NEW YORK – Illumina said Tuesday that the US Food and Drug Administration has approved its sequencing-based TruSight Oncology (TSO) Comprehensive assay as a companion diagnostic for kinase inhibitor drugs from Bayer and Lilly.
The assay is now approved to help identify adult and pediatric patients with solid tumors who are positive for NTRK gene fusions and may benefit from Bayer's Vitrakvi (larotrectinib) and to identify adult patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancer who may benefit from Lilly's Retevmo (selpercatinib).
The approvals are the first two companion diagnostic approvals for the assay in the US.
"FDA approval for TSO Comprehensive with accompanying companion diagnostics marks an awaited milestone for our oncology customers and community," Illumina Chief Commercial Officer Everett Cunningham said in a statement. "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's TSO Comprehensive assay detects variants in 517 genes using nucleic acids extracted from formalin-fixed, paraffin-embedded tumor tissue samples of solid malignant neoplasms and runs on the Illumina NextSeq 550Dx sequencer. The test can be used to detect single nucleotide variants, multi-nucleotide variants, insertions, and deletions from DNA, as well as fusions in 24 genes and splice variants in one gene from RNA. The test also reports a Tumor Mutational Burden (TMB) score. Illumina received the CE mark for the assay in 2022 and added a CDx indication to the European version of the assay in 2022 for Bayer's Vitrakvi.
In a statement, Illumina said TSO Comprehensive will begin shipping to US customers this year.
"Illumina has a growing pipeline of CDx claims under development through partnerships with pharmaceutical companies, which will be added to TSO Comprehensive following appropriate regulatory approvals," the firm added. "These CDx claims will help unlock groundbreaking targeted therapies and immunotherapies to make a difference in the lives of patients with cancer."
The company previously announced partnerships with Roche, Bristol Myers Squibb, Myriad Genetics, and Merck.
In Tuesday morning trading on the Nasdaq, shares of Illumina were flat at $130.01.