The FDA has granted approval to Illumina's TruSight Oncology (TSO) Comprehensive Assay, marking a significant advancement in precision oncology. This in vitro diagnostic (IVD) kit is the first of its kind to receive FDA approval as a distributable comprehensive genomic profiling tool with pan-cancer companion diagnostic claims.
The TSO Comprehensive Assay is designed to identify adult and pediatric patients with neurotrophic tyrosine receptor kinase (NTRK)-positive solid tumors who may benefit from treatment with larotrectinib (Vitrakvi), and adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) who may benefit from treatment with selpercatinib (Retevmo).
Comprehensive Genomic Profiling
The TSO Comprehensive Assay employs targeted next-generation sequencing to profile over 500 biomarkers, enabling the detection of cancer-driving genetic alterations across various tumor types. This includes single nucleotide variants, multi-nucleotide variants, DNA insertions or deletions, fusions in 24 genes, and splice variants in an RNA gene. The assay also generates a tumor mutational burden (TMB) score.
"The FDA approval for TruSight Oncology Comprehensive with accompanying companion diagnostics marks an awaited milestone for our oncology customers and community," said Everett Cunningham, chief commercial officer of Illumina. "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."
Clinical Utility and Accessibility
Unlike most companion diagnostic tests that are specific to a single tumor type, the TSO Comprehensive Assay is approved across solid tumor indications. In addition to its use as a companion diagnostic in NSCLC and NTRK-positive solid tumors, the assay can provide tumor profiling information for patients with solid malignant neoplasms, supporting personalized treatment decisions.
According to Traci Pawlowski, Illumina vice president and head of clinical solutions, "This approval helps to democratize access to this type of testing, comprehensive genomic profiling, by bringing testing closer to the patient and providing a clearer path to reimbursement." The assay is reimbursable under the Centers for Medicare & Medicaid Services’ national coverage determination for comprehensive genomic profiling assays with companion diagnostic claims for solid tumors.
Future Developments
Illumina is actively expanding its pipeline of companion diagnostic claims for the TSO Comprehensive Assay through partnerships with pharmaceutical companies. Future claims will be added to pending regulatory approvals for the assay, further enhancing its utility in personalized cancer treatment.
Vivek Subbiah, MD, chief of Early-Phase Drug Development at Sarah Cannon Research Institute in Nashville, Tennessee, noted, "Illumina’s newest distributable IVD kit for comprehensive genomic profiling and accompanying companion diagnostic enable another valuable clinical tool for the oncology community to match patients with targeted therapies that can vastly improve their journey and outcomes."
