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Various chemical substances and drugs that are indispensable in daily life also carry a potential risk of harm to human health and the environment; therefore, in order to avoid health crises and maintain public safety, it is necessary to accurately estimate the risk carried by exposures to chemical substances and drugs.

Through the accumulation of toxicogenomics data collected during a single exposure to a chemical substance or drug, the highly accurate impact assessment of chemical substances and drugs on the basis of their molecular mechanisms is reaching the stage of practical use. However, these data are derived from specific organs (mainly the liver), and comprehensive toxicity evaluation at the individual level is both costly and labor-intensive.

Recent reports demonstrate that EVs circulating in various fluids could be used as diagnostic biomarkers for various cancers (Logozzi et al. 2009; Lu et al. 2009; Rabinowits et al. 2009; Choi et al. 2011). These EV-associated biomarkers are more sensitive and accurate than biomarkers that are currently widely used, such as CEA for adenocarcinoma and PSA for prostate cancer. Furthermore, microRNAs contained in EVs secreted from various cell types and human samples are being identified as specific biomarkers for chemically induced inflammation (Mobarrez et al. 2014; Li et al. 2010; Baek et al. 2016; Bala et al. 2012; Cho et al. 2017). In addition, EV-associated miRNAs are well protected owing to the lipid bilayer membrane of EVs, even in EVs that have been purified from the circulating bloodstream (Yanez-Mo et al. 2015).

Therefore “next-generation type” toxicity tests for chemical substances and drugs were developed by using EV-associated miRNAs in blood as biomarkers (Figure 3.7).

Figure 3.7 Schematic representation of toxicity testing using EVs as biomarkers.