Science Inventory

Methodological considerations for measuring biofluid-based microRNA biomarkers

Citation:

Chorley, B., E. Atabakhsh, G. Doran, J. Gautier, H. Ellinger-Ziegelbauer, D. Jackson, T. Sharapova, P. Yuen, R. Church, P. Couttet, R. Froetschl, J. McDuffie, V. Martine, P. Pande, L. Peel, C. Rafferty, F. Simutis, AND A. Harrill. Methodological considerations for measuring biofluid-based microRNA biomarkers. CRITICAL REVIEWS IN TOXICOLOGY. Taylor & Francis Group, London, Uk, 51(3):264-282, (2021). https://doi.org/10.1080/10408444.2021.1907530

Impact/Purpose:

For the Agency, mechanistic-based biomarkers are important, accessible measurements to determine the biological state of an organism/tissue/cell given an environmental and/or chemical exposure. These types of measurements will assist next generation risk assessors in determining the biological impact of chemical exposure in in vitro, in vivo, and in the human population. Specifically, microRNAs are promising, biofluid-based biomarkers that can non-invasively be measured and linked to the mechanism of action of toxicity. However, these measurements have multiple technical challenges and this article articulates what we must do as a scientific community to overcome them. The authors are part of a multi-institutional workgroup (Health and Environmental Sciences Institute Committee on Emerging Systems Toxicology for the Assessment of Risk) focused on the use of miRNAs for regulatory, safety, drug development, and academic purposes.

Description:

MicroRNAs (miRNAs) are small non-coding RNA that regulate the expression of messenger RNA and are implicated in almost all cellular processes. Importantly, miRNAs can be released extracellularly and are stable in these matrices where they may serve as indicators of organ or cell-specific toxicity, disease, and biological status. There has thus been great enthusiasm for developing miRNAs as biomarkers of adverse outcomes for scientific, regulatory, and clinical purposes. Despite advances in measurement capabilities for miRNAs, miRNAs are still not routinely employed as noninvasive biomarkers. This is in part due to the lack of standard approaches for sample preparation and miRNA measurement and uncertainty in their biological interpretation. Members of the microRNA Biomarkers Workgroup within the Health and Environmental Sciences Institute’s (HESI) Committee on Emerging Systems Toxicology for the Assessment of Risk (eSTAR) are a consortium of private- and public-sector scientists dedicated to developing miRNAs as applied biomarkers. Here, we explore major impediments to routine acceptance and use of miRNA biomarkers and case examples of successes and deficiencies in development. Finally, we provide insight on miRNA measurement, collection, and analysis tools to provide solid footing for addressing knowledge gaps toward routine biomarker use.

Record Details:

Record Type:DOCUMENT( JOURNAL/ PEER REVIEWED JOURNAL)
Product Published Date:05/26/2021
Record Last Revised:06/08/2021
OMB Category:Other
Record ID: 351873