Illumina Launches Advanced Liquid Biopsy Assay to Enable Comprehensive Genomic Profiling in Solid Tumors

TSO 500 ctDNA 2.0The version offers faster turnaround times, higher analytical sensitivity, and a more streamlined workflow.Further Advance the Development of Precision Medicine

San Diego, California, November 3, 2023 /PRNewswire/ --November 1,Global Genomics and Chip Technology Leader Illumina, Inc. (NASDAQ: ILMN) Announces Launch of Next-Generation Liquid Biopsy Genomic Analysis Product. The new TruSight™ Oncology 500 ctDNA v2 (TSO 500 ctDNA v2) is a research-use-only test that enables non-invasive comprehensive genomic profiling (CGP) of circulating tumor DNA (ctDNA) in blood when tissue testing is not feasible or requires supplementation with tissue-based testing.

The innovations of this product include: faster turnaround time from sample to result (less than four days), higher sensitivity, lower starting input requirements for cell-free DNA (cfDNA), a more streamlined and efficient workflow, and anticipated further automation in the first half of 2024.

Kevin Keegan, General Manager of Illumina's Oncology Division, stated: "Leading cancer centers in the industry are increasingly adopting comprehensive genomic profiling based on liquid biopsy. Our goal in launching the TSO 500 ctDNA v2 assay is to help customers integrate analytical results more conveniently, thereby deepening insights into cancer research."

Important Innovation

Nine institutions are participating in Illumina's global early access program, testing the TSO 500 ctDNA v2. Professor Giancarlo Pruneri of Pathology at the University of Milan School of Medicine and Head of the Pathology and Experimental Medicine Unit at the National Cancer Institute of Milan stated that their preliminary tests of the new version of the TSO 500 ctDNA panel in the laboratory have "undoubtedly shown improvements over the previous version."

"It is worth mentioning that the optimization of the library preparation process saved a working day, allowing us to proceed with molecular analysis more quickly," he stated. "At the same time, the detection sensitivity is higher, supporting the analysis of samples with low DNA content (20 ng), potentially expanding the application scope of liquid biopsy testing."

As the evidence for the utility and effectiveness of liquid biopsy CGP continues to accumulate, the technology has now been incorporated into recommended oncology professional guidelines. Notably, for non-small cell lung cancer, liquid biopsy testing has demonstrated its application value when tissue test results are unavailable or can only be obtained with a delay. This trend is expected to extend to other malignant solid tumors, further validating our concept of conducting extensive tumor analysis on cfDNA in the blood before tissue analysis.

"On the other hand, traditional tissue analysis is often limited by the availability of tissue, usually involving expensive invasive biopsy procedures," Pruneri said. "In this context, Illumina's new panel has emerged to address the reliance on tissue availability."

The automated reagent kit and testing method配套的自动化试剂盒以及检测方法 for TSO 500 ctDNA v2 are expected to launch in the first half of 2024, enabling laboratories to expand in response to the growing demand for this technology.

AboutTruSight Oncology 500 ctDNA v2

TSO 500 ctDNA v2 is a comprehensive pan-cancer detection product for research use only, capable of identifying 523 known and emerging tumor biomarkers in plasma. TSO 500 ctDNA v2 utilizes cfDNA from liquid biopsy samples to detect key variants critical to cancer development and progression, such as small DNA variants (SV), copy number variations (CNV), short and long insertions and deletions (indel), as well as immuno-oncology gene signatures like tumor mutation burden (bTMB) and microsatellite instability (bMSI). This liquid biopsy-based comprehensive variant analysis assay features content and design similar to the tissue-based TSO 500 assay, offering a range of solutions. Supported by robust DRAGEN bioinformatics, the performance and flexibility of the TSO 500 ctDNA v2 solution are enhanced. For more information on TSO 500 ctDNA v2,Please click here.

Forward-Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties, including expectations regarding reduced costs associated with genomic data storage and management. Important factors that could cause actual results to differ materially from those in any forward-looking statements include: (i) the challenges inherent in developing and launching new products and services, including meeting production, quality, and performance requirements; (ii) our ability to deploy new products, services, and applications and expand the market for our technology platforms; and (iii) customer acceptance of new products, which may or may not meet our and their expectations after deployment, as well as other factors detailed in our filings with the Securities and Exchange Commission, including our most recent 10-K and 10-Q forms, or information disclosed during public conference calls, for which dates and times have been announced in advance. We have no obligation to update these forward-looking statements, nor do we intend to assess or confirm analysts' related expectations, provide interim reports for the quarter, or update documents.

About Illumina

Illumina, Inc. is committed to advancing and inspiring genomics to continuously improve human health. In 2023, Illumina celebrated its 25th anniversary. Over 25 years of innovation have established us as a global leader in sequencing and array technologies, providing specialized services to customers in research, clinical, and applied markets worldwide. Our products are widely used in life sciences, oncology, reproductive health, agriculture, and other emerging fields. For more information, please visitwww.illumina.com.cnOr follow the Illumina WeChat Official Account.