Overview

The Illumina DRAGEN TruSight Oncology 500 ctDNA Analysis Software supports analysis for DNA libraries that are isolated from plasma and prepared using the TruSight Oncology 500 ctDNA v2 and v1 assays. The software produces a variant call file (*.vcf) for small variants. Reports include mutations per megabase scores for tumor mutational burden (TMB), a Jensen-Shannon distance (sum JSD) score that can be used for evaluating microsatellite instability (MSI) status, small variant, copy number variation (CNV), and DNA fusion.

The secondary analysis software starts from a sequencing run folder containing base call files (BCL) or from FASTQ files staged in a FASTQ folder.

The DRAGEN TruSight Oncology 500 ctDNA Local Analysis Software uses the Illumina DRAGEN Bio-IT Platform, a specialized server and software package, to run the secondary analysis.

This document provides an overview of the DRAGEN TruSight Oncology 500 ctDNA Local Analysis Software, workflow, computing requirements, installation, analysis software, analysis methods, and analysis outputs. Use of the software requires basic knowledge of the Linux operating system and the Docker software container platform.

The DRAGEN TruSight Oncology 500 ctDNA Local Analysis Software is optimized for analyzing sequencing outputs generated by the TruSight Oncology 500 ctDNA v2 and v1 assays. Modification might lead to inaccurate data and is a violation of the Illumina End-User License Agreement. Refer to your end-user license agreement for complete terms.

Refer to the Illumina DRAGEN Analysis Workflows Product Documentation for more information on the analysis methods used in the DRAGEN TruSight Oncology 500 ctDNA Local Analysis Software.

Compatibility with Illumina Systems

For information on sequencing compatibility and settings, refer to the TruSight Oncology 500 ctDNA support page on the Illumina support site.