Communicating regulatory high- throughput sequencing data using BioCompute Objects

Charles H. King

doi:10.1016/j.drudis.2022.01.007

Communicating regulatory high- throughput sequencing data using BioCompute Objects

2022-04-01

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DOI：10.1016/j.drudis.2022.01.007

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This project demonstrates the use of the IEEE 2791-2020 Standard (BioCompute Objects [BCO]) to enable the complete and concise communication of results from next generation sequencing (NGS) analysis. One arm of a clinical trial was replicated using synthetically generated data made to resemble real biological data and then two independent analyses were performed. The first simulated a pharmaceutical regulatory submission to the US Food and Drug Administration (FDA) including analysis of results and a BCO. The second simulated an FDA review that included an independent analysis of the submitted data. Of the 118 simulated patient samples generated, 117 (99.15%) were in agreement in the two analyses. This process exemplifies how a template BCO (tBCO), including a verification kit, facilitates transparency and reproducibility, thereby reinforcing confidence in the regulatory submission process.

Keywords:

Next generation sequencing (NGS)

Regulatory submission

BioCompute Objects

HCV1a

Antiviral resistance

Single nucleotide polymorphism (SNP)

Amino acid substitutions

Communicating regulatory high- throughput sequencing data using BioCompute Objects

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