Science Inventory

Towards Omics Reporting Standards in Regulatory Toxicology: Introducing the OECD Transcriptomics and Metabolomics Reporting Framework

Citation:

Yauk, C., J. Harrill, M. Viant, AND M. Sachana. Towards Omics Reporting Standards in Regulatory Toxicology: Introducing the OECD Transcriptomics and Metabolomics Reporting Framework. Environmental Mutagenesis and Genomics Society, NA (Virtual), NC, September 22 - 25, 2021. https://doi.org/10.23645/epacomptox.25749375

Impact/Purpose:

Presentation to the Environmental Mutagenesis and Genomics Society meeting September 2021. The Organization for Economic Cooperation and Development (OECD) Extended Advisory Group for Molecular Screening and Toxicogenomics (EAGMST) initiated a project aimed at developing a reporting framework for omics toxicology studies to promote regulatory acceptance and use of omics data in risk assessment applications.  This presentation describes progress towards development of this omics reporting framework. The information would be of interest to those contemplating the use of omics data in regulatory decision making.

Description:

Omics methodologies are increasingly used to inform human health risk assessment. The volume of transcriptomic data in particular has grown markedly with the commercialization of targeted sequencing approaches that enable high-throughput gene expression profiling. These technologies are now widely used to inform mode of action, chemical potency, and similarity of biological responses across chemicals. Despite widespread use, regulatory acceptance and uptake has been hindered by several barriers to routine application including: 1) lack of transparency for data processing methods that produce the final outputs from the raw omics data; and 2) lack of standardization in reporting to ensure that omics data, associated metadata and the methodologies used to generate results are available for review by stakeholders, including regulators. These barriers also contribute to the lack of reproducibility of data outputs that are challenges to the omics community at large. To address these obstacles, the Organisation for Economic Co-operation and Development (OECD) Extended Advisory Group on Molecular Screening and Toxicogenomics launched a project to develop guidance for the reporting of omics data aimed at fostering further regulatory use. This presentation summarizes work to date, which has produced a single harmonized, integrated framework that at present includes the Transcriptomics Reporting Framework (TRF) and the Metabolomics Reporting Framework (MRF). The reporting framework is developed using a modular structure to readily enable updates. At present both the TRF and MRF are being trialled by users and end-users to confirm clarity, completeness, utility and ease of use. This abstract does not reflect USEPA policy.

Record Details:

Record Type:DOCUMENT( PRESENTATION/ SLIDE)
Product Published Date:09/25/2021
Record Last Revised:05/07/2024
OMB Category:Other
Record ID: 361362