The FDA has approved Illumina's TruSight Oncology (TSO) Comprehensive test, the first distributable comprehensive genomic profiling in vitro diagnostic (IVD) kit in the U.S.
This test, which examines over 500 genes, is designed to help identify actionable biomarkers in solid tumors, supporting targeted therapy decisions. The initial approval includes two companion diagnostic (CDx) indications for identifying patients with specific gene fusions who may benefit from treatments like Bayer's Vitrakvi (larotrectinib) or Eli Lilly's Retevmo (selpercatinib).
TSO Comprehensive offers a broad molecular profiling tool for cancer patients, particularly those with neurotrophic tyrosine receptor kinase (NTRK) gene fusions or rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). The test's ability to detect a wide range of gene fusions, including novel ones, could enhance the identification of patients who might benefit from specific therapies.
The test is expected to improve access to precision oncology, with its results potentially influencing treatment options and clinical trial eligibility. TSO Comprehensive is set to begin shipping later this year, and it is also covered by Medicare for solid tumor indications with CDx claims.
Illumina is working on expanding the CDx claims for TSO Comprehensive through partnerships with other pharma companies.