The U.S. Food and Drug Administration (FDA) has approved Illumina's TruSight Oncology (TSO) Comprehensive cancer biomarker IVD kit for use as a companion diagnostic (CDx) to match patients to two targeted therapies, Bayer's Vitrakvi (larotrectinib) and Lilly's Retevmo (selpercatinib).
The TSO assay interrogates more than 500 genes to profile a patient's solid tumor, increasing the likelihood of identifying an immuno-oncology biomarker or clinically actionable biomarkers that enable targeted therapy options or clinical trial enrollment, Illumina said in a statement.
TSO Comprehensive is now approved by the FDA for use as a CDx to identify adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions who may benefit from treatment with Viktravi and to identify 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 Retevmo.
Viktravi is a highly selective TRK inhibitor approved for use in patients with TRK fusion cancer. NTRK gene fusions are rare across most solid cancer tumor types, affecting only approximately 0.1% to 0.3% of patients, and may be challenging to detect given that these genes can fuse with different partners. TSO Comprehensive 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, Illumina said.
Retevmo is a highly selective and potent RET kinase inhibitor for locally advanced or metastatic NSCLC; oncogenic activation of RET fusion-positive NSCLC by gene fusions occurs in up to 2% of NSCLC cases. 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, according to Illumina.
A separate CE-marked version of TSO Comprehensive was launched in 2022 and is available in the European Union. TSO Comprehensive kits will ship to U.S. customers this year, Illumina said. Comprehensive genomic profiling assays with CDx claims for solid tumors such as TSO Comprehensive are reimbursable under a U.S. Centers for Medicare and Medicaid Service national coverage determination, the firm noted in its statement.
