Illumina has received US FDA approval for its new product, the in vitro diagnostic (IVD) TruSight Oncology (TSO) Comprehensive test, and its first two companion diagnostic indications. This product intends to identify specific gene changes or biomarkers in patients' tumors that can be targeted by therapy. It is set to be delivered to customers later in 2024.

TruSight Oncology Comprehensive is a qualitative in vitro diagnostic test that uses next-generation sequencing to identify variations in 517 genes in cancer patients. The test's major features include its ability to detect single-nucleotide variants, multi-nucleotide variants, insertions and deletions from DNA, fusions in 24 genes, and splice variants in one gene from RNA and to report a Tumor Mutational Burden (TMB) score.

Analyst QuickTake: In May 2022 , Illumina added the CDx indication to its in vitro diagnostic TruSight Oncology tests. The test was already available in Europe and received CE approval in March 2022. The new indication, developed in collaboration with Bayer, was able to identify patients with neurotrophic tyrosine receptor kinase (NTRK) gene mutations who could benefit from Bayer’s VITRAKVI (larotrectinib) targeted therapy.