Proteomics beyond proteomics: toward clinical applications.

PURPOSE OF REVIEW: There is an increasing interest in the application of proteomics in all areas of the life sciences, especially in the area of biomedical research wherein the analysis of biological fluids is very promising for biomarker discovery. The rapid development of proteomics as a field has depended upon substantial advances in instrumentation, methodologies, software and the availability of comprehensive sequence databases. However, progress has been slower than anticipated with respect to application in the realm of biomedicine. RECENT
FINDINGS: We review some of the areas of importance for the development of proteomics and its applications to biomedical research.
SUMMARY: One of the factors explaining the slow progress of candidate proteomics biomarkers through the translational pipeline has been the difficulty to develop validation and standardization of procedures to improve reproducibility, sensitivity and specificity. This challenge has now largely been met by large, consortium efforts, leading to the discovery of drug-specific protein biomarkers. The need for integrating complex protein patterns is now recognized in a new test classification by the US Food and Drug Administration termed 'in-vitro diagnostic multivariate index assays'. Further progress in clinical proteomics will depend upon continued collaborative efforts and infrastructure development by the proteomics community.