Illumina Announces Expansion of TruSight Oncology Portfolio with Global Launch of TSO 500 v2 Planned for Mid-2025

China Finance and Economics News, November 20th: Illumina, Inc. (ILMN.NASDAQ) announced yesterday that it will launch a new version of its flagship cancer research testing product, TruSight.^™Oncology 500 v2 (TSO 500 v2) for comprehensive genomic profiling (CGP).

The detection is currently under development and is planned for global release in mid-2025. Detailed plans for the product will be shared during a featured presentation at the Annual Meeting of the Association for Molecular Pathology (AMP) on November 21 in Vancouver, British Columbia, Canada.

TSO 500 v2 will be able to evaluate all variant classes and immuno-oncology biomarkers across hundreds of genes in a single assay to help inform research for treatment selection.

The main features of TSO 500 v2 include: faster turnaround time and shorter hands-on time; more sensitive variant detection and optimized coverage of difficult-to-sequence gene regions; providing the gold standard Myriad for all samples.^®Genomic Instability Score (GIS) to determine Homologous Recombination Deficiency (HRD) status; new kit configuration reduces packaging by 50%, reduces tubes by 70%, and improves usability; provides flexible batch automation methods; automated integrated data analysis from sequencing to report, supports DRAGEN.^™Secondary analysis and Illumina Connected Insights, or Velsera Clinical Genomics Workspace (CGW); extensive platform compatibility.

At the AMP conference, multiple abstracts that have been accepted for poster presentations will collectively showcase the preliminary analytical performance data and automation compatibility of TSO 500 v2. These studies support the application of this assay in clinical research for identifying rare gene biomarkers and fusion biomarkers.

Wei Song, MD, Director of Clinical Genomics and Molecular Pathology at the University of California San Diego, is an early user of TSO 500 v2. He stated, "We are excited to evaluate the new features of TruSight Oncology 500 v2 tissue testing, such as a faster workflow, improved coverage, and reduced DNA/RNA input. These enhancements are highly relevant to clinical research laboratories and can positively impact turnaround time, result quality, and the handling of challenging tissue samples."

According to reports, Illumina's oncology product line continues to update to meet customers' diverse and scalable needs. The TSO product line includes research-use-only solutions (TSO 500 products) and in vitro diagnostic solutions (TSO Comprehensive), suitable for a range of low-, medium-, and high-throughput instruments. Illumina also announced yesterday that the TSO Comprehensive kit is now available for shipping. In August this year, the company announced that its TSO Comprehensive test and its first two companion diagnostic indications received FDA approval.

Traci Pawlowski, Vice President of Clinical Solutions at Illumina, stated: "Through extensive conversations with our customers, we have learned that there are varying needs for biomarker analysis. Illumina has successfully introduced a series of solutions to address these different levels of demand."

Comprehensive variant analysis is an important tool for identifying actionable changes, including rare mutations, which enables precision medicine to be implemented according to professional guidelines. At the AMP conference, multiple poster presentations led by Illumina customers will further provide evidence of the clinical utility of comprehensive variant analysis and demonstrate its applicability in hospital and community oncology care settings.

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