Home Illumina Launches Novel Liquid Biopsy and High-Throughput Tumor Profiling Solutions to Expand TruSight Oncology Portfolio

Illumina Launches Novel Liquid Biopsy and High-Throughput Tumor Profiling Solutions to Expand TruSight Oncology Portfolio

Nov 06, 2019 16:53 CST Updated 16:53
Illumina

Diagnostic Product Developer



Customers can perform testing on blood and tissue samples using the NovaSeq™ 6000 Sequencing System.


Illumina Announces Upcoming Launch of Its First Liquid Biopsy Solution for Detecting Cancer Biomarkers—TruSight™ Oncology 500 ctDNA (TSO 500 ctDNA). TSO 500 ctDNA is the latest addition to Illumina’s comprehensive tumor variant analysis portfolio, TruSight Oncology 500 (TSO 500). The previously released TSO 500 was compatible only with the NextSeq 550 and NextSeq 550Dx systems and supported tissue sample testing exclusively.


TSO 500 ctDNA enables non-invasive, comprehensive genomic variant analysis of circulating tumor DNA (ctDNA) when tissue sample testing is not optimal, serving as a complement to tissue-based assays. As Illumina’s first liquid biopsy product capable of comprehensive genomic variant analysis, TSO 500 ctDNA incorporates the exonic sequences of all 523 genes in key cancer-related pathways, detecting single nucleotide variants (SNVs), insertions and deletions (Indels), copy number variations (CNVs), gene fusions, microsatellite instability (MSI), and tumor mutational burden (TMB).


TSO 500 ctDNA can be used on the NovaSeq™ 6000 sequencing system, providing high cost-effectiveness while meeting the requirements of ctDNA for high sensitivity and high specificity sequencing. The new sister product paired with TSO 500 ctDNA on the NovaSeq 6000 system is the large sample volume version of TSO 500—namely, TruSight Oncology 500 High-Throughput (large sample volume solution).


Both products are currently for research use only (RUO) and were launched in early 2020. Illumina has now opened pre-orders for TSO 500 ctDNA.


By providing a complete solution for ctDNA and tissue samples on the NovaSeq 6000, Illumina’s TSO 500 product line now enables high-quality, comprehensive genomic variant analysis from tissue samples to liquid biopsy, allowing users to:

  • Flexibly and efficiently use the same tumor panel to test any sample type on the same sequencing platform

  • Comparison of test results from tissues and blood of single or different individuals

  • Meets the High-Throughput Testing Needs of Large Sample Volumes in Laboratories



“We believe that pan-cancer genomic variant analysis can drive the development of personalized medicine and ultimately improve patient outcomes,” said Carlo Bifulco, Medical Director of the Providence St. Joseph Health Molecular Genomics Laboratory. “Running pan-cancer genomic variant analysis on production-scale sequencers meets our need for high-volume testing, thereby providing guidance for our extensive healthcare system network. These optimized workflows are essential to realizing our vision for precision medicine initiatives.”


Meanwhile, Illumina is collaborating with the Frederick National Laboratory for Cancer Research (FNL), which is sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc., to establish the clinical application of liquid biopsy. The Molecular Characterization Laboratory (MoCHA) at FNL has selected the TSO 500 ctDNA assay to support several NCI-sponsored clinical studies, in which up to 7,000 samples are being evaluated using liquid biopsy.


Dr. P. Mickey Williams, Director of MoCHA, stated that he would continue to use this testing product. “Liquid biopsy approaches have the potential to complement, or in some cases avoid, the need for invasive tissue biopsies,” he said.


Illumina is committed to developing practical and innovative RUO (Research Use Only) kits, which will ultimately greatly expand the range of in vitro diagnostic reagents. Guided by our goal to broaden and enrich our oncology product portfolio, we aim to deliver actionable solutions more rapidly to patients in urgent need of diagnosis and treatment.



Scan the QR code to learn more about TSO 500 ctDNA and TSO 500 High-Throughput, and secure your early reservation for TSO 500 ctDNA.