Illumina’s TruSight Oncology 500 portfolio currently consists of three research assays that enable pan-cancer comprehensive genomic profiling (CGP). Image credit: Tada Images via Shutterstock.

Illumina will expand its TruSight Oncology portfolio with the introduction of the TruSight Oncology 500 v2 (TSO 500 v2), a new version of its flagship next-generation sequencing (NGS) cancer assay for comprehensive genomic profiling (CGP) of solid tumours.

Currently under development, the US-based biotech is planning for the global release of TSO 500 v2, which can assess hundreds of genes across all variant classes and immuno-oncology biomarkers in a single assay, from a single sample, by mid-2025.

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Key features of TSO 500 v2 include faster turnarounds and reduced hands-on time, sensitive variant calling and improved coverage of difficult genomic regions, and the ability to perform automated data analysis, with insights supported by Illumina’s DRAGEN and Illumina Connected Insights interpretation software, or Velsera’s Clinical Genomics Workspace (CGW).

Dr Wei Song, director of clinical genomics and molecular pathology at the University of California, San Diego, and an early access customer testing the TSO 500 v2, says his team is excited about new features of the tissue assay, including improved coverage and reduced DNA/RNA input levels.

Song commented: “Such improvements are highly relevant to clinical research laboratories and can positively affect time to results, quality of results, and the processing of challenging tissue samples.”

In addition to the announcement around TSO 500 v2’s launch, Illumina also said that its in vitro diagnostic (IVD), the TruSight Oncology Comprehensive test, which gained approval from the US Food and Drug Administration (FDA) with two companion diagnostics (CDx) indications in August, is now available to ship.

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A busy year for Illumina, the company also recently launched MiSeq i100 and MiSeq 100 Plus, a new benchtop next-generation NGS system designed to be more accessible for use in smaller labs and completed the spin-off of cancer test-maker Grail, which was achieved by distributing 85.5% of Grail’s shares to Illumina’s shareholders, in June.

According to GlobalData, the NGS test devices market will reach a valuation of $5.1bn by 2033. Alongside Illumina, other top players in the space include Thermo Fisher Scientific and Agilent Technologies.