Communicating regulatory high-throughput sequencing data using BioCompute Objects

•We designed this study to demonstrate the use of BioCompute Objects (BCO) to communicate results, obtained from next generation sequencing (NGS) data collected during a clinical trial, to a regulatory agency.•The BCO framework facilitates transparency and reproducibility, thereby reinforcing trust in the regulatory submission process.•A template BCO makes benchmarking and direct comparisons between different analysis pipelines more feasible.•The outcomes of this project indicate that BCO can capture the data processing workflow and can facilitate the submission of analyses to the US Food and Drug Administration (FDA).•We demonstrate the ability of a template BCO, with a verification kit, to communicate NGS analyses clearly within regulatory submissions.