Abstract
Although discovering proteomic biomarker by using mass spectrometry technique is promising, its rate of introducing proteomic biomarker approved by the US Food and Drug Administration is falling every year and nearly 1 per year on an average since 1998. Apparently, there is a big gap between biomarker discovery and biomarker validation. Here, we reviewed the challenges appearing in the three key stages for the pipeline of proteomic biomarker, that is, blood sample preparation, bioinformatics algorithms for biomarker candidate discovery, and validation and clinical application of proteomic biomarkers. To analyze and explain the reasons for the gap between biomarker discovery and validation, we covered areas ranging from the techniques/methods used in biomarker discovery and their related biological backgrounds to the existing problems in these techniques/methods.
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