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FDA Approves Illumina's TruSight Oncology Test with Two Companion Diagnostics to Accelerate Patient Matching for Targeted Cancer Therapies

NextEdge Admin

30 Aug 2024

2 min 11 sec

Illumina, Inc., a global leader in DNA sequencing, announced FDA approval of its TruSight™ Oncology (TSO) Comprehensive test, along with its first two companion diagnostic (CDx) indications. This in vitro diagnostic (IVD) test profiles over 500 genes from a patient’s solid tumor, increasing the likelihood of identifying actionable biomarkers for targeted therapy or clinical trial enrollment. The test is FDA approved as a CDx for adult and pediatric patients with solid tumors positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions, which may benefit from Bayer's VITRAKVI® (larotrectinib), and for adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC), which may benefit from Lilly's RETEVMO® (selpercatinib).

TSO Comprehensive stands out by its ability to detect a wide range of known and novel gene fusion partners, including NTRK1, NTRK2, and NTRK3. This broad profiling is crucial for conditions like NSCLC, where RET fusions occur in up to 2% of cases and are a key driver of the disease. The test also identifies multiple prognostic and predictive biomarkers, offering a comprehensive view of the patient’s disease.

With a growing pipeline of CDx claims and Medicare reimbursement eligibility, TSO Comprehensive will be available to customers later this year. It aims to advance precision oncology by matching patients with targeted therapies that can significantly improve outcomes.