genome-based prognostic biomarkers are also available for several
cancer types for potential incorporation into clinical prognostic staging systems
or practice guidelines. However, there is still a large gap between initial
biomarker discovery studies and their clinical translation due to the challenges
in the process of cancer biomarker development. In this review we summarize the
steps of biomarker development, highlight key issues in successful validation and
implementation, and overview representative examples in the oncology field. We
also discuss regulatory issues and future perspectives in the era of big data
analysis and precision medicine.