Illumina Announces Upcoming Launch of Redesigned TruSight Oncology 500 v2 Assay

Illumina, Inc., a prominent entity in DNA sequencing and array technology, has revealed plans to debut TruSight Oncology 500 v2 (TSO 500 v2), an updated version of its leading cancer research assay aimed at facilitating comprehensive genomic profiling (CGP). The assay is presently in the development phase, with a worldwide introduction anticipated for mid-2025. More information will be divulged on November 21 during a featured presentation at the annual Association of Molecular Pathology (AMP) meeting in Vancouver, British Columbia.

### Enhancements and Features of TSO 500 v2
TSO 500 v2 brings several notable advancements, including quicker processing with less manual intervention, enhanced sensitivity for variant detection, and improved analysis of challenging genomic regions. Incorporation of the Myriad Genomic Instability Score (GIS) for determining homologous recombination deficiency (HRD) is offered for all processed samples, alongside new kit designs, reducing packaging by 50%, tubes by 70%, and simplifying usability. The assay also supports automation with adaptable batch sizes and offers integrated data analysis capabilities, backed by DRAGEN secondary analysis, Illumina Connected Insights, or Velsera’s Clinical Genomics Workspace (CGW), ensuring compatibly with a wide array of platforms.

At the AMP meeting, multiple abstracts accepted for poster presentations will showcase preliminary analytical performance metrics and automation compatibility of TSO 500 v2. These studies underline the assay’s utility in clinical research for detecting unique genetic and fusion biomarkers.

### Response from Early Access Customers
Dr. Wei Song, director of Clinical Genomics and Molecular Pathology at the University of California, San Diego, is among early testers of TSO 500 v2.

“We are thrilled to evaluate the distinct improvements in the TruSight Oncology 500 v2 tissue assay, particularly its expedited workflow, expanded genomic coverage, and reduced DNA/RNA input requirements,” he stated. “Such advancements are crucial for clinical research laboratories and can significantly impact both result timing and quality, as well as the handling of complex tissue samples.”

### Alignment with Precision Medicine
Illumina’s oncology suite has matured over time to accommodate the varied requirements of customers for adaptability and scale. The TSO series includes research-ready (TSO 500 products) and diagnostic (TSO Comprehensive) options across different throughput levels. Furthermore, Illumina has announced the availability of TSO Comprehensive kits for shipping and, in August, detailed FDA approval of its TSO Comprehensive test alongside its initial companion diagnostic indications.

“By engaging with our extensive customer base, we recognized the diverse demands for biomarker analysis, leading to a successful introduction of an array of solutions tailored to different requirements,” noted Traci Pawlowski, Vice President of Clinical Solutions at Illumina.

CGP remains vital for unearthing actionable genomic changes, including rare variants, thereby fostering precision medicine aligned with professional standards. During AMP, several client-driven presentations will offer additional evidence backing the clinical value of CGP, showcasing its adaptability in both hospital and community oncology environments.

Illumina will also lead a workshop in collaboration with Bayer, including a panel discussion with experts focusing on the obstacles and practice gaps in precision medicine, emphasizing the importance of a multidisciplinary approach for effective biomarker analysis and targeted therapy application.

Illumina is at the forefront of enhancing human health through leveraging genomic insights, an emphasis on innovation positioning them as a global frontrunner in DNA sequencing and array-based technologies across research, clinical, and applied sectors.