Illumina has received the US Food and Drug Administration (FDA) approval for its TruSight Oncology (TSO) Comprehensive test for in vitro diagnostic (IVD) use with its first two companion diagnostic (CDx) indications.
The TSO Comprehensive test is now approved as a CDx for identifying both adult and paediatric patients with solid tumours who have neurotrophic tyrosine receptor kinase (NTRK) gene fusions.
It will help identify patients who may benefit from treatment with Bayer’s Vitrakvi (larotrectinib).
Additionally, the test is approved for identifying adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC).
By using the diagnostic test, the eligible patients can be identified for treatment with Lilly’s Retevmo (selpercatinib).
TruSight Oncology Comprehensive is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing to detect variants in 517 genes.
It profiles a patient’s solid tumour, enhancing the detection of immuno-oncology biomarkers and other clinically actionable markers that can guide targeted therapies or clinical trial participation.
Furthermore, the test is approved for all solid tumours for the NTRK CDx, enhancing the chances of finding actionable insights from each biopsy.
TSO Comprehensive analyses RNA to detect a wide range of known and new gene fusion partners across NTRK1, NTRK2, and NTRK3 genes.
In addition, the assay allows for broad characterisation and simultaneous detection of various biomarkers, including RET, tumour mutational burden, and emerging biomarkers in NSCLC, all within a single test.
Illumina chief commercial officer Everett Cunningham said: “FDA approval for TruSight Oncology Comprehensive with accompanying companion diagnostics marks an awaited milestone for our oncology customers and community.
“We are committed to partnering with industry leaders like Bayer and Lilly to advance cancer diagnostics and help broaden access to precision oncology for more patients.”
Illumina plans to ship TSO Comprehensive to customers later this year.
The American biotechnology company is also expanding its pipeline of CDx claims through pharmaceutical partnerships, with plans to incorporate these into TSO Comprehensive following regulatory approval.
Additionally, a CE-marked version of TSO Comprehensive has been available in Europe since 2022.
Last month, Illumina acquired Fluent BioSciences, a single-cell technology developer, to accelerate single-cell analysis and discovery.
In June this year, the biotechnology firm completed the divestiture of GRAIL to make the latter a public and independent company.
