Journal
ARCHIVES OF TOXICOLOGY
Volume 95, Issue 11, Pages 3475-3495Publisher
SPRINGER HEIDELBERG
DOI: 10.1007/s00204-021-03150-9
Keywords
microRNA; Biomarker; Drug Safety; Systems Biology; Toxicology; DILI
Categories
Funding
- MRC Centre for Drug Safety Science [MR/L006758/1]
- TransBioLine
- Innovative Medicines Initiative 2 Joint Undertaking [821283]
- European Union's Horizon 2020 research and innovation programme
- EFPIA
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miRNAs are short non-coding RNA molecules that have been shown to be dysregulated and released in different organ systems. Circulating miRs are proposed as useful biomarkers for various disease states, potentially replacing existing traditional biomarkers. However, pre-analytical and analytical challenges need to be addressed before their clinical use can be realized.
microRNAs (miRNAs or miRs) are short non-coding RNA molecules which have been shown to be dysregulated and released into the extracellular milieu as a result of many drug and non-drug-induced pathologies in different organ systems. Consequently, circulating miRs have been proposed as useful biomarkers of many disease states, including drug-induced tissue injury. miRs have shown potential to support or even replace the existing traditional biomarkers of drug-induced toxicity in terms of sensitivity and specificity, and there is some evidence for their improved diagnostic and prognostic value. However, several pre-analytical and analytical challenges, mainly associated with assay standardization, require solutions before circulating miRs can be successfully translated into the clinic. This review will consider the value and potential for the use of circulating miRs in drug-safety assessment and describe a systems approach to the analysis of the miRNAome in the discovery setting, as well as highlighting standardization issues that at this stage prevent their clinical use as biomarkers. Highlighting these challenges will hopefully drive future research into finding appropriate solutions, and eventually circulating miRs may be translated to the clinic where their undoubted biomarker potential can be used to benefit patients in rapid, easy to use, point-of-care test systems.
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