Background: Proteomics has evolved into a large-scale biomarker discovery program; however, these initiatives are viewed as failing owing to a lack of successful implementation of new protein biomarkers in the diagnostic arena. New approaches to proteomics biomarker discovery and validation may be the key to boosting clinical proteomics into diagnostics.
Objective: To review the technologies and the mindsets behind proteomic biomarker discovery and discuss suitable methods for the detection of protein variants and their use as potential biomarkers of disease states.
Methods: A literature review of recent research on proteomic biomarkers and through experience with biomarker discovery research was surveyed and described. Emphasis was placed on top-down proteomics approaches for the discovery and routine screening of protein variation.
Conclusion: Protein variation is an untapped resource in the biomarker space, but only a selected few forms of proteomics applications are suitable for their analysis. Such variation could have a significant impact in disease diagnostics and therapeutic intervention.