Validation of NTRK Fusion Detection Using an Ultrarapid, Fully Automated Cartridge-Based PCR Assay

NTRK gene fusions are rare but actionable oncogenic drivers, and their timely detection is critical for guiding tyrosine receptor kinase–targeted therapy. Conventional methods, such as immunohistochemistry, fluorescence in situ hybridization, RT-PCR, and next-generation sequencing, can be limited by variable sensitivity, cost, and slow turnaround times. The Idylla GeneFusion Assay—a rapid, fully automated cartridge-based platform that infers NTRK1/2/3 fusions through 3′ to 5′ expression imbalance—was evaluated across a retrospective, fusion-enriched cohort of 193 tissue and cytology specimens from The MD Anderson Cancer Center and Mayo Clinic, all of which had prior RNA-based next-generation sequencing profiling.