The important role of standards for the uptake of transcriptomics and metabolomics based in vitro methods in regulatory toxicology

Abstract

Driven by increasing regulatory interest in applying omics-based methods and reducing animal testing, this study reviewed existing documentary standards for transcriptomics and metabolomics, focusing on those applicable to in vitro test systems. Investigation revealed the landscape to be heterogeneous: for transcriptomics (using RNA-seq), some documentary standards have been produced by formal standardisation bodies (e.g., International Organization for Standardization), whilst for metabolomics (using MS), these were primarily driven by the work of the scientific community developing best practices. The value of reference materials is also highlighted since they enable characterisation of both (analytical) intra-laboratory repeatability and reproducibility as well as inter-laboratory reproducibility. Leveraging standards within omics-based in vitro methods that enter the OECD Test Guideline Programme will ensure their reliability, accessibility across jurisdictions, and sustainability for their long-term use. These benefits are explained with practical examples and make the case for better use of existing standards and initiating targeted development of new standards for efficient and effective development of international Test Guidelines based on in vitro transcriptomics and metabolomics methods.