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Updated: Oct 5, 2025

Droplet Barcoding-Based Single Cell Transcriptomics of Adult Mammalian Tissues

Droplet Barcoding-Based Single Cell Transcriptomics of Adult Mammalian Tissues

Published on: January 10, 2019

Communicating regulatory high-throughput sequencing data using BioCompute Objects.

Charles Hadley S King¹, Jonathon Keeney², Nuria Guimera³

¹The Department of Biochemistry & Molecular Medicine, The George Washington University Medical Center, Washington, DC 20037, USA; The McCormick Genomic and Proteomic Center, The George Washington University, Washington, DC 20037, USA.

Drug Discovery Today

|January 25, 2022

Summary

This summary is machine-generated.

The IEEE 2791-2020 Standard (BioCompute Objects [BCO]) enhances next-generation sequencing (NGS) analysis communication. A template BCO (tBCO) with a verification kit improved transparency and reproducibility in simulated regulatory submissions.

Keywords:

Amino acid substitutions Antiviral resistance BioCompute Objects HCV1a Next generation sequencing (NGS)Regulatory submission Single nucleotide polymorphism (SNP)

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Area of Science:

Bioinformatics
Computational Biology
Genomics

Background:

Next-generation sequencing (NGS) analysis generates complex data requiring robust communication methods.
The IEEE 2791-2020 Standard for BioCompute Objects (BCO) aims to standardize the description of computational analyses.
Ensuring reproducibility and transparency in regulatory submissions is critical for pharmaceutical development.

Purpose of the Study:

To demonstrate the utility of BioCompute Objects (BCO) for transparent and reproducible communication of NGS analysis results.
To evaluate the effectiveness of a template BCO (tBCO) in a simulated regulatory submission and review process.
To assess the concordance of independent analyses using BCO-defined data.

Main Methods:

Replication of a clinical trial arm using synthetic, biologically relevant data.
Two independent analyses were performed: one simulating a regulatory submission with a BCO, and another simulating an FDA review.
A template BCO (tBCO) and verification kit were utilized to standardize the analysis description.

Main Results:

High agreement (99.15%) was observed between the two independent analyses of 118 simulated patient samples.
The BCO facilitated the clear communication of NGS analysis results for regulatory purposes.
The tBCO and verification kit demonstrated effectiveness in promoting transparency and reproducibility.

Conclusions:

The IEEE 2791-2020 Standard (BCO) effectively enables complete and concise communication of NGS analysis results.
Template BCOs (tBCOs) with verification kits enhance transparency and reproducibility in simulated regulatory submissions.
This approach strengthens confidence in the pharmaceutical regulatory submission and review process.