Illumina Boosts Assay for Faster Tumor Profiling

Illumina Launches Next-Generation TruSight Oncology 500 v2 to Broaden Access to Comprehensive Tumor Profiling

Illumina Inc., a global leader in DNA sequencing and array-based technologies, has unveiled the next-generation version of its flagship cancer research assay—TruSight Oncology 500 version 2 (TSO 500 v2). This powerful tool for comprehensive genomic profiling (CGP) marks a significant leap forward in precision oncology research. It is designed to accelerate access to molecular tumor insights, supporting research in therapy selection, biomarker analysis, and clinical trial eligibility.

Comprehensive Genomic Profiling: A Critical Asset for Precision Medicine

TSO 500 v2 enables researchers to derive a deep and detailed genomic profile of tumors from a minimal tissue sample, analyzing hundreds of cancer-related genes and variant classes. The latest version integrates several key upgrades that make the assay faster, more sustainable, and easier to use in research labs worldwide. By refining the workflow and reducing tissue requirements, Illumina is addressing a major bottleneck in oncology research: timely and scalable access to comprehensive genomic insights.

“TSO 500 is a trusted assay used by hundreds of researchers worldwide, and these enhancements deliver even greater value for customers with built-in HRD detection, faster turnaround time, and less tissue required,” said Everett Cunningham, Chief Commercial Officer at Illumina. “Customers need complete workflow solutions like this one to enable CGP more efficiently and at scale, ultimately advancing access to tumor profiling and cancer therapy research.”

Key Enhancements in TSO 500 v2: A Step Forward in Performance and Usability

One of the most groundbreaking updates in TSO 500 v2 is the inclusion of homologous recombination deficiency (HRD) status analysis for every sample at no additional cost. HRD is an important biomarker in oncology research, with implications across several cancer types. Illumina’s assay integrates a gold-standard Genomic Instability Scoring (GIS) algorithm licensed from Myriad Genetics, providing robust HRD insights without additional assays or testing burdens.

The new version is not just more informative—it’s also faster and more user-friendly. The workflow has been streamlined to reduce both turnaround and hands-on time, allowing laboratories to generate results more quickly and efficiently. Additionally, packaging and sustainability have been improved significantly, with 50% less packaging and 70% fewer tubes, accompanied by a color-coded tubing system that simplifies setup and minimizes human error.

Customer Feedback Highlights Real-World Benefits

Early access users of TSO 500 v2 have reported notable improvements. Dr. Weiyi Chen, PhD, HCLD (ABB), Technical Director of Molecular Diagnostics at siParadigm Diagnostic Informatics, praised the updated assay for its enhanced accuracy and speed.

“We are very excited about the launch of TSO 500 v2. We found improved accuracy of data results with TSO 500 v2 compared to our current solution from a different vendor,” said Dr. Chen. “The new workflow is fast and streamlined with HRD included. Turnaround time is very important to our lab so we can quickly access results. The solution will also allow us to minimize service costs by consolidating our tests on Illumina sequencers.”

Dr. Conxi Lázaro, Laboratory Director at the Catalan Institute of Oncology, also emphasized the operational advantages. “There are far fewer boxes and tubes to manage, which means we spend less time unboxing and can work faster and more efficiently. Now that the tubes are color coded, there is less room for error, and it is much easier to track the different steps in the workflow.”

Built for the Future: Compatibility, Automation, and Insights

TSO 500 v2 is designed for flexibility and integration across various sequencing platforms. It offers broad compatibility with both high- and mid-throughput sequencers, enabling research institutions of all sizes to adopt the platform with ease.

For data analysis, TSO 500 v2 supports fully integrated solutions, such as Illumina’s DRAGEN™ secondary analysis pipeline and Illumina Connected Insights, which provide streamlined and automated interpretation of complex genomic data. Additionally, the assay can interface with third-party tools like the Velsera Clinical Genomics Workspace (CGW), offering even greater versatility.

To further reduce turnaround time, automation kits and workflows are also in development, enabling high-throughput labs to move away from manual processes without compromising precision or quality.

Illumina’s Expanding Oncology Ecosystem

The launch of TSO 500 v2 underscores Illumina’s ongoing investment in its oncology portfolio. The company has committed substantial resources to expanding both research-use-only and clinical diagnostic solutions.

The TruSight Oncology portfolio now includes TSO 500 products for research and TSO Comprehensive solutions for in vitro diagnostics, covering a wide range of sequencing throughput needs. Through partnerships—such as with Pillar Biosciences—Illumina is also enhancing its offering of targeted molecular profiling assays. Earlier in 2025, the company announced the upcoming availability of the Pillar oncoReveal CDx IVD kit, adding another layer to its expanding menu of precision oncology tools.

Driving the Future of Cancer Research

By delivering greater efficiency, sustainability, and depth of insight, TSO 500 v2 helps unlock the full potential of CGP in cancer research. Its introduction is poised to make personalized treatment research more accessible and impactful across diverse clinical and research environments.

As cancer care continues to evolve toward more individualized approaches, tools like TSO 500 v2 will play a pivotal role in enabling earlier diagnosis, informed therapy selection, and improved outcomes for patients around the globe.

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