Issues in applying protein biomarkers identified by proteomics to clinical testing

抄録

With recent advances in proteomics technology, many new biomarkers have been reported, but only a few have been clinically applied. In this article, we investigated the possibility of clinical application of new tumor marker candidate proteins discovered through proteomic analysis. We have previously reported novel biomarker candidate proteins in serum extracellular vesicles of colorectal cancer patients using targeted proteomic analysis. In order to apply it to clinical tests, we investigated whether it could be reproduced using ELISA, which is currently the mainstream protein measurement method in clinical tests. As a result, although proteomic analysis was able to distinguish between colorectal cancer patients and healthy controls with high accuracy, ELISA was unable to do so. This may be because the sensitivity of MS for measuring trace amounts of proteins is higher than that of ELISA, or because the detection sensitivity of MS or ELISA depends on the state of the protein such as protein localization, stability and post-translational modification. We will discuss why it is difficult to clinically apply biomarkers identified through proteomic analysis, the causes, and solutions.