Illumina Launches Next Generation of its Liquid Biopsy Assay for Cancer Genomic Profiling; Offers Key Workflow Enhancements and Increased Sensitivity

11-1-23 (by: Scott Gleason) Illumina  has launched the latest generation of its distributed liquid biopsy assay for comprehensive genomic profiling with the new TruSight™ Oncology 500 ctDNA v2 (TSO 500 ctDNA v2).

The key enhancements incorporated into the TSO 500 ctDNA v2 assay include a sample-to-answer turnaround time of under four days. The reduced library preparation time, streamlined through a single hybridization step, contributes to this faster process. Most ctDNA CGP assays typically require a week or more for results. The quick turnaround enables researchers to gather valuable insights sooner, thereby enhancing precision oncology efforts. The assay can also effectively analyze genomic material from as little as 5 to 30 nanograms (ng) of cell-free DNA input. At 20 ng input, it demonstrates over 95% analytical sensitivity and 99.9995% specificity and at 10 ng input, it maintains over 95% sensitivity for hotspot mutations with 99.9995% specificity. This heightened performance is attributed to innovations in chemistry and advanced variant analysis software. The TSO 500 ctDNA v2 assay also offers a versatile, end-to-end solution available in both manual and automated formats. Workflow enhancements significantly reduce hands-on time during library preparation. Moreover, the inclusion of automated bioinformatics features further streamlines the process. The assay’s compatibility with sequencing on the NovaSeq 6000, including the NovaSeq X scheduled for 2024. The company also plans to launch workflow automation solutions in the first half of 2024. Nine academic institutions are currently participating in Illumina’s global early-access customer program, where they are testing the TSO 500 ctDNA v2.

Giancarlo Pruneri, a professor of Pathology at the University of Milan School of Medicine, and chair of the Department of Pathology and Laboratory Medicine at the National Cancer Institute of Milan, commended the new version of the TSO 500 ctDNA panel, highlighting improvements in the library preparation protocol that saved time and increased assay sensitivity. These advantages make molecular analysis delivery faster and extend the utility of liquid biopsy testing.