Communicating regulatory high-throughput sequencing data using BioCompute Objects
Drug discovery today
Amino acid substitutions; Antiviral resistance; BioCompute Objects; HCV1a; Next generation sequencing (NGS); Regulatory submission; Single nucleotide polymorphism (SNP)
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.
King, Charles Hadley; Keeney, Jonathon; Guimera, Nuria; Das, Souvik; Weber, Michiel; Fochtman, Brian; Walderhaug, Mark O.; Talwar, Sneh; Patel, Janisha A.; Mazumder, Raja; and Donaldson, Eric F., "Communicating regulatory high-throughput sequencing data using BioCompute Objects" (2022). GW Authored Works. Paper 235.
Biochemistry and Molecular Medicine