On November 19, 2024 Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, reported that it will release TruSight Oncology 500 v2 (TSO 500 v2), a new version of its flagship cancer research assay to enable comprehensive genomic profiling (CGP) (Press release, Illumina, NOV 19, 2024, View Source [SID1234648507]). The assay is currently under development, with global release planned for mid-2025. Detailed plans for the product will be shared November 21 in a spotlight presentation at the annual meeting of the Association of Molecular Pathology (AMP) in Vancouver, British Columbia.

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TSO 500 v2 assesses hundreds of genes across all variant classes, and immuno-oncology biomarkers, in a single assay from one sample, to facilitate therapy selection research.

Key features of TSO 500 v2 include:

Faster turnaround time and reduced hands-on time
Sensitive variant calling and improved coverage of difficult genomic regions
Gold-standard Myriad Genomic Instability Score (GIS) to determine homologous recombination deficiency (HRD) status, included for all samples
New kit configurations with 50% less packaging, 70% fewer tubes, and improved usability
Automation methods available with flexible batch sizes
Integrated and automated data analysis, from sequencer to insights supported with DRAGEN secondary analysis and Illumina Connected Insights, or Velsera’s Clinical Genomics Workspace (CGW)
Broad platform compatibility
At AMP, several abstracts accepted for poster presentations will demonstrate preliminary analytical performance data and automation compatibility of TSO 500 v2. The studies support the assay’s applications for clinical research in identifying rare genetic biomarkers and fusion biomarkers.

TSO 500 v2 early access customer response

Wei Song, MD, PhD, director of Clinical Genomics and Molecular Pathology at the University of California, San Diego, is an early access customer testing TSO 500 v2.

"We are excited to assess the new features of the TruSight Oncology 500 v2 tissue assay, such as the faster workflow, improved coverage, and lower DNA/RNA input levels," he said. "Such improvements are highly relevant to clinical research laboratories and can positively affect time to results, quality of results, and the processing of challenging tissue samples."

TruSight Oncology portfolio enables clinical research and in-vitro diagnostic CGP solutions

Illumina’s oncology portfolio has evolved over time to fit customers’ diverse needs for versatility and scalability. The TSO portfolio encompasses research-use-only (TSO 500 products) and in-vitro diagnostic (TSO Comprehensive) solutions across a range of low-, mid-, and high-throughput instrumentation. Illumina also announced today that TSO Comprehensive kits are now available to ship. In August, the company announced FDA approval of its TSO Comprehensive test and its first two companion diagnostic indications.

"In listening to our broad range of customers, we understand there are different needs for biomarker profiling, and Illumina has successfully introduced a continuum of solutions to address varying levels of need," said Traci Pawlowski, vice president of Clinical Solutions at Illumina.

CGP is a critical tool for identifying actionable alterations, including rare mutations, which enables precision medicine in accordance with professional guidelines. At AMP, several customer-led poster presentations will provide further evidence for the clinical utility of CGP and demonstrate its versatility in hospital and community oncology care settings.

Illumina will cohost a workshop with Bayer, featuring a panel discussion of key opinion leaders on the challenges and practice gaps in precision medicine implementation, and the coordination of a multidisciplinary team to ensure optimal biomarker detection and targeted therapy utilization