The latest solutions will be showcased at the Annual Meeting of the Society for Molecular Pathology, aimed at achieving panoramic mutation analysis of tumors.

Research and sharing led by Illumina customers will provide the latest evidence and related content for tumor analysis.

San Diego, California, USA, November 20, 2024 /PR Newswire/ -- Illumina, the global leader in DNA sequencing and array technologies (NASDAQ: ILMN), today announced the launch of a new version of its flagship cancer research assay, TruSight Oncology 500 v2 (TSO 500 v2), for comprehensive genomic profiling (CGP). The assay is currently under development and is scheduled for a global release in mid-2025. Detailed plans for the product will be shared during a presentation at the Annual Meeting of the Society for Molecular Pathology (AMP) in Vancouver, British Columbia, Canada on November 21.

TSO 500 v2 will be able to assess all mutation types and immuno-oncology biomarkers across hundreds of genes in a single assay to aid research for treatment options. Key features of TSO 500 v2 include:

• Faster turnaround times and shorter manual operation times.
• More sensitive variant detection and better optimized coverage of difficult gene detection regions.
• Provide a gold standard Myriad Genomic Instability Score (GIS) for all samples to determine homologous recombination deficiency (HRD) status.
• The new kit configuration reduces packaging by 50%, decreases the number of test tubes by 70%, and improves usability.
• Provides flexible, automated methods for batch processing.
• Automated integration of data analysis from sequencing to reporting, supporting DRAGEN secondary analysis and PerkinElmer Connected Insights, or Velsera Clinical Genomics Workspace (CGW).
• Wide platform compatibility.

At the AMP conference, several abstracts accepted for poster presentations will focus on preliminary analysis performance data and automation compatibility of TSO 500 v2. These studies support the application of this assay in clinical research to identify rare gene biomarkers and fusion biomarkers.

Feedback from early users of TSO 500 v2

Dr. Wei Song, 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 the TruSight Oncology 500 v2 tissue test, such as faster workflows, improved coverage, and lower DNA/RNA input requirements. These improvements are highly relevant to clinical research laboratories and can positively impact turnaround times, result quality, and handling challenging tissue samples."

The TruSight Oncology product line supports comprehensive genomic profiling (CGP) solutions for clinical research and in vitro diagnostics.

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

According to Traci Pawlowski, Vice President of Clinical Solutions at Invenia: "Through extensive listening to our customers, we learned that there are different needs for biomarker analysis, and Invenia has successfully introduced a series of solutions to meet these different levels of demand."

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

Invenia will co-host a seminar with Bayer, where industry opinion leaders will discuss and share the challenges and practice gaps in the implementation of precision medicine, as well as how to coordinate multidisciplinary teams to ensure the optimal use of biomarker testing and targeted treatments.

For information on Invenia's seminars and speaking list at the AMP conference, please visit the company's events page.

Forward-looking statements

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About Infinera

Infinera is committed to advancing and enhancing genomics development to improve human health. Our focus on innovation has made us a global leader in gene sequencing and chip technology, providing professional services to research, clinical, and application market customers worldwide. Our products are widely used in life sciences, oncology, reproductive health, agriculture, and other emerging fields. For more information, please visit or follow Infinera's WeChat public account.