Illumina enhances flagship assay to accelerate access to comprehensive tumor profiling

Illumina TruSight™ Oncology 500 v2 research assay is now available with built-in HRD biomarker detection, faster turnaround time, and lower tissue sample input

Illumina's growing research and clinical oncology portfolio broadens access to critical biomarker testing

SAN DIEGO, July 30, 2025 /PRNewswire/ -- Illumina Inc. (NASDAQ: ILMN) today announced the launch of the next generation of TruSight Oncology 500, its flagship cancer research assay that enables comprehensive genomic profiling. Comprehensive genomic profiling (CGP) is a critical tool to accelerate access to precision medicine by providing a molecular tumor profile to labs advancing research in therapy selection and clinical trial eligibility. TruSight Oncology 500 version 2 (TSO 500 v2) offers a streamlined sample-to-analysis workflow and reflects Illumina's commitment to serving customers with the highest quality and most rigorously tested solutions.

"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 of 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."

From a small tissue sample, TSO 500 v2 assesses hundreds of genes across all variant classes and immuno-oncology biomarkers to facilitate therapy selection research. Research shows that when CGP is performed early in a cancer patient's diagnosis, it leads to better personalized treatment and outcomes. 

Faster, easier, more efficient workflow

For the first time, homologous recombination deficiency (HRD) status will be included for all samples analyzed, at no additional cost. HRD analysis is powered by a gold-standard Genomic Instability Scoring (GIS) algorithm licensed from Myriad Genetics. This will expand research into the value of the HRD biomarker in more cancer types.

Early-access customer Weiyi Chen, PhD, HCLD (ABB), technical director, Molecular Diagnostics at siParadigm Diagnostic Informatics, noted the assay's distinct advantages.

"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 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."

Key advantages included in TSO 500 v2:

• Streamlined workflow reduces turnaround time and hands-on time
  
  
• Sensitive variant calling and improved coverage of difficult genomic regions
  
  
• Leverages gold-standard Myriad^® Genomic Instability Score (GIS) algorithm to determine HRD status, included for all samples
  
  
• Improved sustainability: New kit configurations with 50% less packaging, 70% fewer tubes, and improved usability with a color-coded tubing system
  
  
• Integrated and automated data analysis, from sequencer to insights, supported with DRAGEN^™ secondary analysis and Illumina Connected Insights for variant interpretation, or with third-party solutions like Velsera Clinical Genomics Workspace (CGW)
  
  
• Broad platform compatibility across high- and mid-throughput sequencers
  
  
• User-friendly automation kits and methods (coming soon) that furtherreduce turnaround time andhands-on time compared to the manual workflow

Another early access customer, Conxi Lázaro, PhD, lab director at the Catalan Institute of Oncology, noted the impact of the updated packaging and kit configuration on the user experience: "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."

Illumina's oncology portfolio

Illumina has established and continues to invest in research and clinical solutions to bring advanced tumor profiling technologies to scale and address customers' broad range of biomarker profiling needs.

The TruSight Oncology portfolio encompasses research-use-only (TSO 500 products) and in vitro diagnostic (TSO Comprehensive) solutions across a range of mid- and high-throughput instrumentation. 

Through a partnership with Pillar BioSciences, Illumina also offers customers targeted molecular profiling tests. Earlier this year, Illumina announced the addition of the Pillar oncoReveal CDx IVD kit to its portfolio. The kit will be available to order later this quarter.

Learn more about TSO 500 v2.

Use of forward-looking statements

This release may contain forward-looking statements that involve risks and uncertainties. Among the important factors to which our business is subject that could cause actual results to differ materially from those in any forward-looking statements are: (i) challenges inherent in developing, manufacturing, and launching new products and services; (ii) customer uptake of, and satisfaction with, new products and services; (iii) our ability to manufacture robust instrumentation and consumables; (iv) the future conduct and growth of the business and the markets in which we operate; and (v) legislative, regulatory and economic developments, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts' expectations, or to provide interim reports or updates on the progress of the current quarter.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit illumina.com and connect with us on X, Facebook, LinkedIn, Instagram, TikTok, and YouTube.

Contacts
Investors:
Brian Blanchett
IR@illumina.com

Media:
Christine Douglass
PR@illumina.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/illumina-enhances-flagship-assay-to-accelerate-access-to-comprehensive-tumor-profiling-302517047.html

SOURCE Illumina, Inc.