Illumina raised the curtain on a revamp of its flagship tumor profiling test, which aims to offer faster turnarounds, fewer materials and fuller coverage of difficult genomic regions with the goal of helping identify rare cancer biomarkers.
Version 2 of the TruSight Oncology 500 tissue research-use-only assay is currently under development, the company said, with a global release set for mid-2025.
This week’s announcement coincided with the annual meeting of the Association of Molecular Pathology, being held in Vancouver, Canada, where Illumina said it plans to show poster presentations charting preliminary analytical performance data as well as its automation capabilities. The company also said the new kits will require 50% less packaging, and offer flexible batch sizes.
Illumina also reported that the in vitro diagnostic version of its assay—known as TruSight Oncology Comprehensive—has begun shipping to U.S. clinical customers. The pan-cancer tissue profiling test received an approval from the FDA this past August after being available in Europe since 2022.
TSO Comprehensive screens solid tumor samples for 517 genes on the company’s NextSeq 550Dx instrument to find biomarker patterns that can help identify patients who may benefit from specific immunotherapies.
That includes Bayer’s Vitrakvi (larotrectinib) for adult and pediatric patients with certain NTRK mutations, regardless of their type of cancer, as well as Eli Lilly's Retevmo (selpercatinib) among people with RET fusion-positive non-small cell lung cancer—the latter being a new addition over the European version.