The U.S. Food and Drug Administration (FDA) has approved the in vitro diagnostic TruSight Oncology (TSO) Comprehensive test and its first two companion diagnostic indications. This targeted sequencing panel interrogates over 500 genes to profile a patient's solid tumor, helping to increase the likelihood of identifying an immuno-oncology biomarker or clinically actionable biomarkers that enable targeted therapy options or clinical trial enrollment.
TSO Comprehensive is FDA-approved as a companion diagnostic to identify adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions that may benefit from treatment with the kinase inhibitor larotrectinib. The test is also approved to identify adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion–positive non–small cell lung cancer (NSCLC) that may benefit from treatment with the kinase inhibitor selpercatinib.
A companion diagnostic test may identify whether a patient's tumor has a specific gene change or biomarker that can be targeted by a therapy, helping to determine if a patient should receive the therapy. Most companion diagnostic tests are specific to one type of cancer, but TSO Comprehensive is approved for use across solid tumor indications for the NTRK companion diagnostic, helping to maximize the chances of finding actionable information from each patient's biopsy.
NTRK gene fusions are rare across most solid cancer tumor types (~0.1%–0.3%) and can be challenging to detect, given that these genes can fuse with different partners, many of which were previously unknown. TSO Comprehensive also interrogates RNA and thus can identify a broad range of known and novel gene fusion partners across all three NTRK gene fusions: NTRK1, NTRK2, and NTRK3. Larotrectinib is a highly selective TRK inhibitor approved for use in patients with TRK fusion–positive cancer, in accordance with therapeutic labeling.
NSCLC is one of the most common types of lung cancer and the leading cause of cancer-related deaths globally. The expansive actionable biomarker landscape in NSCLC has driven the need for broad molecular profiling to enable a complete view of a patient's disease to better guide clinical management. The oncogenic activation of RET fusion–positive NSCLC by gene fusions is a primary driver in NSCLC, occurring in up to 2% of cases. Selpercatinib is a highly selective and potent RET kinase inhibitor active in locally advanced or metastatic NSCLC. TSO Comprehensive enables broad characterization and simultaneous detection of multiple prognostic and predictive biomarkers such as RET, genomic signatures such as tumor mutational burden, and emerging biomarkers within NSCLC in a single test.
Vivek Subbiah, MD
"Through research conducted globally, there is a significant body of evidence demonstrating the clinical utility of comprehensive genomic profiling for patients with advanced cancer," said Vivek Subbiah, MD, Chief of Early-Phase Drug Development at Sarah Cannon Research Institute. "Illumina's newest distributable in vitro diagnostic kit for comprehensive genomic profiling and accompanying companion diagnostics enable another valuable clinical tool for the oncology community to match patients with targeted therapies that can vastly improve their journey and outcomes."
TSO Comprehensive will begin shipping to customers this year. Comprehensive genomic profiling assays with companion diagnostic claims for solid tumors, like TSO Comprehensive, are reimbursable under a Centers for Medicare & Medicaid Service national coverage determination.
